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Exactly.
The FDA interacts well before the NDA step.
The FDA would have long ago intervened if it was an issue. That's the simple resolution to the whole discussion about blue dye. Not a chance it makes it this far if the blue dye was a problem. I say this as someone very familiar with the FDA.
The message is starting to sink in.
he is acting like its never been used in a drug before.
Objective observers are not having a problem.
The use of manufactured blue tint feeding tubes has NEVER been evaluated by the FDA for safety or utility (i.e., there has NEVER been an evaluation by the FDA of the sensitivity and specificity of FD&C Blue No. 1 dye use in the manufacturing of feeding tubes).
And finally here's the current top Medications with FD&C Blue No. 1 excipient...all of which are FDA approved speaking of bogus ethical nightmares duhhhhhhhhhhhh:
Any legit user would be well below the 12.0 milligrams/kilogram body weight/day allowance so this is a mute point. Move on now.
More like BAIL OUT negotiations...
Buy out negotiations may be the best explanation for delay in Rexista FDA filling????????
An easy experiment.
I don't recommend this with any of the meds you listed because most are either stimulants or sedatives, but it would be okay to do this with Aleve, which is a light blue caplet. According to its product info sheet, it uses a form of Blue #2 called blue #2 lake, which is one of hundreds of FDA certified varieties of Blue #2. Now take that Aleve caplet and chew it up until it is all dissolved in your mouth. Now go look at yourself in the mirror. Have your lips, gums, and teeth turned to an intense blue color? Of course not, because Aleve uses blue #2 as a general use color additive. To the contrary, Rexista uses Blue #1 or Blue #2 as an ACTIVE INGREDIENT, which will require a much higher dose of blue dye, two times per day, every day, forever. And with zero benefit to the legitimate user. The truth is clear to everyone who is not in DENIAL. Rexista is a ticking time bomb AND an ethical nightmare.
http://labeling.bayercare.com/omr/online/aleve-caplets.pdf
Inactive ingredients FD&C blue #2 lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Try as you may try as you might the only one confused here is you with your 100% false claims that Rexista's blue dye is supposedly a concern hahahahahahahaha!!!
Top Medications with FD&C Blue No. 1 excipient:
Acetaminophen and Hydrocodone Bitartrate 650 mg / 10 mg (Watson Laboratories, Inc.)
Acetaminophen and Hydrocodone Bitartrate 500 mg / 7.5 mg (Qualitest Pharmaceuticals Inc.)
Alprazolam 1 mg (Qualitest Pharmaceuticals Inc.)
Amitriptyline Hydrochloride 25 mg (Mylan Pharmaceuticals Inc.)
Amphetamine and Dextroamphetamine 10 mg (Teva Pharmaceuticals USA)
Cephalexin Monohydrate 500 mg (Teva Pharmaceuticals USA)
Clonazepam 1 mg (Mylan Pharmaceuticals Inc.)
Clonazepam 1 mg (Teva Pharmaceuticals USA)
Clonazepam 1 mg (Qualitest Pharmaceuticals Inc.)
Diazepam 10 mg (Watson Pharmaceuticals)
Diazepam 10 mg (Mylan Pharmaceuticals Inc.)
Gabapentin 300 mg (Actavis Elizabeth LLC)
Hydroxyzine Pamoate 25 mg (Teva Pharmaceuticals USA)
Loperamide Hydrochloride 2 mg (Major Pharmaceuticals Inc.)
Oxycodone Hydrochloride 30 mg (Qualitest Pharmaceuticals Inc.)
Oxycodone Hydrochloride 15 mg (Qualitest Pharmaceuticals Inc.)
Percocet 325 mg / 5 mg (Endo Pharmaceuticals)
Phentermine Hydrochloride 37.5 mg (KVK Tech Inc.)
Phentermine Hydrochloride 37.5 mg (Qualitest Pharmaceuticals Inc.)
Phentermine Hydrochloride 37.5 mg (Sun Pharmaceutical Industries Inc.)
You require remediation on food dyes.
100% pure and utter nonsense as the FDA's APPROVED color additive list for DRUGS, food and cosmetic products is 100 miles long hahahahhaahhaa>>>
www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm106626.htm
http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Other blue dyes, such as methylene blue and FD&C Blue No. 2, may have similar if not greater toxicity potential than Blue 1 and would not be appropriate replacements.
