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Titan Pharmaceuticals, Inc.
 
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                  5/26/2016-FDA Approves First Buprenorphine Implant For Treatment Of Opioid Dependence
 
                                             Expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid epidemic



 

 

The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

Until today, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved. While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis. An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year.

"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Expanding the use and availability of medication-assisted treatment (MAT) options like buprenorphine is an important component of the FDA’s opioid action plan and one of three top priorities for the U.S. Department of Health and Human Services’ Opioid Initiative aimed at reducing prescription opioid and heroin related overdose, death and dependence.

Opioid dependence is the diagnostic term used for the more common concept, “addiction,” in the Probuphine clinical trials. Addiction is defined as a cluster of behavioral, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use, persisting in drug use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, as well as the possibility of the development of tolerance or development of physical dependence. Physical dependence is not the same as addiction. Newer diagnostic terminology uses the term “opioid use disorder,” which includes both milder forms of problematic opioid use as well as addiction.

MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use, without causing the cycle of highs and lows associated with opioid misuse or abuse. At sufficient doses, it also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for their opioid use disorder cut their risk of death from all causes in half.

“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” said Nora Volkow, M.D., director of the National Institute on Drug Abuse at the National Institutes of Health. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”

Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provide treatment for six months. Administering Probuphine requires specific training because it must be surgically inserted and removed. Only a health care provider who has completed the training and become certified through a restricted program called the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program should insert and remove the implants. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring postmarketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.

The safety and efficacy of Probuphine were demonstrated in a randomized clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment. A response to MAT was measured by urine screening and self-reporting of illicit opioid use during the six month treatment period. Sixty-three percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64 percent of those who responded to sublingual (under the tongue) buprenorphine alone.

The most common side effects from treatment with Probuphine include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain. The safety and efficacy of Probuphine have not been established in children or adolescents less than 16 years of age. Clinical studies of Probuphine did not include participants over the age of 65.

Probuphine has a boxed warning that provides important safety information for health care professionals, including a warning that insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure. Probuphine must be prescribed and dispensed according to the Probuphine REMS program because of the risks of surgical complications and because of the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin. As part of this program, Probuphine can only be prescribed and dispensed by health care providers who are certified with the REMS program and have completed live training, among other requirements.

Probuphine implants contain a significant amount of drug that can potentially be expelled or removed, resulting in the potential for accidental exposure or intentional misuse and abuse if the implant comes out of the skin. Patients should be seen during the first week after insertion and a visit schedule of no less than once-monthly is recommended for continued counseling and psychosocial support.

Probuphine is marketed by San Francisco-based Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals based in Princeton, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

 

CLINICAL SUMMARY

SIX CLINICAL STUDIES COMPLETED TO DATE WITH FINAL PHASE 2 STUDY UNDER WAY
1 Initial small dose finding study
2 & 3 Two well-controlled Phase 3 safety and efficacy studies showing clinical and statistical superiority over placebo and non-inferiority to Suboxone published in Journal of American Medical Association and Addiction
4 & 5 Two open-label long-term treatment safety studies
6 Relative bioavailability study



 
STUDY RESULTS
  • Mild-to-moderate adverse events typical of the safety profile of buprenorphine; low number of serious adverse events similar to placebo
    Well-tolerated implant procedure
    No evidence of implant diversion or misuse

KEY BENEFITS

EFFICACY

Effective in reducing illicit opioid use

COMPLIANCE

Treatment with the ProNeura™ implant is expected to enhance patient compliance

SAFETY

Non-fluctuating drug exposure over six months may provide superior safety and tolerability

EASE OF USE

Patients are dosed once every six months in an outpatient setting

 

PRONEURA™

Titan's proprietary long-term, drug delivery platform provides continuous drug release and non-fluctuating medication levels over a period of three months to a year depending on drug characteristics. ProNeura products are subdermal implants that are ideal for treating chronic diseases for which the maintenance of stable medication levels could offer advantages over other routes of administration.

   OVERVIEW

    ProNeura offers continuous drug delivery and consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (“EVA”) and a drug substance.                                                     .   The resulting product is a solid matrix that is placed subcutaneously, normally in the inner part of the upper arm in a simple office procedure, and is 
    removed in a similar manner at the end of the treatment period.

   
    This continuous drug delivery technology was developed to address the need for a simple, practical method to potentially provide continuous drug administration on an 
    outpatient basis over extended periods of up to 6 to 12 months.

