New Non-Opioid Pain Drug with Gets Mixed Clinical Trial Results: Stock Tumbles

New Non-Opioid Pain Drug with Gets Mixed Clinical Trial Results: Stock Tumbles

Cara Therapeutics, Inc. (Nasdaq: CARA) saw its stock plunge by nearly 40% (as of this writing) when its new non-opioid drug, oral CR845, received mixed results in its phase 2 clinical trial seeking to test its effectiveness in reducing chronic pain in people with osteoarthritis of the hip and knee.

The company tested three different dosages of CR845 – 1mg, 2.5mg and 5mg.  The 1mg and 2.5mg dosages failed to provide significant reductions in pain compared to placebo.  The 5mg dose did show statistically significant reduction in joint pain for those who specifically had osteoarthritis of the hip, but did not show reduction in joint pain for the combined knee and hip group.

In a press release, Cara Therapeutics’ Joseph Stauffer, D.O., M.B.A., Chief Medical Officer said, “We believe that the present trial of oral CR845 has highlighted the potential of a peripherally acting kappa agonist to provide clinical benefit in a chronic pain population and we’re pleased that statistical significance was achieved for the 5.0 mg dose in patients with OA of the hip.” “The drug was observed to be well tolerated over the treatment period and this overall data set will inform both our dose selection and patient population in designing our next trial of oral CR845 in OA patients.”

According to STAT News (a health, science and medicine publication), “Cara Therapeutics tried to misdirect investors away from the failure of its osteoarthritis pain pill by burying negative results from a mid-stage clinical trial in the middle of a press release issued Thursday night. The ploy didn’t work. Cara shares plunged.”

Wall Street is as tough on details, and pharmaceutical companies are tackling very tough problems.

“Developing effective analgesics that lack the high abuse potential and serious side effects of currently available drug classes remains the most pressing need in chronic pain,” said Dr. Ajay D. Wasan, M.D., M.Sc., Professor of Anesthesiology and Psychiatry, Vice Chair for Pain Medicine, Department of Anesthesiology, University of Pittsburgh Medical Center (UPMC). “The magnitude of the reduction in mean joint pain scores observed in all patients in this trial together with an encouraging safety profile underscores the significant potential of CR845 as a new therapeutic approach for the treatment of chronic inflammatory pain.”

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.

National Pain Report wrote about the early clinical data of an injectable version of CR845 in November of 2014, reporting, “Pain Experts Say New Opioid Has ‘Enormous’ Potential”.

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Authored by: Staff

There are 7 comments for this article
  1. Debbie at 6:12 am

    They need to leave ppl with chronic pain alone. They dont give a [edit] about us. We can go to the er when out sciatica has flared up and they give you fetynol. Wow that don’t work. GET REAL. Quit making us hurt for ya’lls sick excuse. You ppl don’t CARE

  2. Maureen at 9:10 pm

    Of course it didn’t work out well…opioids work the best for pain. We know…they ought to know it by now!

