Alkermes Initiates FORWARD-5 Clinical Study of ALKS 5461

Alkermes recently announced the initiation of FORWARD-5, the last remaining study of its three planned core efficacy studies in the pivotal clinical program for ALKS 5461 as an adjunctive treatment of major depressive disorder (MDD). The study will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have not responded satisfactorily to other commonly prescribed depression drugs, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

Following the positive results from Phase 1 and 2 trials of ALKS 5461, Alkermes started the Phase 3 trials in June with FORWARD-3 and  FORWARD-4. The recently started FORWARD-5 is a multinational, randomized, double-blind, placebo-controlled study which will evaluate ALKS 5461 in approximately 500 patients with MDD. Alkermes now has all three of the core efficacy studies in the FORWARD program underway, and the complete data from these studies is expected in 2016. Alkermes expects to use the safety and efficacy data from the FORWARD program as the basis for a New Drug Application (NDA) to be submitted to the FDA.

Elliot Ehrich, M.D., CMO of Alkermes, said, “We are very enthusiastic about our robust clinical program for ALKS 5461 as we evaluate the potential of its novel mechanism of action to treat MDD and offer a new option for the millions of people with unresolved depression.”

ALKS 5461 is a proprietary, once-daily, oral investigational medicine for the treatment of major depressive disorder (MDD). ALKS 5461 is the combination of ALKS 33 (Samidorphan, an oral opioid modulator) and buprenorphine, which is intended to be a non-addictive opioid modulator. ALKS 5461 acts as a balanced neuromodulator in the brain and has a novel mechanism of action for treating MDD.

As reported in Alkermes' press release, the FDA granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients who had an inadequate response to standard antidepressant therapies in October 2013. ALKS 5461 is also in clinical development for the treatment of cocaine addiction, funded through a grant from the National Institute on Drug Abuse (NIDA).

Major depressive disorder (MDD), also known as clinical depression, is a condition where patients exhibit severe depressive symptoms, such as 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. About16.1 million people in the U.S. suffer from MDD in a given year, and the prevalence rate is about 7 percent. About 60 percent of the individuals with clinical depression do not respond to initial antidepressant therapy. Thus, the new drug from Alkermes would have considerable impact if it successfully passes the clinical trials.

Alkermes now has several drugs in clinical trials for disorders such as multiple sclerosis,  schizophrenia, and other Central Nervous System (CNS) disorders.