Alkermes recently announced study results that indicated efficacy and safety of ALKS 5461, a once-daily oral combination of samidorphan and buprenorphine, for major depressive disorder in individuals with inadequate response to antidepressants.
“ALKS 5461 embodies our dedication to developing novel and safe [central nervous system] medicines that address compelling unmet needs faced by large numbers of patients,” Richard Pops, BA, CEO of Alkermes, said in a press release. “Major depressive disorder affects millions of people and their families, and represents one of the greatest burdens of suffering and cost of any disease today. New drug development in the field is challenging and we are excited to advance ALKS 5461 in this important indication.”
To assess safety and efficacy of ALKS 5461, researchers conducted FORWARD-5, a phase 3, randomized, double-blind, multicenter, placebo-controlled sequential parallel comparison design study among 407 individuals with major depressive disorder (MDD) with inadequate response to a stable dose of selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Study participants were randomly assigned to receive 2 mg/2 mg or 1 mg/1 mg of ALKS 5461 as adjunctive treatment for MDD.
The 2 mg/2 mg dose of ALKS 5461 met the prespecified primary endpoint of significantly reducing depression scores, compared with placebo (P = .018).
Further, participants who received 2 mg/2 mg of ALKS 5461 exhibited statistically significant reductions in 10-item Montgomery–Åsberg Depression Rating Scale scores, compared with placebo (P = .026).
The 1 mg/1 mg dose of ALKS 5461 improved depressive symptoms but did not reach statistical significance.
The most common adverse events for ALKS 5461 were nausea, dizziness and fatigue.
Based on these findings, Alkermes plans to meet with the FDA’s Divison of Psychiatric Products to discuss filing ALKS 5461 for Fast Track Designation.
“We designed ALKS 5461 to have a novel mechanism of action for the treatment of MDD, a serious disease where new therapeutic options are highly sought after as millions of patients in the U.S. do not respond to standard courses of antidepressant therapy,” Elliot Ehrich, MD, chief medical officer of Alkermes, said in the release. “With the successful completion of the FORWARD-5 study and data from more than 1,500 patients to date, we have established a strong foundation of evidence of ALKS 5461’s clinical utility in the adjunctive treatment of major depressive disorder. With these data now in hand, we will move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS 5461, with a goal of bringing this important new medication to patients with MDD.”