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OBBCQ should have a nice followup on Monday imo
Way to go Z and all the regulars here. This is one board that truely deserves to be spotlighted with all the knowledge. Good nite Players
Good stuff Todd, thanks and we look forward to your input to the board
HI Mick
Looks like it has alot of room to move. It has to hold this base right here for a couple more days imo
OBBCQ -- Orbit Brands Corp.
Com ($0.001)
COMPANY NEWS AND PRESS RELEASES FROM OTHER SOURCES:
Orbit Brands Corp. Subsidiary Floating Bed International Receives Kudos From Resort Hotel Patrons
One Of Many Planned Hotel and Resort Floating Bed Placements In Coming Months Floating Bed Featured in recent issue of 'Plenty Magazine'
LOS ANGELES, April 6, 2006 /PRNewswire-FirstCall via COMTEX/ -- Orbit Brands Corporation ("Orbit") (OTC: OBBCQ) announced today that its wholly-owned subsidiary, Floating Bed International (fka BBKO Corporation) has received another new media placement after its unique bed was installed in Pollywogg Holler, a Mountain Resort/Retreat located in Upstate New York.
William Castle had good feelings when he installed the Floating Bed in his Resort. "The Floating Bed room is our guests' favorite room," says William. "When calling for reservations, the #1 question they ask is whether the Floating Bed is available." After his guests experience it, "They say it is the closest thing they have ever experienced to sleeping on a cloud." It has received more media attention too. Mr. Castle's resort, complete with a photo of the Floating Bed, was featured in a recent issue of Plenty Magazine (http://www.plentymag.com). Floating Bed CEO, John Huff, added, "This is one of many planned Floating Bed hotel and resort placements you will see in the coming months. The Floating Bed is a very desirable product for hotels. If your business is about sleep, it makes sense to have the best bed in the world. Users often comment that they have never slept better than in the Floating Bed. Hotels are a great way to introduce individuals to it; then it sells itself. With 6 billion potential customers worldwide using this product 8 hours a day, our company is poised for dramatic growth. Who wouldn't want the best bed available?"
About Orbit Brands Corp.
Orbit is a publicly traded Delaware corporation listed on the OTC Pink Sheets. The primary focus of the company is growth via the acquisition and development of early-stage, high-growth companies in the technology, health and fitness, and consumer goods industries. Orbit is positioned to identify, acquire, fund and develop these companies for the purpose of creating business and shareholder value.
About Floating Bed International
Floating Bed International is a specialty bed manufacturer. It designs and manufactures beds that are uniquely advantageous for the human mind and body by focusing on improving blood circulation. With its true pendulum motion, the "Floating Bed" actually balances the hemispheres of the brain, thereby inducing a relaxed, meditative state to facilitate faster and deeper sleep. For further information, please visit the company's website at http://www.floatingbed.com.
FORWARD LOOKING STATEMENTS: Statements regarding financial matters in this press release other than historical facts constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. The Company intends that such statements about the Company's future expectations, including future revenues and earnings, and all other forward- looking statements, shall be subject to the safe harbors created thereby. Since statements related to future operational results and sales involve risks and uncertainties and are subject to change at any time, the Company's actual results may differ materially from the expected results.
BUYINS.NET: CWF, THLD, IDSA, DALRQ, TFTG, NIVM Have Been On BUYINS.NET Naked Short List For 13 Consecutive Trading Days
Mar 31, 2006 (M2 PRESSWIRE via COMTEX) -- BUYINS.NET, www.buyins.net, announced today that these select companies have been on the NASDAQ, AMEX and NYSE naked short threshold lists for 13 consecutive trading days: Chartwell Dividend and Income Fund, Inc. (NYSE: CWF), Threshold Pharmaceuticals, Inc. (NASDAQ: THLD), Industrial Services of America, Inc. (NASDAQ: IDSA), Delta Air Lines, Inc. (OTC: DALRQ), Trimfast Group, Inc (OTC: TFTG), National Investment Managers, Inc. (OTCBB: NIVM). For a complete list of companies on the naked short lists please visit our web site. To find the SqueezeTrigger Price before a short squeeze starts in any stock, go to www.buyins.net.
