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Endo Pharmaceuticals has agreed to pull Opana ER from the U.S. market, several weeks after being asked to do so by the FDA. The abuse-deterrent extended-release formulation of the opioid painkiller oxymorphone hydrochloride has been tagged by an Agency safety committee as too easily…

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recently reported, the FDA asked Endo to remove Opana ER from the market in June, based on a review of “postmarketing data” which revealed that addicts were easily overcoming the abuse-deterrent formulation and injecting the drug.

Needle-sharing – even among members of the same family – has been the source of the spread of HIV and Hep-C infections. And Opana ER abuse has also been found to be the source of ‘thrombotic microangiopathy’ among abusers. This rare but serious blood clotting disorder damages the tiny blood vessels in the body’s vital organs, most commonly the kidney and brain, and can be fatal.

A single Opana ER pill contains an average 12-hour dose of oxymorphone. The drug is 10 times as potent as morphine, and is intended only for serious pain control.

However, when abusers crush, dissolve and inject it, that huge 12-hour dose of oxymorphone is suddenly an overdose risk for any but seasoned addicts.

Of course, needle sharing by infected users raises the public health threat to the level of a disaster.

Not the first time

According to the FDA statement, “this is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”

Well, that statement is not 100% accurate. Back in 1979, the agency asked Endo Pharmaceuticals to remove its oxymorphone painkiller pills, called Numorphan, from the market.

That less-than-timely request followed a vicious epidemic of overdoses, ruined lives and deaths directly caused by diverted Numorphan pills, and which went on for 20 years – from 1959 to 1979 – before anyone did anything about it.

Neither the FDA nor Endo Pharmaceuticals admitted publicly they had anything to do with the epidemic or why Numorphan pills were suddenly pulled from the market.

Although the Numorphan pills were withdrawn, the Numorphan name remained on several injectable and rectal oxymorphone medications from Endo.

The new epidemic isn’t news either

As we reported two years ago, Opana ER was a favorite of opioid addicts centered around Austin, IN, and elsewhere for years.

One has to ask why the FDA sat idle for at least two years while the epidemic spread, claiming over 120 victims in the tiny city of Austin, IN, pop. 4,200 – and beyond. Or why the agency was paralyzed for 20 years while Numorphan ravaged the opioid addiction underworld through the ‘60s and ‘70s.

One also has to wonder why, in 2006, the FDA “reapproved” Endo’s Numorphan oxymorphone pills under a new trade name, Opana. And then in 2011, the agency approved the extended release Opana ER.

Bottom line, this is not the first time the FDA has asked for a market removal “due to the public health consequences of abuse.” Today’s Opana ER is essentially the same product, albeit extended release, that the FDA had Endo remove from the market 38 years ago because of abuse.

In its favor, Endo says it will coordinate the orderly removal of Opana ER from the market with the FDA, so that patients have enough time to seek alternative treatment options.

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New FDA Commissioner Scott Gottlieb, MD, says the agency wants to know whether abuse-deterrent prescription opioids "are having their intended impact on limiting abuse and helping to curb the epidemic." To help get a meaningful answer, Gottlieb has called a public meeting for July 10 and 11,…

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issues paper outlining existing regulatory and public health challenges.

As we reported two weeks ago, the new Commissioner told his first staff meeting that “our greatest immediate challenge is the problem of opioid abuse.” This was followed by the news a week later that the FDA has asked for an abuse-deterrent prescription painkiller, Opana ER, to be taken off the market because it’s been so widely abused.

“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof,” Gottlieb said in a lengthy statement about expanding the FDA’s role in combating the opioid epidemic. “These drugs can still be abused, particularly orally, and their use can still lead to new addiction.”

However, the Commissioner said, these new formulations “may hold promise” as part of a broad effort to reduce abuse.

“We recognize there is a gap in our understanding of whether these products result in a real world, meaningful decrease in the frequency and patterns of opioid misuse and abuse,” he said. “One thing is clear: We need better scientific information to understand how to optimize our assessment of abuse deterrent formulations.”

In his statement, Gottlieb said that “everyone at the FDA is committed to focusing on all aspects of the epidemic.” As part of this program, a steering committee is being formed to examine “additional regulatory and policy actions to combat this crisis” that can reduce the number of new cases of addiction.

The FDA has just published a paper, FDA Facts: Abuse-Deterrent Opioid Medications, that details the agency’s strong support for abuse deterrence formulations. It says that opioids with abuse-deterrent properties are, as Gottlieb says, “not abuse-proof.” But the agency points out that they are “a step toward products that will help reduce abuse.”