The facts are clear.
lmfao IPCI isn't manufacturing feeding tubes...and the 20 cited possible cases from that FDA feeding tube article from 13 years ago are 100% irrelevant to the FDA approved water-soluble blue dye that's in 1000's of drugs, foods and cosmetic products in use on a daily basis by millions of people!
This is the only RELEVANT FACT directly from the FDA when it comes to FDA approved water soluble blue dye in drugs, food and cosmetic products>>>
Quote:
There have been no reports of toxicity associated with this general use.
100% Complete Confidence
Again 100% complete nonsense and blatantly false that Rexista could cause users to turn blue and die hahahhaahah
IPCI's Rexista OxyContin NDA isn't 2 quarters behind schedule hahahahahahaha
Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
James P. Maloney, M.D.
Medical College of Wisconsin, Milwaukee, WI 53226
Ann C. Halbower, M.D.
Brian F. Fouty, M.D.
Karen A. Fagan, M.D.
Vivek Balasubramaniam, M.D.
Adrian W. Pike, Ph.D.
Paul V. Fennessey, Ph.D.
Emory University, Atlanta, GA 30322
Marc Moss, M.D.
University of Colorado, Denver, CO 80262
Endo wouldn't touch Rexista with a ten-foot pole.
And not to forget, Endo had a lot of problems with its opioid painkiller Opana! So IPCI having Rexista and their ANADs would be a perfect fit for Endo.
ELI-201 Competitor Rexista May Have Blue Dye Problem
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125369441
Rexista users could turn blue and die.
The delay in Rexista filing is most likely due to a safety concern. My best guess is that it has something to do with the "stigmatizing blue dye" that is touted as an ADF feature. If the drug is chewed, the abuser's teeth, lips, and oral mucosa are colored with a deep blue dye. This presents several dilemmas...
Rexista's Blue Dye Problem
But the turning blue & pissing blue & shitting blue & bleeding blue & then croaking blue is a real damn thing. If the blue dye is going down the same hole, then it makes no difference if the dye came from a tablet or a tube feed. They are both going into the stomach and processing through the G.I. tract. And the tube feeds were short-term, but Rexista will deliver blue dye forever.
Want to be part of human experiments?
Ask your doctor to change your oxycodone prescription to Rexista so we can learn for the first time about the effects on human beings of long-term twice-daily exposure to concentrated blue dye. If this were a true controlled study, you would have to sign a special ethics statement that you were aware that the concentrated blue dye could not possibly provide you with any benefit whatsoever.
The NEW ENGLAND JOURNAL of MEDICINE
Systemic Absorption of Food Dye in Patients with Sepsis
N Engl J Med 2000; 343:1047-1048October 5, 2000DOI: 10.1056/NEJM200010053431416
Citing Articles (29)
To the Editor:
Critically ill patients who are receiving enteral feeding are susceptible to pulmonary aspiration of gastric contents. Measures to enhance the early detection of aspiration include the tinting of feedings with the food dye FD&C blue no. 1. During sepsis, gastrointestinal permeability increases because of enterocyte death and loss of barrier function at intercellular gaps. Thus, substances that are otherwise nonabsorbable may be absorbed during sepsis. We report two deaths associated with the systemic absorption of blue dye no. 1 from enteral feedings; in both cases, the absorption was heralded by the appearance of blue or green skin and serum.
A 54-year-old woman with chronic renal failure was hospitalized for congestive heart failure and confusion. Hemodialysis and nasogastric feeding were initiated. Later, staphylococcal pneumonia with sepsis was attributed to aspiration, prompting the addition of blue dye no. 1 to her enteral feedings. The patient was febrile but hemodynamically stable until two days later, when her skin and serum turned green. She died of refractory hypotension and acidosis that day.
A 12-month-old boy with trisomy 21 underwent tracheostomy for obstructive apnea. Pseudomonas pneumonia with sepsis developed; aspiration was believed to have occurred. Blue dye no. 1 was added to his enteral feedings. He remained hemodynamically stable, with normal renal function, until the next day, when his skin, serum, and urine became blue and hyperthermia developed (rectal temperature, 47°C). He died of refractory hypotension and acidosis that day.
