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ALKS 5461 May Alleviate Major Depression Symptoms

Combination of Buprenorphine and Samidorphan Targets Opioid System Safely and Effectively

Fewer than 40 percent of patients with major depression respond well to traditional therapy with antidepressants. In two trials sponsored by Alkermes, Inc. (Waltham, Massachusetts), conducted at 111 sites in several countries, ALKS 5461 proved safe and effective when added to standard antidepressant treatment.

Buprenorphine—an opioid for both pain relief and treatment for opioid addiction—showed beneficial effects in low doses among patients with major depression. However, due to the risk of abuse and dependence, it has proved challenging to use it to treat depression. But combining buprenorphine with samidorphan blocks one of the opioid receptors activated by buprenorphine, reducing the potential for abuse and dependence that can occur when using the opioid alone.

At the end of both trials, participants receiving 2.0 mg doses of both active drugs showed a greater reduction in depression symptoms than did those receiving a placebo. Adverse effects including nausea, sleepiness, dizziness and fatigue were mild to moderate, usually lasting only several days.

Source: MedicalXpress.com, October 29, 2018

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Decision supported by data from more than 4,000 patients