Flexion Announces New Drug Application For Zilretta (FX006) Accepted By U.S. FDA
? FDA Reviewing Zilretta as Potential New Treatment for Osteoarthritis of the Knee
? Assigns PDUFA date of October 6, 2017
BURLINGTON, Mass., Feb. 07, 2017 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its lead investigational product candidate Zilretta (also known as FX006). Zilretta is being evaluated as a new treatment option for patients with osteoarthritis (OA) of the knee. In accordance with the FDA's standard 10-month review designation, the agency has established a user fee goal date under the Prescription Drug User Fee Act (PDUFA) of October 6, 2017.
"The FDA's acceptance of the NDA for Zilretta is a seminal milestone for Flexion and encouraging news for the many millions of people who are confronting OA of the knee," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. "The pain associated with OA of the knee can be debilitating, and we believe that, if approved, Zilretta could serve as an important new treatment option for patients suffering from this progressive condition."
The Zilretta NDA for OA of the knee is supported by previously reported results from a pivotal Phase 3 clinical trial. The randomized, double blind, placebo and active-comparator (immediate-release triamcinolone acetonide (TA)) controlled trial enrolled 484 patients at 37 centers worldwide. Data from the trial showed that Zilretta demonstrated a highly significant (p<0.0001) reduction in average daily pain versus placebo at week 12 (primary endpoint), with durable and clinically meaningful pain relief in patients with moderate to severe OA knee pain. In addition, analyses of a number of OA-specific secondary endpoints such as WOMAC A[1] (pain), WOMAC B (stiffness) and WOMAC C (function), showed encouraging results favoring Zilretta compared to both placebo and immediate-release TA. The frequency of treatment-related side effects was comparable across all treatment arms in the trial. The most common adverse events for Zilretta with an incidence greater than 2% were arthralgia, headache, joint swelling and back pain. No drug-related serious adverse events were observed and no patients treated with Zilretta were discontinued from the study due to a treatment-related side effect.
? Assigns PDUFA date of October 6, 2017
BURLINGTON, Mass., Feb. 07, 2017 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its lead investigational product candidate Zilretta (also known as FX006). Zilretta is being evaluated as a new treatment option for patients with osteoarthritis (OA) of the knee. In accordance with the FDA's standard 10-month review designation, the agency has established a user fee goal date under the Prescription Drug User Fee Act (PDUFA) of October 6, 2017.
"The FDA's acceptance of the NDA for Zilretta is a seminal milestone for Flexion and encouraging news for the many millions of people who are confronting OA of the knee," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. "The pain associated with OA of the knee can be debilitating, and we believe that, if approved, Zilretta could serve as an important new treatment option for patients suffering from this progressive condition."
The Zilretta NDA for OA of the knee is supported by previously reported results from a pivotal Phase 3 clinical trial. The randomized, double blind, placebo and active-comparator (immediate-release triamcinolone acetonide (TA)) controlled trial enrolled 484 patients at 37 centers worldwide. Data from the trial showed that Zilretta demonstrated a highly significant (p<0.0001) reduction in average daily pain versus placebo at week 12 (primary endpoint), with durable and clinically meaningful pain relief in patients with moderate to severe OA knee pain. In addition, analyses of a number of OA-specific secondary endpoints such as WOMAC A[1] (pain), WOMAC B (stiffness) and WOMAC C (function), showed encouraging results favoring Zilretta compared to both placebo and immediate-release TA. The frequency of treatment-related side effects was comparable across all treatment arms in the trial. The most common adverse events for Zilretta with an incidence greater than 2% were arthralgia, headache, joint swelling and back pain. No drug-related serious adverse events were observed and no patients treated with Zilretta were discontinued from the study due to a treatment-related side effect.