Neither patient had bacteremia. Autopsies of both patients revealed green or blue discoloration of the skin and internal organs, without gastrointestinal perforation. Light-spectroscopic analysis of the child's serum and of the stock of blue dye no. 1 revealed identical, single absorption peaks at 629 nm (a peak that was absent in control serum), confirming the systemic absorption of dye. Although the blue tinting of feedings was visually titrated at our institutions, it is unlikely that oral-intake limits established by the Food and Drug Administration (FDA) for blue dye no. 1 (12 mg per kilogram of body weight per day)3 were exceeded. The adult patient had renal failure, which is notable given that this dye is cleared by the kidneys.
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
James P. Maloney, M.D.
Medical College of Wisconsin, Milwaukee, WI 53226
Ann C. Halbower, M.D.
Brian F. Fouty, M.D.
Karen A. Fagan, M.D.
Vivek Balasubramaniam, M.D.
Adrian W. Pike, Ph.D.
Paul V. Fennessey, Ph.D.
University of Colorado, Denver, CO 80262
Marc Moss, M.D.
Emory University, Atlanta, GA 30322
5 References
You're citing a friggin' 13 year old FDA report
Oh, I've seen it. BIG problems here.
lmfao try reading their recently released food effects PR
The study design was a randomized, one-treatment two periods, two sequences, crossover, open label, laboratory-blind bioavailability study for RexistaTM XR following a single 80 mg oral dose to healthy adults under fasting and fed conditions.
Want to be part of human experiments?
Ask your doctor to change your oxycodone prescription to Rexista so we can learn for the first time about the effects on human beings of long-term twice-daily exposure to concentrated blue dye. If this were a true controlled study, you would have to sign a special ethics statement that you were aware that the concentrated blue dye could not possibly provide you with any benefit whatsoever.
https://cspinet.org/new/pdf/food-dyes-rainbow-of-risks.pdf
Summary
Food dyes, synthesized originally from coal tar and now petroleum, have long been controversial. Many dyes have been banned because of their adverse effects on laboratory animals. This report finds that many of the nine currently approved dyes raise health concerns.
Blue 1 was not found to be toxic in key rat and mouse studies, but an unpublished study suggested the possibility that Blue 1 caused kidney tumors in mice, and a preliminary in vitro study raised questions about possible effects on nerve cells. Blue 1 may not cause cancer, but confirmatory studies should be conducted. The dye can cause hypersensitivity reactions.
Blue 2 cannot be considered safe given the statistically significant incidence of tumors,particularly brain gliomas, in male rats. It should not be used in foods.
The NEW ENGLAND JOURNAL of MEDICINE
Systemic Absorption of Food Dye in Patients with Sepsis
N Engl J Med 2000; 343:1047-1048October 5, 2000DOI: 10.1056/NEJM200010053431416
Citing Articles (29)
To the Editor:
Critically ill patients who are receiving enteral feeding are susceptible to pulmonary aspiration of gastric contents. Measures to enhance the early detection of aspiration include the tinting of feedings with the food dye FD&C blue no. 1.1 During sepsis, gastrointestinal permeability increases because of enterocyte death and loss of barrier function at intercellular gaps. Thus, substances that are otherwise nonabsorbable may be absorbed during sepsis. We report two deaths associated with the systemic absorption of blue dye no. 1 from enteral feedings; in both cases, the absorption was heralded by the appearance of blue or green skin and serum.
A 54-year-old woman with chronic renal failure was hospitalized for congestive heart failure and confusion. Hemodialysis and nasogastric feeding were initiated. Later, staphylococcal pneumonia with sepsis was attributed to aspiration, prompting the addition of blue dye no. 1 to her enteral feedings. The patient was febrile but hemodynamically stable until two days later, when her skin and serum turned green. She died of refractory hypotension and acidosis that day.
A 12-month-old boy with trisomy 21 underwent tracheostomy for obstructive apnea. Pseudomonas pneumonia with sepsis developed; aspiration was believed to have occurred. Blue dye no. 1 was added to his enteral feedings. He remained hemodynamically stable, with normal renal function, until the next day, when his skin (Figure 1FIGURE 1
Blue Discoloration of the Skin in a 12-Month-Old Boy Who Had Received Enteral Feedings Tinted with FD&C Blue Dye No. 1.