Regulation SHO took effect January 3, 2005, and provides a new regulatory framework governing short selling of securities. It was designed with the objective of simplifying and modernizing short sale regulation and providing controls where they are most needed. At the conclusion of each settlement day, data is provided on securities in which: 1) there are at least 10,000 shares in aggregate failed deliveries for the security for five consecutive settlement days, and 2) these failures constitute at least 0.5% of the issuer's total shares outstanding. Regulation SHO mandates that, if a clearing agent has had a fail-to-deliver position for 13 consecutive settlement days, that clearing agent, and the broker/dealer it clears for, must purchase securities to close out its fail to deliver position.
Chartwell Dividend and Income Fund, Inc. (NYSE: CWF) operates as a closed-end, management investment company. The fund invests primarily in equity securities that include common stocks, convertible securities, preferred stocks, and other equity-related securities. In addition, it invests in nonconvertible debt securities, including corporate bonds. Its portfolio includes investments in capital goods, consumer cyclical, consumer staples, energy, financial, health care, industrial, real estate, telecommunications, transportation, utilities sectors. Chartwell Investment Partners, L.P. serves as the investment manager of the fund. The fund was incorporated in 1998 and is based in Berwyn, Pennsylvania. With 16.69 million shares outstanding and 240,070 shares declared short as of February 2006, the failure to deliver in shares of CWF has not been resolved and a buy-in is imminent.
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) a development stage company, engages in the discovery, development, and commercialization of small molecule therapeutics for the treatment of benign prostatic hyperplasia and cancer. Its product candidates include TH-070, a Phase II and III product, which is used for the treatment of symptomatic benign prostatic hyperplasia; Glufosfamide, a Phase II and III product, for the treatment of cancer; 2-deoxyglucose, or 2DG, a Phase I trail product, for the treatment of solid tumors. The company was founded by George F. Tidmarsh. Threshold Pharmaceuticals was incorporated in 2001 and is headquartered in Redwood City, California. With 37.24 million shares outstanding and 342,376 shares declared short as of February 2006, the failure to deliver in shares of THLD has not been resolved and a buy-in is imminent.
Industrial Services of America, Inc. (NASDAQ: IDSA) a logistic management services company, offers waste and recycling management services to commercial, industrial, and logistic customers in the United States, Canada, Puerto Rico, and Mexico. The company operates in three segments: ISA Recycling, Computerized Waste Systems (CWS), and Waste Equipment Sales and Service (WESSCO). ISA Recycling segment provides products and services related to ferrous, nonferrous, and fiber recycling. It purchases and sells ferrous and nonferrous materials, fiber scrap, cardboard, and paper. CWS segment provides waste disposal services, including contract negotiations with service providers, centralized billing, invoice auditing, and centralized dispatching. WESSCO segment sells, leases, and services waste handling and recycling equipment. The company was incorporated in 1953 under the name Alson Manufacturing, Inc. and subsequently changed its name to Industrial Services of America, Inc. Industrial Services of America is headquartered in Louisville, Kentucky. With 3.58 million shares outstanding and 55,709 shares declared short as of February 2006, the failure to deliver in shares of IDSA has not been resolved and a buy-in is imminent.
Delta Air Lines, Inc. (OTC: DALRQ) through its wholly owned subsidiaries, Atlantic Southeast Airlines, Inc. and Comair, Inc., operates as an air carrier, which provides scheduled air transportation for passengers and cargo in the United States and internationally. As of September 1, 2005, the company served 178 domestic cities in 46 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as 58 international cities in 35 countries. It operates a fleet of approximately 7,587 flights. Delta Air Lines was founded in 1924 and is headquartered in Atlanta, Georgia. The company and its subsidiaries filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in September 2005. The company operates its business as debtor-in-possession. With 189.34 million shares outstanding and an undisclosed short position, the failure to deliver in shares of DALRQ has not been resolved and a buy-in is possible.
