Soliciting marketing approval for a medication addressing major depressive disorder (MDD), Alkermes PLC recently began a rolling submission of a New Drug Application (NDA) regarding its ALKS 5461 product, expecting completion by the end of 2017.
ALKS 5461 contains a combination of buprenorphine and samidorphan. The once-a-day oral formulation is designated for fast tracking to hasten its review as a potential treatment for serious conditions and unmet needs by the U.S. Food and Drug Administration, according to Alkermes spokespersons.
“The initiation of the rolling submission for ALKS 5461 is an important first step in the registration process for ALKS 5461, as we work to bring this potential new medicine to patients suffering from major depressive disorder,” Dr. Elliot Ehrich, executive vice president for research and development at Alkermes, said.
Fast-track status enables submitting companies to deliver portions of the NDA as completed on a rolling basis rather than adhering to one main deadline. Additionally, fast-track status improves a product’s eligibility for priority review.
“ALKS 5461 represents a novel mechanism of action for the treatment of MDD, a condition for which millions of patients in the U.S. do not achieve an adequate response to standard antidepressant therapies,” Ehrich said. “We … will continue to collaborate closely with the FDA [to make] ALKS 5461 available to patients and their health care providers.”