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news.Alkermes, a biotechnology company engaged in developing medicines to improve patients' lives, has started a multicenter, randomized, double-blind, placebo-controlled, parallel-group, multi-dose Phase 1/2 study to investigate ALKS 5461 for treatment-resistant depression (TRD).
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ALKS 5461 is the combination of ALKS 33 and buprenorphine.
The trial will evaluate the safety, efficacy and pharmacokinetics of ALKS 5461 in 32 patients who are suffering from TRD.
ALKS 5461 is designed to be a non-addictive, kappa antagonist for the treatment of TRD.
Preclinical research has demonstrated that kappa blockade has antidepressant effects in behavioral models of depression.
Alkermes chief medical officer Elliot Ehrich said the combination of ALKS 33 with buprenorphine to create ALKS 5461 leverages their expertise with opioid modulators and may create a non-addictive therapy for treatment-resistant depression.