<\/b><\/p>\n
<\/b><\/p>\n
TUESDAY, Nov. 6, 2018 (HealthDay News) — An adjunctive buprenorphine\/samidorphan (BUP\/SAM) combination seems beneficial for patients with major depressive disorder (MDD) with inadequate response to antidepressant therapy (ADT), according to a study published online Oct. 29 in Molecular Psychiatry<\/i>.<\/p>\n
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-\u00c5sberg Depression Rating Scale (MADRS) was used to measure efficacy.<\/p>\n
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: \u22121.5 [P = 0018] and \u22121.9 [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: \u22121.8; 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.<\/p>\n
“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.<\/p>\n
Several authors disclosed financial ties to pharmaceutical companies, including Alkermes, manufacturer of ALKS 5461 (buprenorphine\/samidorphan).<\/p>\n