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.”