), serum, and urine became blue and hyperthermia developed (rectal temperature, 47°C). He died of refractory hypotension and acidosis that day.
Neither patient had bacteremia. Autopsies of both patients revealed green or blue discoloration of the skin and internal organs, without gastrointestinal perforation. Light-spectroscopic analysis of the child's serum and of the stock of blue dye no. 1 revealed identical, single absorption peaks at 629 nm (a peak that was absent in control serum), confirming the systemic absorption of dye. Although the blue tinting of feedings was visually titrated at our institutions, it is unlikely that oral-intake limits established by the Food and Drug Administration (FDA) for blue dye no. 1 (12 mg per kilogram of body weight per day)3 were exceeded. The adult patient had renal failure, which is notable given that this dye is cleared by the kidneys.
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
James P. Maloney, M.D.
Medical College of Wisconsin, Milwaukee, WI 53226
Ann C. Halbower, M.D.
Brian F. Fouty, M.D.
Karen A. Fagan, M.D.
Vivek Balasubramaniam, M.D.
Adrian W. Pike, Ph.D.
Paul V. Fennessey, Ph.D.
University of Colorado, Denver, CO 80262
Marc Moss, M.D.
Emory University, Atlanta, GA 30322
5 References
Rexista's Blue Dye Problem
The dye is batch certified by the FDA and is widely used in food products (candies, confections, beverages, etc.) in amounts consistent with good manufacturing practices (generally at parts per million). There have been no reports of toxicity associated with this general use.
SUMMARY OF REPORTS
As of September, 2003, the FDA is aware of 20 cases from the scientific literature or in FDA post-marketing adverse event reports associating the use of blue dye in tube feedings with blue discoloration of body fluids and skin, as well as more serious complications. There have been 12 reported deaths and one case with an unknown outcome.
In more than 75% of all reported cases, patients had a reported history of sepsis (and therefore likely altered gut permeability) before or during systemic absorption of Blue 1.
Time of onset of toxicity from first use of Blue 1 varied from several hours to 20 days of continuous use in enteral feedings.
At this time, the FDA believes practitioners should be aware of the following points:
Use of Blue 1-tinted enteral feedings for detecting aspiration has been associated with several serious adverse events, including death, although a direct causal relationship has not been definitely established.
The safety of Blue 1-tinted enteral feedings for detecting aspiration has not been documented.
Based on the reports received to date, patients at risk for increased intestinal permeability, which includes those with sepsis, burns, trauma, shock, surgical interventions, renal failure, celiac sprue, or inflammatory bowel disease, appear to be at increased risk of absorbing Blue 1 from tinted enteral feedings.
In addition to the possibility of systemic toxicity, Blue 1-tinted enteral feedings may interfere with diagnostic stool examinations, such as the hemoccult test.
Other blue dyes, such as methylene blue and FD&C Blue No. 2, may have similar if not greater toxicity potential than Blue 1 and would not be appropriate replacements.
Rexista users could turn blue and die.
Has there ever been an explanation for the delay in the rexista nda? First it was Q2/Q3 in their January biotech presentation, then it was June/July (in March at the Roth presentation) then it was August (in the PR updating rexista progress) and now we believe sometime in the next 2 months (based on their Rodman presentation).
FDA Public Health Advisory: Subject: Reports of Blue Discoloration and Death in Patients Receiving Enteral Feedings Tinted With The Dye, FD&C Blue No. 1
September 29, 2003
Dear Health Care Professional:
The Food and Drug Administration (FDA) would like you to be aware of several reports of toxicity, including death, temporally associated with the use of FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. In these reports, Blue 1 was intended to help in the detection and/or monitoring of pulmonary aspiration in patients being fed by an enteral feeding tube. Reported episodes were manifested by blue discoloration of the skin, urine, feces, or serum and some were associated with serious complications such as refractory hypotension, metabolic acidosis and death.
As of September, 2003, the FDA is aware of 20 cases from the scientific literature or in FDA post-marketing adverse event reports associating the use of blue dye in tube feedings with blue discoloration of body fluids and skin, as well as more serious complications. There have been 12 reported deaths and one case with an unknown outcome.
