ALKS 5461 has already demonstrated efficacy versus placebo as an adjunctive major depressive disorder treatment in short-term randomized clinical trials. In a poster, researchers reported on the long-term efficacy, safety, and tolerability of the proposed therapy.
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ALKS 5461, a combined buprenorphine and samidorphan therapy, is a novel treatment for major depressive disorder (MDD) that is intended to address endogenous opioid dysregulation in the context of MDD. The investigational drug has already demonstrated efficacy versus placebo as an adjunctive MDD treatment in short-term randomized clinical trials, and in a poster presentation at the American Psychiatric Association 2018 Annual Meeting, researchers reported on the long-term efficacy, safety, and tolerability of the proposed therapy.
The ongoing, 12-month, open-label study, NCT02141399, included patients who had participated in 1 of 4 previous short-term studies as well as new patients, all of whom had confirmed diagnoses of MDD and a history of inadequate response to standard antidepressant therapies. Exclusion criteria included the use of opioid agonists within 14 days and a history of intolerance to buprenorphine or opioid antagonists. All patients (n = 1454) in the trial were treated with standard antidepressant therapy for at least 8 weeks prior to initiating treatment with the study drug.
Patients received sublingually administered ALKS 5461 as adjunctive treatment for up to 52 weeks. The trial’s primary efficacy measure was change from baseline in the Montgomery—Åsberg Depression Rating Scale (MADRS-10), and safety of the drug was assessed using adverse events (AEs), vital signs, laboratory analyses, and electrocardiography.
In total, 49% of patients completed the full year of study; 11% discontinued due to an AE. The researchers found that the mean MADRS-10 scores decreased from baseline, and that these decreases were maintained at the end of the study. The rate of patients achieving remission from their MDD was 52.5% at 12 months.
The most commonly reported AEs were nausea, headache, constipation, dizziness, and somnolence, and the study drug was not associated with any changes in laboratory or metabolic parameters, or with a change in body weight. No evidence of withdrawal at the time of treatment discontinuation was observed.
Overall, said the investigators, ALKS 5461 showed a durable antidepressant effect up to 52 weeks in patients with MDD, and the study drug was well tolerated, with an AE profile consistent with that reported in short-term trials.
Thase ME, Stanford AD, Memisoglu A, et al. Long-term efficacy, safety, and tolerability of adjunctive ALKS 5461 in patients with major depressive disorder enrolled in an ongoing phase 3 study. Presented at the American Psychiatric Association 2018 meeting, May 8, 2018; New York, New York. Abstract #P8-048.