FDA Places Opioid Alternative Pain Drug Study on Hold

FDA Places Opioid Alternative Pain Drug Study on Hold

by Staff

The experimental pain medication, fasinumab, developed by Teva Pharmaceuticals and Regeneron Pharmaceuticals, has been put on a clinical hold by the Food and Drug Administration due to safety concerns.

The drug was being tested in a Phase 2b clinical study as an alternative to opioids for people suffering with chronic back pain.  The FDA “requested an amendment of the study protocol after observing a case of adjudicated arthropathy in a patient receiving high dose fasinumab who had advanced osteoarthritis at study entry,” the companies noted in a press release.

Regeneron completed an unplanned interim review of results that showed “clear evidence of efficacy with improvement in pain scores in all fasinumab groups compared to placebo at the 8- and 12-week time points (nominal p-value less than 0.01).”

The companies said that preliminary safety results are generally consistent with what has been previously reported with the class.  The Phase 2b chronic low back pain study enrolled approximately 70 percent of the targeted 800 patients in four dose groups: placebo, 6mg subcutaneously monthly, 9mg subcutaneously monthly and 9mg intravenously every two months. Regeneron has notified health authorities and study investigators about the decision. Patients will continue to be followed for up to 36 weeks.

The companies plan to design a Phase 3 study in chronic low back pain that excludes patients with advanced osteoarthritis.  They plan to submit a pivotal program plan for review with the FDA and other health authorities.

“We are making data-driven decisions on Phase 3 fasinumab dosing that we believe will maximize potential benefit for patients in need, while minimizing the likelihood of side effects,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. “We look forward to working with global health authorities to advance this important investigational therapy for patients with often difficult-to-treat osteoarthritis pain and chronic low back pain.”

“We believe fasinumab represents an important potential innovation for patients with osteoarthritis pain and chronic low back pain who currently have clear unmet need and limited treatment options,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We look forward to advancing clinical development for this promising novel therapy.”

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Authored by: Staff

There are 4 comments for this article
  1. Sandra at 10:34 am

    I don’t think they will do this. I can see it really back firing in their face. I wish they would do this. Lol

  2. Jackie Melcher at 9:05 am

    More lives to ruin with greed and false advertising.

  3. HJ at 6:30 am

    I think this means this won’t be an option for me or for my mother. It’d be great if someone explained what “adjudicated arthropy” means. Translation?

    If it made arthritis worse, it’d be helpful if they had an idea of the mechanism that was involved. But, that wouldn’t earn them money. :/

  4. Jean Price at 6:27 am

    A nerve growth factor antibody…hmmmm. Wondering how this targets the specific nerves involved in the person’s pain…or just all nerves… since it’s delivery is either an injection into the subcutaneous skin layer or through an IV. Wonder also if it could be used in children whose growth stages weren’t yet complete. Lots of questions to be answered about this type of pain therapy, I’m sure. One article I read said the actual reason the trials were suspended was an incorrect diagnosis…but didn’t say what the real diagnosis was. (Something involving necrosis of a joint they had originally thought.). As new medication therapies are likely to come about, the risks versus staying with opioids has to be assessed…unless the plan is to get TOTALLY rid of opiates as a pain medication option. I would hope these studies also go into comparison studies where people receive opioids versus the experimental drug. But with this delivery system, it might be difficult to do that, since opioids for patients to take are in pill form, even the long acting ones. Without a comparison to opioids as a proven pain reliever, I wonder how they will assess the relief of the new drug appropriately, except in comparison to placebo. One thing for certain…there should be no shortage of those in pain willing to try anything to help!! Especially with the climate of denied medication happening now!!