Overview

 

 

 

 

Continuous Drug Delivery Technology

 

 

The continuous drug delivery system consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (“EVA”) and a drug substance. The resulting product is a solid matrix that is placed subcutaneously, normally in the inner part of the upper arm in a simple office procedure, and is removed in a similar manner at the end of the treatment period. The drug substance is released slowly, at continuous levels, through the process of dissolution. This results in a stable blood level similar to intravenous administration. Such long-term, linear release characteristics are generally desirable as this avoids peak and trough level dosing that poses problems for many Central Nervous System (“CNS”) and other disease settings. 

This continuous drug delivery technology was developed to address the need for a simple, practical method to potentially provide continuous drug administration on an outpatient basis over extended periods of up to 6-12 months. In addition to Probuphine, which is the first product to complete clinical testing that has utilized this proprietary continuous drug delivery technology, Titan has conducted initial non-clinical studies with long-term delivery of dopamine agonists demonstrating the potential of this product in the treatment of Parkinson’s disease in non-clinical models of the disease.

 


 


Company Overview



 

Titan Pharmaceuticals, Inc. is a biopharmaceutical Company developing proprietary therapeutics primarily for the treatment of serious medical disorders.


Titan’s principal asset is Probuphine®, the first slow-release implant formulation of buprenorphine hydrochloride (“buprenorphine”), designed to maintain a stable, round-the-clock blood level of the medicine in patients for up to six months following a single treatment. The outpatient treatment of opioid dependence with daily dosed sublingual buprenorphine formulations represents a $1.5 billion market in the U.S., and a seven day transdermal patch formulation of buprenorphine for the treatment of chronic pain was launched in the U.S. in 2011. This novel implant formulation is inserted subdermally in a patient’s upper arm providing continuous medication, and has the potential to enhance patient compliance to treatment, and limit diversion for illicit use and accidental exposure to the sublingual formulations. An FDA-requested Phase 3 study is currently in progress with completion expected in mid-2015 and resubmission of the New Drug Application later in 2015. In December 2012, Titan entered into a license agreement with Braeburn Pharmaceuticals Sprl (“Braeburn”) that grants Braeburn exclusive commercialization rights to Probuphine® in the United States and Canada. Titan received a non-refundable up-front license fee of $15.75 million and will receive a $15 million milestone payment upon the approval of the NDA by the FDA. Additionally, Titan will be eligible to receive up to $165 million upon achievement of specified sales milestones and up to $35 million in regulatory milestones in the event of future NDA submissions and approvals for additional indications, including chronic pain. Titan will receive tiered royalties on net sales of Probuphine ranging from the mid-teens to the low twenties.


Probuphine is the first product to utilize ProNeura™, a novel, proprietary, long-term drug delivery technology. The ProNeura technology has the potential to be used in developing products for the treatment of other chronic conditions, such as Parkinson’s disease, where maintaining stable, round-the-clock blood levels of a drug can benefit the patient and improve medical outcomes.


Finally, Titan has monetized substantially all of the future royalty revenue of 8-10% of net sales of Fanapt® (iloperidone), an atypical antipsychotic compound being marketed in the U.S. for the treatment of schizophrenia by Novartis Pharma AG (“Novartis”). The future royalty revenue has been sold to Deerfield Management (“Deerfield”), a healthcare investment fund, in exchange for cash and debt considerations which have been used to advance the development of Probuphine and for general corporate purposes.

 

 

Management Team

President
Sunil Bhonsle, M.B.A.

Executive Vice President and Chief Development Officer

Katherine L. Beebe, Ph.D.

Executive Chairman

Marc Rubin, M.D.

 



