Flexion Therapeutics’ Drug Trumps Saline for OA Pain Relief

Good news for OA patients and for Flexion Therapeutics, Inc.. The company is announcing that in the first of two pivotal clinical trials of its drug FX006 in patients with moderate to severe osteoarthritis (OA) knee pain, the drug made a difference. Specifically, 40 mg of FX006, compared to placebo (saline), demonstrated statistical significance in average pain relief over weeks 1 to 12 and over weeks 1 to 24. The company recently announced that the FDA has granted Fast Track designation for FX006.

According to the September 8, 2015 news release, “At weekly time points, 40 mg of FX006 also demonstrated superiority to placebo in pain relief beginning at week 1, continuing to week 11 and also at week 13. The primary endpoint of the trial, superiority in pain relief at 12 weeks, did not reach statistical significance. A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BLOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks. Overall, the 40 mg dose of FX006 performed better than the 20 mg FX006 dose. In particular, the 40 mg dose conferred more durable pain relief. The frequency of treatment-related adverse events across the three groups was comparable, and no drug-related serious adverse events were observed in the trial.”

Asked about the fast-track designation, Michael Clayman, M.D., Flexion Therapeutics’ President and CEO, told OTW, “There are two key elements that need to be demonstrated for a product to gain fast track designation. The first is that the disease that the product treats be considered a serious disease. Given the millions of patients with osteoarthritis of the knee, and the incredible toll it takes on individual patients and society alike, it seems apparent that condition is clearly met. The other condition is that the product demonstrates the potential to provide a significant advance over currently available therapies. Given the pain relief profile that FX006 has demonstrated to date, namely a rapid onset of action, a magnitude of pain relief that is among the greatest demonstrated in OA, and the extended duration of that relief, we believe this condition was readily met as well. So, in summary, it makes logical sense to us that FX006 was granted a fast-track designation.”

Clayman continued, “Based on current assumptions, by the end of next year we intend to have successfully completed our Phase III trial and submitted an NDA package for FX006 to the FDA.”