Other blue dyes, such as methylene blue and FD&C Blue No. 2, may have similar if not greater toxicity potential than Blue 1 and would not be appropriate replacements.
I have no interest in a discussion.
You can be part of the discussion or just someone who is saying "everybody here is reading fables, I'm the one who knows the right company".
Seriously ??
You should post one. Everyone can play.
I already found plenty of real quotes
Preclinical studies of Rexista™ Oxycodone XR suggest that if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
You are quoting another poster from this board.
Formulations already tested with PODRAS include: Oxycodone, Hydrocodone, Oxymorphone, Hydromorphone, Codeine, and Morphine. + all of those in combination with Acetaminophen or other NSAIDs (e.g. from about 50 mg to about 900 mg).
From quickly perusing the article some of the formulations already tested with PODRAS include: Oxycodone, Hydrocodone, Oxymorphone, Hydromorphone, Codeine, and Morphine. + all of those in combination with Acetaminophen or other NSAIDs (e.g. from about 50 mg to about 900 mg).
Absolutely incorrect, already answered by the company.
I think most are assuming there are two formulations. But it is possible that there could be only one formula for both current Rexista and the future Rexista incorporating PODRAS. I believe PODRAS is just two extra coatings of chemicals.
But they're also working simultaneously on an enhanced version of Rexista which will incorporate their PODRAS tech...but obviously due to what PODRAS can do ie: stop over-doses...the enhanced version of Rexista incorporating the PODRAS tech is going to require a lot of clinical trials and human abuse testing still...so we'll be hearing a lot more about the enhanced version of Rexista incorporating PODRAS after the PODRAS patent gets granted soon k!
Make no mistake about it though...Domenic was adamant that the potential best-in-class designation on Rexista incorporating npodds is still their expectation ok! The Rexista version incorporating PODRAS will simply be an enhanced improvement on their already best-in-class Rexista designation k cheers~
FALSE: "PODRAS is already part of the formula in Rexista."
Not only is PODRAS not currently in the formula, it's not even currently a real thing. It's an idea which has been patented. The extensive clinical trial & error to get it to work will take multiple years and more likely than not will never work. Functional or not, it'll cost $25-50 million, maybe more, to figure out. Acura is working on very similar concept. They're multiple years ahead of IPCI, they have funding, and they have an actual research staff-- none of which IPCI currently has. Here's what Bob Jones said in a recent conference call about how much progress they've made in TWO YEARS:
In April we announced results of cohort one from study 400 which demonstrated that a three tablet dose of one of our test formulations LTX-04P lowered the relative maximum blood level of hydromorphone by approximately 22% compared to a non abuse deterrent version. This result exhibited the ability of LIMITX technology to retard the release of active ingredient when multiple tablets are ingested and makes it a viable abuse deterrent platform. The one and two tablet doses of LTX-04P did not deliver the active drug as we would expect for an immediate release dosage form which will require us to reformulate the microparticles in tablets that contain the active drug.
Simple facts, basic speculation.
First they say Q2 then Q3 then Q4. The waiver was because it is the first NDA from a small cap pharma- has zero to do with the merits of Rexista. Likewise, the company merely reported the food effect study, not any commentary from FDA. When the company repeatedly misses their own deadlines, then it welcomes speculation as to why. My speculation is just as valid as any others, and in the eyes of an objective observer, more valuable than the offerings of someone who only sees sunshine and roses.
Speaking of LOL, NDA application for nPODDDs is delayed because they're waiting for patent approval for PODRAS. Hilarious.
Robert Califf's FDA putting the brakes on Rexista?
More than one opioid company has gotten unexpected bad news since Cahill took over the FDA. Last we heard of an FDA opinion on Rexista was in May 2015, when IPCI reported the FDA letter that said no Phase 3 was required. Califf took over FDA a year later, in April 2016, after a significant public scolding from the U.S. Senate regarding the FDA's opioid approval process -AND- the FDA's cozy relationship with drug companies.
There have been many changes at the FDA since IPCI released any public info regarding current FDA guidance on Rexista. The company has now missed multiple self-imposed deadlines for Rexista NDA filing. While there are many possible explanations for this, one significant possibility is that the company does not feel confident with the application based on their most recent discussions with Robert Califf's "New" FDA.
https://www.ket.org/opioids/dr-robert-califf-on-the-fdas-action-plan-for-drug-addiction/
“There’s no question but that, over the last 10 to 15 years, there’s been too much opioid prescribing, and I think that almost everyone now is familiar with the history here,” Califf says.
