Buprenorphine/samidorphan (developmental code name ALKS-5461) is a combination drug formulation of buprenorphine and samidorphan acting as a κ-opioid receptor (KOR) antagonist which is under development by Alkermes as an adjunct to antidepressant therapy in treatment-resistant depression (TRD). It is also under investigation by Alkermes as a treatment for cocaine dependence, which is being funded by a grant from the National Institute on Drug Abuse (NIDA).
Clinical results with ALKS-5461 in Phase II have been described as "very encouraging", and researchers have stated that KOR antagonists including ALKS-5461 might work "extremely well for the treatment of major depression." However, data from two of three core Phase III trials was recently released and revealed that ALKS-5461 was safe and well-tolerated but, disappointingly, failed to meet its primary efficacy endpoints, although some efficacy was observed. The third and final core Phase III study is currently ongoing, with results expected sometime in 2016. As of March 2016, results of FORWARD-5 trial are reportedly expected by Q4 2016. Also, failures of endpoint efficacy goals in FORWARD 3 & 4 Phase III clinical trials; were analyzed and found to be unreliable based on a usually strong placebo effect. In addition, near-efficacious results were received using higher dosages only, indicating that ALKS-5641 will only be effective in higher than initially expected doses. No clinically relevant side effects were reported with the higher dosage trials.
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