Irish biotechnology firm Alkermes has received fast-track designation for its proprietary investigational medicine ALKS 5461 from the US Food and Drug Administration (FDA).
Fast-track designation was granted for the adjunctive treatment of patients with major depressive disorder (MDD) who don’t respond to standard therapies. The process intended to speed-up the review of drugs, which treat serious conditions and fill an unmet medical need.
Alkermes chief medical officer Elliot Ehrich said: "We are extremely pleased to have been conferred fast track status for ALKS 5461 as we believe that ALKS 5461 may represent an important option for the treatment of major depressive disorder."
ALKS 5461 is a once-daily, non-addictive medicine, which includes buprenorphine, a partial agonist, and ALKS 33, a potent mu-opioid antagonist, is currently under development for the treatment of major depressive disorder and cocaine addiction.
The mechanism of action for the medicine in the treatment of depressive symptoms is based on modulation of the opioid system in the brain, employing a balanced combination of agonism and antagonism of opioid receptors.
The National Institute on Drug Abuse provided funding for the early clinical development of the medicine.
Separately, the company completed its End-of-Phase II interactions with the FDA and also plans to advance ALKS 5461 into Phase III development in early 2014.
Previously, positive topline results from a Phase I/II study showed that ALKS 5461 was generally well tolerated.
Alkermes and FDA have also agreed on the preclinical and clinical requirements for the new drug application, the confirmatory study plans, the incorporation of new study designs that include the use of sequential parallel comparison design (SPCD), the primary endpoint and the statistical methodology.
According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), MDD is a condition that involves patients exhibiting depressive symptoms such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period.
