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Tag Archives: Purdue Pharma
Generic Opana to remain on the market: FDA
The U.S. Food and Drug Administration said Friday it will continue to allow sales of the generic version of the painkiller Opana that does not include an abuse-resistant feature.
Opana’s manufacturer, Endo Pharmaceuticals, had submitted a petition to the agency asking it to ban generic forms of the painkiller, which Endo has reformulated as “Opana ER” to make it harder to abuse. That petition was denied by the FDA, which said Endo’s reformulation was not significantly safer than the original version:
While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing. Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.
Endo’s petition came after Purdue Pharma successfully asked the FDA to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make it more difficult to crush, break, or dissolve.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, Endo Pharmaceuticals, FDA, narcotics, OP, Opana, Opana ER, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pills, politics, prescription drug abuse, Purdue Pharma, Schedule II narcotics
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Painkiller market to reach $8.4B by 2017: WSJ
Prescription painkiller sales are set to increase by 15% and hit $8.4 billion by 2017, due in part to the U.S. Food and Drug Administration’s recent decision to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse. Experts are predicting a race across the pharmaceutical industry to create a market where all opioids have abuse-deterrent properties, according to the Wall Street Journal.
According to the FDA, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”
OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation, Trends
Tagged addiction, Big Pharma, FDA, hydrocodone, narcotics, Opana, opiates, oxy, oxycodone, OxyContin, pain medication, painkillers, pills, politics, prescription drug abuse, Purdue Pharma, Roxycodone, Schedule II narcotics, Vicodin, Xanax
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FDA bans copycat versions of original Oxy amid abuse concerns
The U.S. Food and Drug Administration said Tuesday it will not approve any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse.
According to the agency, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”
OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.
The FDA’s decision came on the same day that Purdue’s patent on the original OxyContin expired, which normally opens the door for generic drug makers to launch their own cheaper versions of a product. Now, these generic companies will have to develop their own abuse-deterrent designs, preserving Purdue’s monopoly on the OxyContin market for the time being.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged abusable, abuse-deterrent, addiction, anti-abuse, Big Pharma, FDA, generics, narcotics, OP, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, prescription drug abuse, prescriptions, Purdue Pharma, reformulation, Schedule II narcotics, tamper-proof
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Generic Oxy in N.Y. will enable abusers: Schumer
New York Sen. Charles Schumer is calling for added safety features to be imposed on generic forms of the prescription painkiller OxyContin that are set to hit the market in April. The lawmaker says he fears that these copycat versions, which do not include anti-abuse protections that cause them to turn into gels or chunks when crushed, could enable abusers, according to this article.
Many popularly abused prescription painkillers, including OxyContin, have been reformulated in recent years to allegedly make them abuse-resistant. But generic manufacturers are bringing their own versions of such drugs to market that don’t include tamper-proof properties.
The reformulation of OxyContin has prompted painkiller addicts across the country to switch to other opiates as well as heroin, recent research has shown.
Oxycodone prescriptions in Staten Island — which ranks third in oxycodone prescriptions per capita in the state — have remained relatively steady, with 141,022 written last year, compared to 142,059 in 2011, according to the article.
Overdose is now the leading cause of accidental death in New York, where almost 22.5 million prescriptions for all types of narcotic painkillers were written in in 2010, according to a recent report issued by the state’s attorney general.
Fentanyl, hydromorphone replacing Oxy in Canada
Tighter controls on the popularly abused painkiller OxyContin in Canada have had positive results, but experts say the country’s massive pill addiction problem is still spiraling out of control: in 2010, for the first time, Canada surpassed the United States to become the highest opioid-consuming country, per capita, in the world, according to this article.
Moreover, in 2011, twice as many Ontarians were killed by opioid overdoses as drivers killed in car accidents, and addiction treatment programs are overflowing with people addicted to publicly funded drugs, the article adds.
As you may remember, OxyContin manufacturer Purdue Pharma replaced the painkiller last March in Canada with OxyNEO, an alternative billed as “tamper-resistant” because it is harder to crush. Today, Ontario’s OxyNEO prescriptions are about 60% what OxyContin prescriptions were a year ago; in Newfoundland, they’re 22%; in B.C., 67%, according to the article.
But other long-acting opioids such as fentanyl and hydromorphone — including Hydromorph Contin, also made by Purdue — are now among the fastest-growing causes of Ontario’s opioid overdose deaths, the article says.
Posted in Informational, Trends
Tagged addiction, Big Pharma, Canada, Deaths, fentanyl, hydrocodone, Hydromorph Contin, hydromorphone, narcotics, OP, opiates, opioid, overdose, oxy, oxycodone, OxyContin, OxyNEO, pain medication, painkillers, prescription drug abuse, Purdue Pharma, Schedule II narcotics
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How did we get here?
The numbers are staggering: in the United States, the number of overdose deaths from prescription opioids has more than tripled in the past decade, resulting in nearly 15,000 fatalities in 2008 alone and now accounting for more than 40 deaths every single day – not to mention the fact that estimated annual health care costs from this epidemic are as high as $72.5 billion.
How did we get here?
In the latest issue of Emergency Medicine News, Dr. Leon Gussow, a physician and editor of The Poison Review blog, examines how opioid analgesics – once feared as dangerous medications with high risk for addiction and overdose – became the drug class most frequently prescribed in the U.S., with four million patients a year receiving scripts for these powerful medications.
