The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461 (Alkermes) for the adjunctive treatment of major depressive disorder (MDD) in patients with inadequate response to standard therapies.
ALKS 5461 is a once-daily, oral medicine that acts as an opioid system modulator. It consists of a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.
The NDA is based on data from more than 30 clinical trials involving >1500 patients with MDD. “We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients,” said Craig Hopkinson, MD, CMO and SVP of Medicines Development and Medical Affairs at Alkermes.
The FDA has set a target action date of January 31, 2019, for the ALKS 5461 NDA decision.
For more information visit Alkermes.com.