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Categories: Opiates

Speaking to a National Press Club Luncheon in Washington, D.C., recently, FDA Commissioner Dr. Scott Gottlieb said, "We've watched over a 10 or 15 year period this epidemic grow in proportion. And even as we've tried to take measures to intervene in various ways, the epidemic was always 5 steps…

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withdraw Opana ER from the market, based on a new analysis of the risks associated with the drug’s illicit use. Opana ER, an extended release, tamper- or abuse-resistant formulation of the opioid oxymorphone hydrochloride, drove one the deadliest outbreaks of HIV/AIDS and Hepatitis C in a decade, along with overdose deaths, among addicts in Indiana.

Studies showed that the formulation, when abused and injected, released an excipient that caused autoimmune phenomena that contributed to the alarming spread of disease associated with its abuse. The drug was also more prone to injection than other abuse-resistant formulas in use today.

“I recently have seen media reports stating that Endo is participating in a re-launch of the old version of Opana ER,” Dr. Gottlieb said. “This is the version of that drug that Endo had previously withdrawn from the market when it launched its reformulated version of Opana – because that older version didn’t purport to have abuse deterrent features.”

The Commissioner said he wouldn’t speak about regulatory intentions regarding specific drugs, but that the agency will “address oxymorphone products more generally.” He said a study already commissioned is looking at the possibility that oxymorphone “is more likely to be abused than other Schedule II opioids, including through illicit routes of administration such as snorting and injection.”

“I’m announcing that study for the first time. If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, FDA would consider taking regulatory actions that could limit patient exposure to oxymorphone.”

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Categories: Legal, Opiates

A group of public health officials and doctors have filed a "Citizen Petition" with the Food and Drug Administration (FDA) asking the agency to remove ultra-high dosage unit (UHDU) opioid painkillers from the market. The petition specifically targets oral and transmucosal painkillers providing…

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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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President Trump's newly appointed FDA Commissioner, Scott Gottlieb, told his first gathering of agency staff last week that "unquestionably, our greatest immediate challenge is the problem of opioid abuse." Gottlieb said the opioid epidemic is "a public health crisis of staggering human and…

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

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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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After years of foot-dragging, the Food and Drug Administration (FDA) has finally decided to call for its most stringent “black box warnings” to be added to the labels of some 175 generic and brand-name opioid immediate-release (IR) prescription painkillers. The targeted drugs are among the…

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A few weeks ago we reported about new research showing that combining opioids with benzodiazepines carries a 4-times-higher risk of fatal overdose. Now we read in the Washington Post that “dozens of public health officials and academics across the country are pushing the Food and Drug…

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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!

In recent years, numerous Big Pharma companies have been fined hundreds of millions and even billions of dollars for "off-label marketing" - promoting uses for its drugs that have not been ruled "safe and effective" by the FDA. Restrictions on what drug companies can say to promote their products…

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The new White House Heroin Program Response Strategy is aimed at combating the national rise in heroin abuse by concentrating on regions of the country considered the most affected. The $13.4 million funding has been allocated to what are called "High Intensity Drug Trafficking Areas (HIDTA)." "Of…

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