American Psychiatric Association

March 28, 2019 | Editorial Board | View Online | Psychiatric News

In This Issue

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INDUSTRY BRIEFS

FDA Approves ADHD Drug Adhansia HR

The Food and Drug Administration (FDA) in February approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. Adhansia XR is a central nervous system stimulant by Adlon Therapeutics L.P.

Four clinical studies evaluated the efficacy and safety of Adhansia XR in patients with ADHD: two clinical studies in adults, one analog classroom trial in patients aged 6 to 12 years, and one safety and efficacy study in patients aged 12 to 17 years. Patients in all studies achieved statistically significant improvement in symptoms while receiving Adhansia XR compared with placebo.

Adhansia XR will be available in six capsule strengths: 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg. The recommended starting dose for patients 6 years and older is 25 mg once daily, with titration in increments of 10 mg to 15 mg at intervals of no less than five days.

Rapastinel Fails Phase 3 Trials

In March Allergan announced that a series of phase 3 studies of rapastinel as an adjunctive treatment for treatment-resistant major depressive disorder (MDD) did not meet their primary endpoints.

In two studies totaling 872 patients with MDD who had not responded adequately to an oral antidepressant, participants were randomized to 450 mg of rapastinel or placebo given once weekly as a bolus intravenous injection in addition to their oral antidepressant. A third study using a similar design of 638 participants included a third treatment arm of 225 mg rapastinel weekly. The primary endpoint for all three studies was the change in scores on the Montgomery-Åsberg Depression Rating Scale from baseline at the end of three weeks. In all three trials, scores for patients receiving rapastinel did not significantly differ from those of the patients on placebo.

Allergan is conducting a global phase 3 trial to evaluate rapastinel’s efficacy, safety, and tolerability as a monotherapy for MDD compared with placebo. It is also conducting a phase 2 proof-of-concept study evaluating efficacy, safety, and tolerability of rapastinel compared with placebo in addition to standard of care for patients with MDD at imminent risk of suicide.

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TEST YOUR KNOWLEDGE

Which of the following statements about the psychopharmacological treatment of insomnia or disturbed sleep in individuals with a neurocognitive disorder is true?

A. Conventional hypnotics are generally avoided because of their tendency to increase irritability and agitation.

B. Conventional hypnotics are not recommended because they often exacerbate sleep-wake dysregulation.

C. Mood stabilizers should be first-line treatment for insomnia in persons with a neurocognitive disorder.

D. The rapid eye movement (REM) sleep behavior disorder that is a frequent concomitant to Lewy body disease often responds to treatment with hypnotics such as trazodone.

E. The REM sleep behavior disorder that is a frequent concomitant to Lewy body disease often responds to anticholinesterase treatment.

Click Here to Answer

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