Board of Directors

 
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News News Alert: Braeburn Pharmaceuticals Announces FDA Approves Probuphine® (buprenorphine) Implant: The First Implant for Treatment of Opio... 05/26/2016 07:26:00 PM
PostSubject
#8841  Sticky Note FDA Approves First Buprenorphine Implant For Treatment Of TRUTH 05/26/16 03:09:13 PM
#8916   hope next week TTNP goes teens - prevention kei 05/26/16 07:55:59 PM
#8915   yap! all kinds of media will pick up kei 05/26/16 07:36:32 PM
#8914   She's moving up nicely now! Tom should be interesting. bee500 05/26/16 07:33:43 PM
#8913   ASHP Guidelines On The Pharmacy And Therapeutics Committee TRUTH 05/26/16 07:26:45 PM
#8912   TTNP ---> $8.35 now \(^_^)/ kei 05/26/16 07:24:46 PM
#8911   Implant To Curb Opioid Addiction Approved By FDA, TRUTH 05/26/16 07:09:44 PM
#8910   FORTUNE: The First Implant To Treat Opioid Addiction TRUTH 05/26/16 07:00:41 PM
#8909   most the people that need this are not Rentier 05/26/16 06:57:27 PM
#8908   what we really want is it to be TRUTH 05/26/16 06:54:32 PM
#8907   Look at where VNDA's market cap is currently Rentier 05/26/16 06:53:10 PM
#8906   what is fair value now regarding pps? TRUTH 05/26/16 06:51:39 PM
#8905   I'm curious to see how the negotiation process Rentier 05/26/16 06:50:44 PM
#8904   Yes....it's considered a milestone payment. TRUTH 05/26/16 06:45:53 PM
#8903   Congratulations Truth...! TRUTH 05/26/16 06:43:11 PM
#8902   Great synopsis with that being said what is netbruh 05/26/16 06:29:54 PM
#8901   Thank you very much. Didn't think I dranesthesia1 05/26/16 06:28:19 PM
#8900   They get the 15 million for approval? dranesthesia1 05/26/16 06:27:32 PM
#8899   This is just the beginning for the pro TRUTH 05/26/16 06:21:07 PM
#8898   Yeah. So no what? Hope for a buy bee500 05/26/16 06:10:49 PM
#8897   Stock hit $9.29 after-hours as it's high. Rentier 05/26/16 06:08:11 PM
#8896   So right in after hours it looks like interstate 05/26/16 06:07:03 PM
#8895   Congratulations Truth...! Rentier 05/26/16 06:02:53 PM
#8894   Psst. FDA requires a Black Box Label on Rentier 05/26/16 06:00:31 PM
#8893   Could be a buyout on Tuesday if the FBI Agent 05/26/16 05:55:50 PM
#8892   Congrats to all! CNBC is reporting a ekmey 05/26/16 05:50:08 PM
#8891   Hey truth. Initiated in AH. I dranesthesia1 05/26/16 05:48:43 PM
#8890   Persistence (praying) overcame resistance. ;-) TRUTH 05/26/16 05:47:34 PM
#8889   I'm adding here and will wait till the aringbearer 05/26/16 05:39:16 PM
#8888   No... Thank you, my posting days are over TRUTH 05/26/16 05:35:43 PM
#8887   Was really hoping we see at least 10 bee500 05/26/16 05:33:24 PM
#8885   small trades going through at 7.50-7.60 right now noretreat 05/26/16 05:32:06 PM
#8884   Black Box Label..... If a patient is stable davidsson10 05/26/16 05:31:11 PM
#8883   I am so happy for you, for all bigstocksnbonds 05/26/16 05:25:42 PM
#8882   No... Thank you, my posting days are over aringbearer 05/26/16 05:25:38 PM
#8881   TRUTHfully...I couldn't be more happier for you Truth. Doctor Detroit 05/26/16 05:22:34 PM
#8880   TTNP TRADING RESUMES 17:25 TRUTH 05/26/16 05:17:47 PM
#8879   Halt lifed at 5:25 today perhaps... aringbearer 05/26/16 05:10:30 PM
#8878   Trade resumes at 5.25pm. Hold on! buckiii2 05/26/16 05:10:08 PM
#8877   Same here. The chills haven't left my body. 3steve3 05/26/16 05:08:02 PM
#8876   So the stock was halted through the close? noretreat 05/26/16 05:02:15 PM
#8875   I could not be happier to see this. BaylorTradeKing 05/26/16 04:57:24 PM
#8874   TITAN PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF PROBUPHINE(R) FOR TRUTH 05/26/16 04:56:05 PM
#8873   Never fall in love with a stock TRUTH 05/26/16 04:53:12 PM
#8872   I can't wait to see the companies press Jkings 05/26/16 04:43:25 PM
#8871   A Matchstick-Size Implant That Could Be An Answer TRUTH 05/26/16 04:39:37 PM
#8870   thank you truth!! kei 05/26/16 04:31:51 PM
#8869   CONGRATS TO ALL!!!! bluejacket6 05/26/16 04:30:25 PM
#8868   FDA Approves Implant To Treat Opioid Dependence TRUTH 05/26/16 04:28:58 PM
#8867   BLOOMBERG: First Implant to Treat Opioid Addiction Gets Doctor Detroit 05/26/16 04:24:25 PM
#8866   ABC NEWS-FDA Approves First Drug-Oozing Implant To Control Addiction TRUTH 05/26/16 04:23:59 PM
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