  3. scott michaels at 11:54 am

    Opioids work when talen as directed. My daughter juat had 4 wisdom teeth taken out. they gave her 12 norco pills 5/325. Her pain is brutal! they should have given her a 30 day supply of 10/325. on day 20. start wheening off. ny cutting them in half. by day 30 she sould be done and fine. These oral surgeons have no care of the pain and theyre afraid of the dea. THIS IS WRONG! BECAUSE 1 MORON IN 10000 WOULD MISUSE THE DRUG THE OTHER 9999 MUST SUFFER. WITH CHRONIC PAIN ITS EVEN WORSE. THAT PAIN NEVER WILL GO AWAY. THOSE PEOPLE ARE FORCED TO STOP TAKING A DRUG THAT WORKS OR HAVE A HUGE REDUCTION. AGAIN THE NUMBERS BECAUSE 20000 PEOPLE ABUSE OR MISUSE THE MEDICATION. 30,000,000 YES 30 MILLION MUST SUFFER. THOSE 20K ARE ADDICTS THAT WILL TURN TO HEROIN . THE 30 MILLION WILL SUFFER END THEIR LIVES AND A VERY VERY SMALL PORTION WILL TURN TO HEROIN. THESE ARE NOT ADDICTS. THESE ARE PEOPLE DEPENDENT OON OPIOIDS FOR PAIN RELIEF. NO MATTER WHAT THE DOSAGE, THEY DONT GET HIGH AND THEY WONT BREAK THE LAW.
    BUT NO THAT THE RULES CHANGED MID GAME FOR THESE GOOD PEOPLE WHO KNOWS. GRANDMA MIGHT TRY HEROIN. THE RULES WERE MADE TO SAVE INSURANCE COMPAINIES BILLIONS. THERE IS NO EPIDEMIC. THERE IS A MEDIA HYPE PUSHED BY STUPID POLITICIANS THAT HAVE NO PROBLEM GETTING PAIN PILLS WHEN NEEDED.
    THERE IS A HEROIN EPIDEMIC AND A SUICIDE EPIDEMIC ALL BECAUSE OF THE CDC GUIDELINES.
    NOW THE GOVT IS SUBSIDIZING THESE SNAKE OIL COMPANIES TO MAKE NON OPIOID PAIN RELIEVERS.
    STOCK DROPPED 40% in one day. THE CEO MADE HIS MILLIONS AS DID THE SO CALLED DOCTORS.
    FIGHT FOR YOUR RIGHT TO RELIEVE YOUR PAIN. WITHOUT BEING FORCED TO USE ILLEGAL DRUGS

  4. Kahty C at 8:31 am

    There is obviously ‘Fake News” and then there is this type of even more insidious misleading, Pharma Advertising. The use of the word “potential” is extremely misleading, a vague term that when used in a Headline, is deliberate deceptive.. They peddled this in the Stock Tips and Business Pages, and got Patient “Advocacy groups to reprint this “Fake News.” Credible Medical Sites, pushed this, and it went viral, due to the current ‘Epidemic” narrative. This Pharma Product is now part of the collective unconsciousness. They deceived the Public, disparaged Pain Patients, and they made money while they did it.
    The Thralls believe there are “Alternatives” which was probably the intention behind the premature publicity, along with the Profit motive. The people that promoted this clunker, most likely won’t be remembered. I don’t have much sympathy for the greedy Investors who though they could cash in on the “Deaths of Despair.” Here in the U.S any tragedy is a marketing and promotion opportunity. This ghoulish and despicable practice is just fine with people. The media will run this with an alternative explanation, after all it is “just business.” We can forget any Government Agency cracking down on Stock Manipulation or Fraudulent Practices. The Profiteers will be described as “Innovative.” The Journalists and Editors who pushed this “Fake News” will remain credible to their readers. We are truly in Post Fact, and Post Science America. At least this stuff did not make it to Market, it must have been really bad. If it had been only slightly better than Placebo, and it would have been foisted on the Public at 500 to 1000 per thirty day supply. The News Media, and Physicians already told the public there were alternatives. This led to an advertising frenzy for all kinds of Snake Oil, and New Age Practitioners. It is not about facts and truth anymore, it is about what people believe.

  5. William Dorn at 7:03 am

    This is more proof that opiute pain medicines are the only pain medicines that work.Used properly they are safe.Dont replace these medicines untill new medicines that really work are developed.Peoples lives are at stake.

  6. Tim Mason at 5:23 am

    These clinical trials should include the Gold Standard – an opioid along with their placebo.
    That way you have 1. Something that works, 2. Something that MIGHT work and 3. Something that is know to not work.
    Make sense?

  7. Debbie Oliver at 3:37 am

    I recently was evaluated for a knee OA clinical trial in Los Angeles. I had participated in a similar study 2 years ago at this very same research facility with good results. However, this time there was alot of focus on the kind of pain medication I was taking to manage my OA knee pain. The focus was on opiods. Since i do manage my pain with opiods I of course was completely honest about it. However the continuous questioning about this made me very uncomfortable as if I was being judged. This went on for 2 hours! They never once said this would disqualify me ! Im writing this to warn others who are interested in clinical trials that you may want to ask those facilities upfront about their policy on opiod pain management so you hopefully don’t havento go thru what I did.

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