Trimfast Group, Inc (OTC: TFTG) through its wholly owned subsidiary, Sur Services, Inc., supplies prepaid, and reloadable stored value ATM and MasterCard cards. It also provides value added products, such as roadside assistance, prepaid legal, and long distance phone card services. Sur Services' cards also allow users to share access to their accounts from multiple locations, both nationally and internationally. The company, formerly known as HLHK World Group, Inc., is based in Torrance, California. With 2.71 million shares outstanding and an undisclosed short position, the failure to deliver in shares of TFTG has not been resolved and a buy-in is possible.
National Investment Managers, Inc. (OTCBB: NIVM) primarily provides pension consulting services and administrative services for retirement plans primarily in New York. The company also provides financial advisory services to small businesses and high net worth individuals. In addition, it sells insurance products through licensed and authorized brokers and agents. National Investment Managers, Inc. is based in New York City. With 13.65 million shares outstanding and an undisclosed short position, the failure to deliver in shares of NIVM has not been resolved and a buy-in is possible.
About BUYINS.NET
WWW.BUYINS.NET is a service designed to help bonafide shareholders of publicly traded US companies fight naked short selling. Naked short selling is the illegal act of short selling a stock when no affirmative determination has been made to locate shares of the stock to hypothecate in connection with the short sale. Buyins.net has built a proprietary database that uses Threshold list feeds from NASDAQ, AMEX and NYSE to generate detailed and useful information to combat the naked short selling problem. For the first time, actual trade by trade data is available to the public that shows the attempted size, actual size, price and average value of short sales in stocks that have been shorted and naked shorted. This information is valuable in determining the precise point at which short sellers go out-of-the-money and start losing on their short and naked short trades.
BUYINS.NET has built a massive database that collects, analyzes and publishes a proprietary SqueezeTrigger for each stock that has been shorted, www.buyins.net/squeezetrigger.pdf. The SqueezeTrigger database of nearly 650,000,000 short sale transactions goes back to January 1, 2005, and calculates the exact price at which the Total Short Interest is short in each stock. This data was never before available prior to January 1, 2005, because the Self Regulatory Organizations (primary exchanges) guarded it aggressively. After the SEC passed Regulation SHO, exchanges were forced to allow data processors like Buyins.net to access the data.
The SqueezeTrigger database collects individual short trade data on over 7,000 NYSE, AMEX and NASDAQ stocks and general short trade data on nearly 8,000 OTCBB and PINKSHEET stocks. Each month the database grows by approximately 50,000,000 short sale transactions and provides investors with the knowledge necessary to time when to buy and sell stocks with outstanding short positions. By tracking the size and price of each month's short transactions, BUYINS.NET provides institutions, traders, analysts, journalists and individual investors the exact price point where short sellers start losing money.
All material herein was prepared by BUYINS.NET, based upon information believed to be reliable. The information contained herein is not guaranteed by BUYINS.NET to be accurate, and should not be considered to be all-inclusive. The companies that are discussed in this opinion have not approved the statements made in this opinion. This opinion contains forward-looking statements that involve risks and uncertainties. This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. BUYINS.NET is not a licensed broker, broker dealer, market maker, investment banker, investment advisor, analyst or underwriter. Please consult a broker before purchasing or selling any securities viewed on or mentioned herein. BUYINS.NET may receive compensation in cash or shares from independent third parties or from the companies mentioned.
BUYINS.NET affiliates, officers, directors and employees may also have bought or may buy the shares discussed in this opinion and may profit in the event those shares rise in value. Market commentary provided by Thomas Ronk.