...
Califf feels strongly about the responsibility of the pharmaceutical industry to reform its marketing practices. “There’s no question that the history of marketing opioids is a sinister part of American history that will be looked back upon very negatively,” he says.
You didn't miss a thing.
Been away for quite some time now.
Can anyone give me a quick recap about the status of SequestOx since the response letter? Where are we at?
Great stuff, N2K. Thanks.
Excluding foreign businesses operating in China, the fact is that no Chinese business exists without the blessing of the government. And, this blessing includes the access to deep pockets.
China Comes to Grips With Opioids
The painkillers work, but the Chinese worry about addiction.
Bruce Einhorn
Bloomberg Businessweek
March 31, 2016 — 1:55 PM EDT
More than most countries, China has good reason to be wary of opioids, synthetic drugs like OxyContin that share opium’s power to suppress pain. In the 19th century the nation lost two wars to the British in a futile attempt to keep opium out of the country. After the defeats, part of what the Chinese call their century of humiliation, millions of people became addicted to the drug: In the early 1900s more than 25 percent of Chinese men used opium regularly. One of the government’s proudest achievements after the communists took power in 1949 was wiping out “the scourge of opium,” as China’s State Council put it. Partly out of that historic sensitivity, China today restricts the use of opioids far more tightly than the U.S. and other Western countries.
So, while the government is encouraging local drug companies to do more research and development on opioids, says Zhenjiang Yue, chief executive officer of Aoxing Pharmaceutical, the official approach to prescription painkillers “is still very restrictive.” Aoxing last year received a license to make tilidine opioid tablets, a painkiller widely used in Germany.
In China, outpatients are allowed prescriptions for no more than seven days’ worth of regular narcotics. Cancer patients can get prescriptions for up to 15 days but must first receive a document from a qualifying hospital certifying that they need treatment using narcotics. To keep track of the drugs, doctors who administer injectable opioids must return the empty drug vials. “Once, we accidentally broke a used bottle, and the doctor, the hospital manager, and I each had to write a self-criticism,” says Ni.
You're almost there...
The drug you just show has no generics. It's still on patent.
NDA #21-742 patent expiration 4/8/20.
First to file?
There can't be much revenue in beta blockers if you can get 90 pills for $4.
I know all about ticks.
Just what it says; but fist one has to understand what a tick is. right?
JL what does this mean?
9. Trade with the TICK not against it. Don't be a hero. Go with the
money flow.
Treppel converted his Preferred already.
As others have noted, with this conversion, we are running tight up against total authorized shares (have to leave enough of a cushion for Treppel to convert his Preferred, too).
Why convert the Preferred?
If this is true then my assessment was wrong about Nasrat converting to common in order to use the remainder of the Lincoln Park funds.
Does anybody actually have a good educated reason as to why he converted to common shares?
Lots of people are saying it's just because he hit his 3 year mark and it's a non-issue and nothing more.
What would be the purpose of converting to common shares at his 3 year mark?
Does changing the RLD mean all previous trial work has to be redone because it's all based on comparisons to Roxicodone?
What makes SequestOx more likely to be accepted than what happened to Avridi?
Remember, Avridi has detergent-based ADF, so the major high-fat food effect makes sense. SequestOx is a standard capsule and should act more similar to Lehigh Valley generic capsules and less like Avridi
Currently-approved oxycodone 5mg capsules have Tmax after high-cal meal of 3 hours. Bioequivalence standards require SequestOx to be within 125%, or 3 hours 45 minutes. If SequestOx fed Tmax is equal to or less than 3 hours 45 minutes, then it is already bioequivalent to Lehigh Valley NDA #200-534 and could be immediately approved in 5mg size if RLD is changed.
Based on my guesstimation, if Avridi reported fed Tmax as “mean” instead of “median”, it would look even worse, greater than 5 hours (and therefore outside the bioequivalence range of even the Lehigh Valley capsules).
Generic epi-pen needs to be submitted.
