Alkermes briefly falls, rebounds after announcing CRL for ALKS 5461

After the market close on February 1, Alkermes (ALKS) announced it received a Complete Response Letter, or CRL, from the FDA regarding its New Drug Application, or NDA, for ALKS 5461 for the adjunctive treatment of major depressive disorder, or MDD. FDA COMPLETE RESPONSE LETTER: The CRL stated that the FDA was unable to approve the ALKS 5461 NDA in its present form, and was requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD. Alkermes said it plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the FDA will inform whether there is a viable path forward for the ALKS 5461 program. The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. ALKS 5461: ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of MDD, in patients with an inadequate response to standard antidepressant therapies. An estimated 16.2M people in the U.S. suffered from MDD in 2016, the majority of whom may not adequately respond to initial antidepressant therapy. CRL EXPECTED BY ALKERMES CEO: On January 8, Alkermes CEO Richard Pops, during a breakout session at the JPMorgan Healthcare Conference, said his company expected the FDA to issue a Complete Response Letter for its depression candidate ALKS 5461. PRICE ACTION: After initially falling 10% in reaction to the news after-hours, shares of Alkermes are little changed, down 0.2% to $33.08

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