Alkermes plc has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

The NDA submission is based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD. ALKS 5461 was granted Fast Track status by the FDA in October 2013 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.

"ALKS 5461 represents the first potential treatment option with a novel mechanism of action for the treatment of depression in 30 years. We believe its unique pharmacology may provide distinct clinical benefits for the large number of patients who do not get adequate relief from first-line standard antidepressant therapy," stated Elliot Ehrich, M.D., Executive Vice President, Research and Development at Alkermes. "With this regulatory submission, we are one step closer to our goal of bringing this important new medicine to patients, families and healthcare professionals, who are eager for new treatment options."

"ALKS 5461 has demonstrated consistent safety, tolerability and antidepressant activity for the adjunctive treatment of major depressive disorder throughout its comprehensive clinical development program," stated Craig Hopkinson, M.D., icer and ident, Clinical Development and Medical Affairs at Alkermes. "The NDA submission of ALKS 5461 further demonstrates our ongoing commitment to developing innovative, patient-centered treatment options for those afflicted by serious mental illness and chronic CNS disorders."

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 major depressive disorder (MDD). ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist. In October 2013, the FDA granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.

According to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), major depressive disorder (MDD) is a condition in which patients exhibit 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, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 17 million people in the US suffer from MDD in a given year,1,2 the majority of whom may not adequately respond to initial antidepressant therapy.