Buprenorphine / samidorphan helpful in refractory depression
Maurizio Fava, M.D., from Harvard Medical School in Boston, and colleagues report on the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and inadequate response to ADT in two phase 3 randomized studies (FORWARD-4 and FORWARD-5). The Montgomery-Åsberg Depression Rating Scale (MADRS) was used to measure efficacy.
The researchers found that the primary end point was achieved in FORWARD-5; adjunctive BUP/SAM 2 mg/2 mg was demonstrated to be superior to placebo (average difference change from baseline to week three through end of treatment [EOT] in MADRS-6 and -10 versus placebo: −1.5 [P = 0018] and −1.9 [P = 0.026], respectively); the primary end point was not achieved in FORWARD-4 (change from baseline in MADRS-10 at week five versus placebo: −1.8; P = 0.109). In pooled analyses of the two studies, consistently greater reduction was seen in MADRS scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple time points, including EOT and average change from baseline to week three through EOT. For MADRS-10 change from baseline to EOT, the overall effect size in the pooled analyses was 0.22.
"Having a new class of antidepressants with a novel mechanism of action could have significant impact for patients with persistent symptoms," Fava said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Alkermes, manufacturer of ALKS 5461 (buprenorphine/samidorphan).
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