Psychiatry in the News: March 2024

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Here’s some news you may have missed in the world of psychiatry from throughout the month of March, as featured in Psychiatric Times®.

Phase 3 Trial of AXS-12 for Narcolepsy Meets Primary Endpoint

The SYMPHONY phase 3 trial evaluating the efficacy of AXS-12 (reboxetine) for the treatment of narcolepsy has achieved positive results by meeting its primary endpoint. The trial revealed that AXS-12, a highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator that was granted Orphan Drug Designation for the treatment of narcolepsy in 2018, successfully met its primary endpoint by significantly reducing the frequency of cataplexy attacks in patients with narcolepsy compared with placebo.

“AXS-12 is a novel therapeutic approach to the treatment of narcolepsy as evidenced by the strong clinical results generated from the phase 3 SYMPHONY trial, including a rapid and significant reduction in cataplexy events compared to placebo,” said Michael Thorpy, MD, director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and professor of neurology at Albert Einstein College of Medicine, in a press release. Continue Reading

Phase 3 Antipsychotic Candidate Pimavanserin Fails to Achieve Primary Efficacy Endpoint

Recently released topline data from the phase 3 ADVANCE-2 trial reveals that the antipsychotic candidate pimavanserin did not achieve the primary efficacy endpoint of control of negative symptoms in patients with schizophrenia. Acadia Pharmaceuticals intends to discontinue research on pimavanserin for schizophrenia, following this failure.

"Treatments to improve the negative symptoms in schizophrenia, a large unmet need, remain elusive," said John J. Miller, MD, Editor in Chief of Psychiatric Times. "Pimavanserin (Nuplazid), an inverse serotonin 2A receptor agonist, failed to separate from placebo in a Phase 3 double-blind study of 454 adults with schizophrenia treated for 26 weeks. We will await ongoing clinical trials with drugs of different mechanisms of action in our continued attempt to develop a treatment to improve negative symptoms." Continue Reading

FDA Approves NeuroStar TMS for Treatment of MDD in Adolescents

NeuroStar Advanced Therapy has received clearance from the US Food and Drug Administration (FDA) as an adjunct in the treatment of major depressive disorder (MDD) in adolescent patients aged 15 to 21 years.

This clearance marks NeuroStar as the first and only transcranial magnetic stimulation (TMS) treatment that is FDA-cleared for this age group. MDD in adolescent patients is also the fourth FDA-cleared indication for NeuroStar, along with treatment of MDD in adults, treatment of obsessive-compulsive disorder in adults, and anxiety symptoms in adults with MDD. Continue Reading

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