Posted in Editorial, Informational, Pain Advocates, Pharmaceutical Industry, Trends
Tagged addiction, Big Pharma, Deaths, FDA, heroin, hydrocodone, narcotics, Opana, opiates, opioid, overdose, overdoses, oxy, oxy-to-heroin, oxycodone, OxyContin, pain management history, pain medication, painkillers, Percocet, pills, politics, prescription drug abuse, Purdue Pharma, Russell Portenoy, Schedule II narcotics, Teen deaths, Vicodin, Xanax
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FDA mulls hydrocodone reclassification
This week, the U.S. Food and Drug Administration is set to conduct a two-day hearing on whether hydrocodone products such as Vicodin should be more highly regulated like other narcotics like OxyContin and morphine, this article reports. FDA researchers said in recent briefing documents that while chronic pain patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction, the article says. But critics say hydrocodone is potent and highly addictive, and that updating the drug’s classification could help bring the prescription drug addiction epidemic under control, according to the article.
Last year, pharmacy interest groups defeated an amendment to the FDA Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II.
Combination hydrocodone products such as Vicodin and Norco are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.
The amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization bill would have rescheduled hydrocodone from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, FDA, hydrocodone, narcotics, opiates, oxycodone, OxyContin, pain medication, painkillers, Percocet, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Purdue Pharma, reclassification, Schedule II narcotics, Schedule III narcotics, Vicodin
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NYPD to use GPS ‘bait bottles’ to track illegal pill sales
The New York Police Department says it plans to use an innovative approach to combat the theft of painkillers by asking pharmacies to hide fake pill bottles fitted with GPS devices amid the legitimate supplies on their shelves, this article reports. The NYPD says the initiative was prompted by a rash of high-profile crimes associated with the thriving black market for oxycodone and other prescription drugs in recent years, including the slaying of four people on Long Island during a pharmacy holdup in 2011, the article says. Officers will ask roughly 6,000 pharmacists and 1,800 pharmacies in the New York City area to adopt use of the bottles, which can be tracked in the event of a robbery or theft.
The GPS devices will be provided by Purdue Pharma, the manufacturer of OxyContin – the most-abused medicine in the United States.
New York has suffered brutally at the hands of the prescription drug addiction epidemic, and experts say things have only gotten worse since the quadruple homicide at a Medford, N.Y. pharmacy in 2011. According to this article, there were 92 instances in Nassau in 2011 in which prescription opioids were linked to overdose deaths – a tally higher than either of the previous two years and more than triple the 2004 figure. Forty-five of those deaths happened after the Medford killings, the article says.
Posted in Crime, Informational, Policy & Regulation
Tagged Big Pharma, Crime, doctor shopping, GPS, narcotics, NYPD, opiates, oxycodone, OxyContin, pain medication, painkillers, pharmacy, pill mills, pills, prescription drug abuse, prescriptions, Purdue Pharma, robberies, Schedule II narcotics
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U.S. drug officials fear flood of generic Oxy
U.S. drug officials are warning police and border guards to be on the lookout for Canadian generic versions of the widely abused painkiller OxyContin after the Canadian government gave the stamp of approval to six generic versions of the drug. According to this article, the warnings have come from U.S. drug czar Gil Kerlikowske and Montana’s attorney general Steve Bullock, and the U.S. Office of National Drug Control Policy has issued a notice stating that “the potential exists for diversion into the United States because the old formulations, which are easier to abuse, are unavailable in the United States.”
Health Canada opened the door for generic versions of OxyContin in November following the expiration of the patent held by Purdue Pharma for its long-acting formulation of oxycodone, the active ingredient in OxyContin. The move came despite urgings from some of the country’s leading pain doctors and researchers to hold off, according to this article.
OxyContin in Canada was phased out earlier this year by Purdue and replaced by an abuse-resistant version known as OxyNEO. But the newly-approved generics will use the same older formulation in the now discontinued Oxy-Contin, the article notes.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, Canada, narcotics, OP, opiates, opioid, oxy, oxycodone, OxyContin, OxyNEO, pain medication, painkillers, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Purdue Pharma, Schedule II narcotics
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Canada OKs generic Oxy that isn’t abuse-resistant
The Canadian government has given the stamp of approval to six generic versions of the widely abused painkiller OxyContin, despite urgings from some of the country’s leading pain doctors and researchers to hold off, according to this article.
The green light from Health Canada came just after the expiration of the patent held by Purdue Pharma for its long-acting formulation of oxycodone, the active ingredient in OxyContin, the article says.
OxyContin in Canada was phased out earlier this year by Purdue and replaced by an abuse-resistant version known as OxyNEO. But the newly-approved generics will use the same older formulation in the now discontinued Oxy-Contin, the article notes.
Canadians are the second-largest consumers of prescription narcotics and other controlled substances per capita in the world, according to the International Narcotics Control Board.
Posted in Informational, Trends
Tagged abuse-resistant, addiction, Big Pharma, Canada, narcotics, OP, opiates, overdoses, oxy, oxycodone, OxyContin, OxyNEO, pain medication, painkillers, pharmaceutical, pills, prescription drug abuse, prescriptions, Purdue Pharma, Schedule II narcotics
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