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Medicine

FDA Approves Drug To Treat Pain Without Opioid Effects (apnews.com) 20

Bruce66423 shares a report from the Associated Press: Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications such as Vicodin and OxyContin. "It's the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to opioids and over-the-counter medications such as ibuprofen and acetaminophen. But the medication's modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.

Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill. "It's not a slam dunk on effectiveness," said Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research. "But it is a slam dunk in that it's a very different pathway and mechanism of action. So, I think that shows a lot promise." The new drug will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less. [...]

Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. Those chemical interactions also give rise to opioids' addictive effects. Vertex's drug works differently, blocking proteins that trigger pain signals that are later sent to the brain. "In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain," Vertex's Dr. David Altshuler, told The Associated Press last year. Commonly reported side effects with the drug were nausea, constipation, itching, rash and headache.

FDA Approves Drug To Treat Pain Without Opioid Effects

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  • Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertexâ(TM)s drug provided more relief than a dummy pill but didnâ(TM)t outperform a common opioid-acetaminophen combination pill.

    Wait, it outperformed a tic-tac? I am sold, gimme two of them!

    • Can somebody loan me thirty bucks?

    • "Common opioid-acetaminophen combination pill" could mean Norcos or Tylenol 3s (acetaminophen plus either codeine or hydrocodone). You think those are like tic-tacs? This is damn good news if they found something that is equally effective and non-addictive. And since it's a novel mechanism of action, the efficacy might improve with the next generation.

      • Apparently, they found it to be about as effective as Tylenol 3. It uses a different mechanism than opioids to block pain, so the mechanism that causes opioid addiction should not be active. It remains to be seen how addictive it might be in long term use. Looking at the structure (https://en.wikipedia.org/wiki/Suzetrigine), I am not surprised at the price. This is not a cheap or easy molecule to make.
  • by ArchieBunker ( 132337 ) on Friday January 31, 2025 @10:47PM (#65134147)

    Cannabis is still a schedule 1 substance.

  • by sound+vision ( 884283 ) on Friday January 31, 2025 @10:49PM (#65134155) Journal

    For some perspective, $15/tablet is roughly the street price of Vicodin. Or the per-hit price of heroin, both opiates. Although the "heroin" available now is mostly fentanyl. (So is the Vicodin, unless you get it directly from a pharmacy.)

    The article didn't tell me anything about how the new meds work. It did mention side-effects of "nausea, constipation, itching" - these sound suspiciously similar to opiate side-effects, the last 2 in particular are fairly unique to opiates.

    The summary calls these new meds "non-abusable", but that's the same thing the industry said when OxyContin was released, and gabapentin. You must excuse me if I don't take these assertions at face value.

    • Oxycontin was never claimed to be non-abusable because of its chemical formula, only by its time-release formulation. But people easily found ways to circumvent that. So this new claim is of a different nature.
    • Anything that stops pain is going to be addictive... no one will want to stop if it means being in pain... and other than that, how does one define addictive?

      Addiction is simply something someone else refuses to stop doing... so this will be addictive regardless of what they think any specific mechanism is that causes addiction.

  • they'll find it is addictive after all, but they will have made billions by then so who cares

    (Of course WHO are no longer involved since Trump kicked them out.)

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