The Senator’s Daughter Who Raised Prices on the EpiPen
by
Anna Edney
Billy House
August 24, 2016 — 5:00 AM EDT
Updated on August 24, 2016 — 1:16 PM EDT
Members of Congress are in an unusual position as they demand an explanation for Mylan NV’s 400 percent price hike for the EpiPen and focus attention squarely on its CEO: Heather Bresch.
If lawmakers follow the usual script, Bresch could get called up to Capitol Hill next month to explain her company’s justification for raising the price on the life-saving allergy shot. But that could be awkward, since she’s the daughter of Democratic Senator Joe Manchin of West Virginia.
Pediatric pain is under-recognized and under-treated.
Children knock each other up at age 11 so what's to say the FDA isn't just a little irresponsible in approving this opioid without
a robust ADF inside? Some kids this age shoot heroin.
Good move FDA. Just keep SequestOx IR shelved and let companies like Purdue (yeah I read the article where they claim they aren't going to sell to "children") peddle their stuff to kids.
Why Aren’t We Managing Children’s Pain?
By Rachel Rabkin Peachman
June 27, 2016 2:36 pm
Many doctors and parents also fear that pain medications, whether or not they are warranted, will have dangerous side effects on children, such as developmental problems and addiction. Current scientific evidence, however, supports a different conclusion.
“Research shows that poorly managed pain exposures early in life can actually change the wiring in the brain and prime children to be more sensitive to it later on, putting them at risk for developing chronic pain in childhood and adulthood,” said Anna C. Wilson, a child psychologist and assistant professor of anesthesiology at the Pediatric Pain Management Center at Oregon Health & Science University. And while babies or young children may not consciously remember it later in life, their nervous systems will.
But there is reason for optimism. Contrary to previous conventional thinking, the effective use of pain medication for children does not hinder brain development, according to several studies. “We know that giving strong pain medications to very young children does not interfere with their neurodevelopment later on,” Dr. Friedrichsdorf said.
Research has also shown that the appropriate medical use of prescription pain medications, such as opioids, when properly monitored, does not lead to addiction in young children and adolescents, Dr. Friedrichsdorf added.
Endo has no ADF.
Endo's ADF version of Opana is a trainwreck. Easily IV abused and directly implicated in outbreaks of HIV and Hep C, as well as an acquired clotting disorder and infective endocarditis. They should just give up and call Nasrat for a buyout price.
http://www.fiercepharma.com/pharma/endo-withdraws-bid-to-add-abuse-deterrent-to-opana-s-label
Endo withdraws bid to add 'abuse deterrent' to Opana's label
by Carly Helfand | Aug 12, 2016 11:53am
Endo is putting the brakes on its bid to label its opioid pain med Opana ER "abuse deterrent."
On Friday, the Dublin drugmaker said it had decided to withdraw its supplemental new drug application related to the labeling, and it now plans to drum up and analyze more data surrounding the med.
"We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance Opana ER," Sue Hall, the company’s R&D head, said in a statement.
The move follows controversy surrounding the med and the role it played in last year’s HIV outbreak in southern Indiana. As the CDC and local officials determined, the outbreak resulted from addicts dissolving and injecting Opana ER--a possibility regulators warned Endo about in May of 2013.
Please provide link for this.
Quote:
Nasrat agreed to hold his preferred shares for 3 years and those 3 years are just now up .....
Item 1.01 Entry into a Material Definitive Agreement.
On February 7, 2014, Elite Pharmaceuticals, Inc. (the “Company”) and Elite Laboratories, Inc., its wholly-owned subsidiary, amended the
following convertible promissory notes: (i) an August 1, 2013 Secured Convertible Note to Mikah Pharma LLC (“Mikah”) due August 1, 2016
in the principal amount of $10,000,000 (the “Mikah Note”), and (ii) a November 21, 2013 Convertible Note to Jerry Treppel due November 21,
2016 in the principal amount of $600,000 (the “Treppel Note” and, together with the Mika Note, the “Notes”). Mikah is owned by the
Company’s CEO and President and Mr. Treppel is a director of the Company. Generally, the Notes were amended to make them convertible
into shares of the Company’s newly created Series I Convertible Preferred Stock. For a description of this new series of preferred stock, please
see “Item 5.03” below. The Mikah Note also was amended to make it immediately exercisable.