BUYINS.NET will not advise as to when it decides to sell and does not and will not offer any opinion as to when others should sell; each investor must make that decision based on his or her judgment of the market.
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a companies' annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission.
You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and BUYINS.NET undertakes no obligation to update such statements.
CONTACT: Thomas Ronk, CEO Tel: +1 800 715 9999 e-mail: Tom@buyins.net WWW: http://www.buyins.net
M2 Communications Ltd disclaims all liability for information provided within M2 PressWIRE. Data supplied by named party/parties. Further information on M2 PressWIRE can be obtained at http://www.presswire.net on the world wide web. Inquiries to info@m2.com.
(C)1994-2006 M2 COMMUNICATIONS LTD
**********************************************************************
As of Monday, 03-27-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 02-14-2006 for CWF @ $11.02.
(C) 2006 Comtex News Network, Inc. All rights reserved.
-0-
Absolutely, the recent filing shows a total turnaround for the most part and the sector is the hottest.
NNLX is looking good again for this week imo
CTUM in consolidating nicely imo. Might be ready later this week
NAUG float is 9.76 mil according to most recent filing
AMEP has been a beast lately
The chart certsinly looks ready imo
Also ATWT is looking ready to go next week imo
I do belive that ADVC is primed for a move next week. If it breaks .0033 the reversal should be confirmed with vollume
i also bought some at .003 last week and have an alert set for .0033 and will add if the volume is there again
I do beleive we can make a difference Penny as this board will be a Pot of Gold imo
I agree avbout the resistance at .0032, I think it will be Tuesday imo. I really like ATWT and OBCCQ also.
OBBCQ should have a nice pop on Monday with the volume surge and weekend for it to be seen by others. Good things happening for this one imo
ADVC has looked primed for a couple of days. Hopefully the push will be this week
I just saw the alert. At what price was the alert please.
I also think that ARGY and IPRE are very solid plays for tomm imo
Agreed and lately its a pr machine which is helping imo
Trade, any thoughts on PGPU in your opinion
gm trade
GM mick
Very interesting stock here and on the move. PGPU
Any thoughts, looks like a winner to me
April 12, 2006 - 10:36 AM EDT
PGPU 0.19 0.01
Pinnacle/Maverick Energy Announce Wells Producing Above Expectations
Pinnacle Group (OTC: PGPU) is pleased to announce it will be issuing highlights from the recent interview of Maverick Energy Group CEO James McCabe in his exclusive interview with Wall Street Reporter over the next few days. The entire interview can be heard at www.wallstreetreporter.com, or from the link on the website of PGPU at www.pinnaclegli.com. Either method will provide a free registration sign up. The following are some of the highlights gathered from Mr. McCabe's interview.
-- The four natural gas wells mentioned in a previous news release are
producing above expectations and 10 more wells are due to be completed by
the end of this quarter.
-- The company presently has 5000 acres under lease for natural gas
production in W. Virginia with a target of 50,000 acres by the end of the
year. That target is well within reach stated Mr. McCabe. The company
continues to expand throughout the Appalachian Basin as well as moving into
Pennsylvania.
-- The company crown jewel is its operational contract and participation
in the Big Foot Field in West Texas. There are 300 producing wells and 300
projection wells.
Further information can be found at http://www.maverickenergygroup.com/ or www.pinksheets.com
This release includes forward-looking statements, which are based on certain assumptions and reflects management's current expectations. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. Some of these factors include: general global economic conditions; general industry and market conditions and growth rates; uncertainty as to whether our strategies and business plans will yield the expected benefits; increasing competition; availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology; changes in laws and regulations, includes codes and standards, intellectual property rights, and tax matters; the uncertainty of the oil & gas market; including the geopolitical environment not anticipated; our ability to secure and maintain strategic relationships and distribution agreements. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Market Wire (April 12, 2006 - 10:36 AM EDT)
News by QuoteMedia
www.quotemedia.com
IHDR also had a pullback today and might be a good buy at this level
gm all
I emailed ChoiceTrade and they did confirm that they accept stop limits on OTCBB and Pinkies fwiw. Im gonna call them tommorow and confirm this.
