American Psychiatric Association

February 21, 2019 | Editorial Board | View Online | Psychiatric News

In This Issue

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INDUSTRY BRIEFS

Phase 3 Results for Investigational Insomnia Agent Suggest Efficacy

People with insomnia who take the investigational agent lemborexant may find themselves falling asleep faster and sleeping more soundly, according to data presented in February by Eisai Co. Ltd. and Purdue Pharma L.P.

As part of the phase 3 trial, 949 adults with insomnia disorder were randomized to lemborexant (5 mg or 10 mg) or placebo for six months. Participants were asked to keep electronic sleep diaries throughout the trial.

At the end of six months, patients who took lemborexant 5 mg reported falling asleep roughly 22 minutes faster on average than before, and those who took lemborexant 10 mg reported falling asleep roughly 28 minutes faster on average than before. Those who took placebo reported falling asleep roughly 12 minutes faster on average. Patients assigned to lemborexant also reported that they had slept better and had longer periods of sleep compared with those in the placebo group.

Lemborexant is thought to work by blunting wakefulness without impeding the ability to awaken in response to external stimuli.

FDA Nixes Alkermes’ Combo Drug for Depression

Earlier this month the Food and Drug Administration (FDA) rejected Alkermes’ new drug application for ALKS 5461, a combination pill containing samidorphan and buprenorphine intended for adjunctive treatment for major depressive disorder. According to a release issued by Alkermes, the FDA requested additional data to provide substantial evidence of the drug’s effectiveness.

The decision by the FDA to reject ALKS 5461 came months after an advisory panel recommended against approval of the medication. In an FDA briefing document, the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee described concerns over whether chronic exposure to the drug would increase the risk of opioid dependence, misuse, and abuse and whether it would be possible for individuals who want to misuse the buprenorphine component to chemically separate it from the samidorphan in the pills.

The company said it plans to meet with the FDA to discuss potential next steps for ALKS 5461.

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TEST YOUR KNOWLEDGE

Concomitant use of which of the following medications might be responsible for an increase in plasma clozapine levels in an adherent patient?

A. Carbamazepine.

B. Clonazepam.

C. Fluvoxamine.

D. Propranolol.

E. Temazepam.

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