FDA Zeros In on Abuse-Deterrent Opioids

FDA Zeros In on Abuse-Deterrent Opioids

The FDA said it is not ready to banish non-abuse-deterrent opioid formulations from the market: “We have said that a class-wide requirement is not feasible or in the interests of public health at this time,” the agency wrote in a Federal Register notice.

It said it will continue to take a case-by-case approach to approval “with a goal of incentivizing an incremental, sponsor-driven market transition from conventional opioid formulations to formulations with meaningful abuse-deterrent properties.”

So far, only three opioid products on the market have approved abuse-deterrent labeling. Two of those, reformulated OxyContin (oxycodone) and Targiniq (oxycodone/naloxone), are from Purdue Pharma.

The other is from Pfizer, which won approval of abuse-deterrent Embeda, a combination of morphine and the opioid antagonist naltrexone, earlier this month.

In 2013, the FDA blocked generic versions of Purdue’s non-abuse-deterrent formulation of OxyContin, noting that the reformulation demonstrated efficacy in reducing abuse — allowing for the company to put abuse-deterrent labeling on the product.

Then in July, the FDA approved the company’s Targiniq that won abuse-deterrent labeling. Purdue, however, has not yet launched that product.

FDA has signaled that it is interested in the concerns of both branded and generic opioid manufacturers and held two separate conference calls in August asking each industry to select representatives to give presentations during both days of the meeting.

Only 1 month after FDA put the lid on OxyContin generics, the agency said Endo Pharmaceuticals’ reformulated Opana did not meet abuse-resistant criteria, and generic formulations of its original version were allowed on the market.

At that time, the agency said that these “seemingly paradoxical decisions were based on FDA’s determination that OxyContin was withdrawn by the manufacturer on the basis of safety concerns, whereas Opana was withdrawn for other, unspecified reasons.”

Pain Experts Say New Opioid Has ‘Enormous’ Potential – National Pain Report

An experimental opioid drug designed to alleviate acute pain without the risk of abuse or addiction has “enormous” potential to treat some types of chronic pain, according to pain management experts.

The injectable analgesic – which for now has clunky name CR845 – was developed by Cara Therapeutics (NASDAQ: CARA), a Connecticut biopharmaceutical company. The company recently released the results of human abuse liability studies of CR845 on recreational drug users — who gave it very low scores for drug “liking” and making them feel “high.”

Unlike other narcotics, CR845 doesn’t act on opioid receptors in the brain and central nervous system – which can cause side effects such as respiratory depression, nausea, vomiting, and the euphoria that can lead to abuse and addiction. Instead, CR845 acts on receptors in nerve endings – in what is known as the peripheral nervous system

Cara Therapeutics hopes to begin Phase III clinical studies on CR845 in early 2015. If those efficacy studies are successful and it gets FDA approval – which could take years – the drug is most likely to be used as an injectable analgesic to treat acute pain caused by injuries or surgery.

“Initially this is going to be hospital based, for emergency rooms or acute care. But if it is effective as an analgesic, because of the low abuse potential this would be an enormous opportunity to (use) a safer, more effective analgesic that would avoid some of the rewarding properties of the current opioids. I would hope they would develop it.”

it most likely won’t be effective treating spinal pain or other types of chronic pain that originate in the central nervous system.

But even if CR845 is only approved for acute pain, Twillman says it could be a major step forward in reducing the risk of opioid addiction

FDA Okays Third Abuse-Deterrent Opioid

Pfizer’s combination of morphine and naltrexone (Embeda) will be the third opioid painkiller to win the FDA’s abuse-deterrent label, the agency announced in a press release.

FDA said data have shown that the combination should reduce abuse when the drug is crushed and then eaten or snorted. When the tablet is crushed, the naltrexone — an opioid antagonist — blocks the euphoric effects of morphine.

The drug first came on the market in August 2009 but was voluntarily withdrawn in 2011 due to stability concerns. It came back on the market in November 2013, and can now add the abuse-deterrence claim.

A date for the release of the final guidance has not yet been set.  



5 thoughts on “FDA Zeros In on Abuse-Deterrent Opioids

  1. painkills2

    At first I thought CR845 was another Celebrex. Then, with a little more digging, I figured out we’re talking about another Suboxone.

    From Wikipedia page for “κ-opioid receptor”: “However, KOR agonists also produce side effects such as dysphoria and hallucinations, which limits their clinical usefulness.”

    I’m confused. Have these drugs been successful for anything other than the treatment of addiction (if that)? Because most of what I’ve read about this drug’s effectiveness to treat pain is not good (I’m talking about from actual patients, not studies). In fact, I am very interested in hearing from any patients who’ve taken these new biopharmaceutical concoctions.

    Additionally, I’ve read that these kinds of drugs are also part of the opioid abuse “epidemic.” I think the worst thing I’ve read about Naloxone was at Wikipedia: “Studies show that to give this to a person in severe pain would be unethical and inhumane.” (Yikes.)

    “We really need to find something that doesn’t have rewarding properties that doesn’t lead to addiction,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine, who was the lead investigator in initial studies of the drug.

    For 95% of chronic pain patients, we already have drugs that don’t lead to addiction. And it is within that “reward” effect where most pain relief is found. Regardless, most chronic pain patients don’t get “high,” so that’s not the reason that a very small percentage of us become addicted.

    What we’ve got here is a treatment for addiction, not pain. It just so happens that addiction causes pain — but most chronic pain patients are not suffering from that kind of pain.

    As for the percentage of the population who suffer from addiction at any given time, they will use whatever drugs are available and affordable — regardless of the sorcery of the biopharmaceutical industry. What, you think doctors and scientists know more about drugs than addicts?

    Ya’ll should be studying and researching endocannabinoids — that’s the future. If you’re against the psychoactive effect, then just look at CBDs other than THC — I think there are over 70 of them (so far).

    [I tried to post this comment at the National Pain Report website on its article for CR845 — twice. But my comment was censored and not posted. Since that’s the first time I’ve been censored on the National Pain Report website, I have to conclude that my comment touched a nerve. After all, who’s afraid of the truth? I’ve also concluded that the website is not really for pain patients — it appears to be a front for the investors involved with CR845. Therefore, I’ve unsubscribed to that website and will no longer be posting there. And I just thought pain patients should be aware of the truth behind the websites they are supporting.]


    1. Zyp Czyk Post author

      Interesting read! It seems that one opioid is just like another, no matter the specific kind, and people will use any one of them like they use their favorite: pain patients for pain, abusers for recreation, addicts to prevent withdrawal.

      Why can’t people accept that addiction is in the person, not the drug?


  2. Pingback: FDA Zeros In on Abuse-Deterrent Opioids | All Things Chronic

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