Great sight and charts. I was gonna search this sector and happened to see the board and have favorite placed it. Thanks a million and lets ride the wave
997,684,354
ACHI is another that looks primed to run imo. Any thoughts
Any thought on DRDF. They have a proposed R/S of 200/1 in May but the charts look they have reversed at least short tern to me. Any thoughts would be appreciated
Interesting, and it is very user freindly in learning I assume. I checked out the site last night and it seems to have alot to offer. I need all the signals I can get and info as I do this as I can during the day and trying to get to 25k and get out of this 3 trade rule in 5 days. That can be very constricting and my timing is still off by a few days on a stock sometimes. Started at 5k and up to 8k in 2 months but also got some nice winners to help the effort, but I know I am still off a little on timing lol.Thanks so much and I love this board as everyone is very helpful and there for everyone which is nice to be a part of :)
HI Trade
Will it give signals to work for otcbb stocks for short term trading, say 1 to 3 day holds as alerts....TIA
NOVN NEWS
WASHINGTON - The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
ADVERTISEMENT
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami.
In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
Unlike pill forms of the drug, the patch can be removed if it causes side effects.
Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday.
U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals.
Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear.
The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.
"We feel that the labeling approved with this product is adequate and adequately provides for safe and effective use," said Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products. The companies have pledged to study the sensitization issue, he added.
Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve.That panel, the FDA's Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.
The patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, Laughren said. The patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate.
The patch will be available in four doses: 10, 15, 20 and 30 milligrams per nine hours, Laughren said.
NOVN NEWS
WASHINGTON - The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
ADVERTISEMENT
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami.
In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
Unlike pill forms of the drug, the patch can be removed if it causes side effects.
Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday.
U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals.
Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear.
The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.
"We feel that the labeling approved with this product is adequate and adequately provides for safe and effective use," said Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products. The companies have pledged to study the sensitization issue, he added.
Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve.That panel, the FDA's Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.
The patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, Laughren said. The patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate.
The patch will be available in four doses: 10, 15, 20 and 30 milligrams per nine hours, Laughren said.
NOVN NEWS
WASHINGTON - The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
ADVERTISEMENT
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami.
In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
Unlike pill forms of the drug, the patch can be removed if it causes side effects.
Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday.
U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals.
Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear.
The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.
"We feel that the labeling approved with this product is adequate and adequately provides for safe and effective use," said Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products. The companies have pledged to study the sensitization issue, he added.
Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve.That panel, the FDA's Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.
The patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, Laughren said. The patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate.
The patch will be available in four doses: 10, 15, 20 and 30 milligrams per nine hours, Laughren said.
NOVN NEWS
WASHINGTON - The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
ADVERTISEMENT
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami.
In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
Unlike pill forms of the drug, the patch can be removed if it causes side effects.
Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday.
U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals.
Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear.
The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.
"We feel that the labeling approved with this product is adequate and adequately provides for safe and effective use," said Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products. The companies have pledged to study the sensitization issue, he added.
Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve.That panel, the FDA's Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.
The patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, Laughren said. The patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate.
The patch will be available in four doses: 10, 15, 20 and 30 milligrams per nine hours, Laughren said.
NOVN NEWS
WASHINGTON - The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
ADVERTISEMENT
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami.
In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
Unlike pill forms of the drug, the patch can be removed if it causes side effects.
Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday.
U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals.
Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear.
The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.
"We feel that the labeling approved with this product is adequate and adequately provides for safe and effective use," said Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products. The companies have pledged to study the sensitization issue, he added.
Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve.That panel, the FDA's Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.
The patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, Laughren said. The patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate.
The patch will be available in four doses: 10, 15, 20 and 30 milligrams per nine hours, Laughren said.