The NDA is based on data from more than 30 clinical trials involving ≥1500 patients with MDD.
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.
Enjoying our content?
Thanks for visiting Psychiatry Advisor. We hope you’re enjoying the latest clinical news, full-length features, case studies, and more.
You’ve viewed {{metering-count}} of {{metering-total}} articles this month. If you wish to read unlimited content, please log in or register below. Registration is free.
{{login-button}} {{register-button}}
Log in to continue reading this article.
Don’t miss out on today’s top content on Psychiatry Advisor. Register for free and gain unlimited access to:
- Clinical News, with personalized daily picks for you
- Evidence-Based Guidance
- Conference Coverage
- Unique Psychiatry Case Studies
- Full-Length Features
- Drug Monographs
- And More
{{login-button}} {{register-button}}
Want to read more?
Please login or register first to view this content.