The agency “fully supports efforts to better understand the impact of these products in the real-world setting and develop innovative formulations that have the potential to make abuse of these products more difficult or less rewarding,” the paper says. “The FDA is working with many drug makers to support advancements in this area and help drug makers navigate the regulatory path to market as quickly as possible. In working with industry, the FDA is taking a flexible, adaptive approach to the evaluation and labeling of potentially AD products.”

Here’s a list of the currently approved brand-name abuse-deterrent prescription opioids on the market. No generic versions have yet been approved for abuse-deterrent labeling:

The FDA has approved the following opioids with labeling describing AD properties consistent with the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling:

  • OxyContin – oxycodone, Purdue Pharma
  • Targiniq ER – oxycodone and naloxone, Purdue Pharma
  • Embeda – morphine and naltrexone, Pfizer Inc.
  • Hysingla ER – hydrocodone, Purdue Pharma
  • MorphaBond – morphine, Daiichi Sankyo, Inc.
  • Xtampza ER – oxycodone, Collegium Pharmaceutical Inc
  • Troxyca ER – oxycodone and naltrexone, Pfizer Inc.
  • Arymo ER – morphine, Egalet Corp.
  • Vantrela ER – hydrocodone, Teva Pharm.
  • RoxyBond  – oxycodone, Inspirion

We can certainly see the popularity of oxycodone – half of the 10 approved formulations are built around that drug. Three are morphine and two are hydrocodone. Three are designed with the antagonists naloxone or naltrexone, the rest with some sort of crush and dissolve resistance.

It does look like the FDA is working hard to be responsive to the opioid epidemic.  Meanwhile we are working hard to help those that want to end their dependency on opioids.

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In a surprise move that won't please Endo Pharmaceuticals, newly-appointed FDA Commissioner Dr. Scott Gottlieb says the agency is asking drugmaker Endo Pharmaceuticals to remove its opioid painkiller Opana ER (oxymorphone hydrochloride) from the market. "We are facing an opioid epidemic - a…

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reported on the devastation Opana ER was causing. We described the checkered history of Numorphan, Opana and oxymorphone, and how it now was causing a new wave of overdose deaths and the spread of HIV and Hep-C – possibly the worst outbreaks in over a decade. We told how Opana ER had become the favorite among prescription opioid injection abusers in Indiana and the Appalachian states.

Since then, some federal and state agencies have been working on it, but until now we haven’t heard from the FDA.

So when Scott Gottlieb took over the reins at the FDA a couple of weeks ago and announced that his major priority would be to do whatever the FDA can to combat the opioid epidemic, we crossed our fingers and hoped for the best.

Well, it appears that Gottlieb is a man of his word. We’re happy to see that one of the major players in diverted prescription opioids soon may be off the market – a market already glutted with far more opioid painkillers than are needed.

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Developer says the new drug reduces pain without creating the euphoria that led to the opioid epidemic Drug developer Nektar Therapeutics has announced positive results from a phase III trial of its experimental opioid painkiller called NKTR-181. The drug “significantly reduced pain in patients…

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A blockbuster investigative report in the Los Angeles Times recently says Purdue Pharma knew about illegal sales of its opioid painkiller OxyContin to Los Angeles drug dealers, and failed to report it to authorities. The highly addictive and potentially lethal painkiller OxyContin, essentially…

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Call to speak to one of our experienced & caring detox advisors today!

Close to a dozen abuse-deterrent prescription opioid painkillers have been approved by the FDA Panel over the past few years. Already this year, three more companies have submitted new opioid painkillers with abuse-deterrent formulation for approval. (Abuse deterrence means that the pills,…

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In its second move in a week aimed at beefing up regulations concerning the nation’s opioid addiction epidemic, the Food and Drug Administration (FDA) has introduced guidelines for the development of abuse-deterrent formulations for all approved generic oral prescription opioids. Earlier in…

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The FDA has said no-go to Purdue Pharma's plan to bring a new immediate-release oxycodone painkiller to market. But the same panelists have approved an extended-release oxycodone painkiller from Collegium Pharmaceutical. Purdue's new painkiller, to be called Avridi if approved, was planned as…

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Novus is the best way to get your life back as painlessly as possible.

Call to speak to one of our experienced & caring detox advisors today!

When the prescription opioid painkiller Numorphan in pill form was taken off the market 36 years ago in 1979, most people working in addiction treatment breathed a sigh of relief. Throughout the 1960s and ‘70s, Numorphan (generic name oxymorphone) was seen to be responsible for countless…

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