- Alkermes (NASDAQ:ALKS) has received a Refusal to File letter from the FDA regarding its marketing application seeking approval for ALKS 5461 for the adjunctive treatment of patients with major depressive disorder (MDD) who have not responded adequately ot standard antidepressant therapies.
- The agency indicated that the application was not complete enough to allow for a review. Specifically, the filing did not contain enough data to demonstrate overall effectiveness for the proposed indication and additional studies will be needed. Also, a bioavailability study to generate additional bridging data between ALKS 5461 and the reference drug buprenorphine will be required.
- The company says it disagrees with the FDA position and plans to appeal the rejection. CEO Richard Pops says, "We are extremely disappointed with this decision and the implications for patients in the U.S. suffering from major depressive disorder, a serious disease where there is a clear and urgent need for new treatment options for patients and their families. We strongly believe that the clinical development program, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461's consistent antidepressant activity and a favorable benefit-risk profile."
- Fast Track-tagged ALKS-5461 is a once-daily, orally administered formulation of samidorphan and buprenorphine that is designed to rebalance brain function that is dysregulated in the state of depression.
- Management will host a conference call this morning at 8:30 am ET to discuss the situation.
- Previously: Alkermes commences rolling NDA submission for MDD med ALKS 5461 (Aug. 21, 2017)
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