Psychiatry in the News: September 2023

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The US Food & Drug Administration (FDA) just announced the approval of gepirone hydrochloride extended-release tablets (Exxua), the first oral selective 5HT1A receptor agonist for the treatment of major depressive disorder in adults. Here’s more news you may have missed from the world of psychiatry throughout the month of September, as featured in Psychiatric Times®.

NDA Submitted for Investigational Muscarinic Antipsychotic in the Treatment of Schizophrenia

A New Drug Application (NDA) has been submitted to the US Food & Drug Administration (FDA) for an investigational muscarinic antipsychotic for the treatment of schizophrenia.

The NDA was submitted for investigational muscarinic antipsychotic, KarXT (xanomeline-trospium), which functions as a dual M1/M4 muscarinic acetylcholine receptor agonist within the central nervous system. Research suggests that this may mediate cognitive, positive, and negative symptoms of schizophrenia. The drug also does not block dopamine receptors directly, which differentiates it from existing treatments in this indication and positions the drug as a potential new approach to the treatment of schizophrenia. Continue Reading

Phase 3 Study Supports Efficacy, Safety of New Chemical Entity for MDD

Results from a long-term phase 3 study supported the efficacy and safety of a new chemical entity (NCE) for the treatment of major depressive disorder (MDD).

The study—a long-term, open-label, registrational, non-comparative trial known as Study 310—evaluated the safety and efficacy of REL-1017 administered once-daily in patients with MDD over a period of up to 1 year. In it, the investigators found that patients experienced fast, clinically meaningful, and sustained improvements in symptoms of depression and related functional impairment. They also found that REL-1017 was well-tolerated over the course of long-term dosing; noted low rates of adverse events and adverse event-related discontinuations; and detected no additional safety signals. Continue Reading

Topline Phase 2 Data Support Efficacy, Tolerability, and Favorable Safety of Treatment for PTSD

A phase 2a study of a treatment for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) found evidence of efficacy, tolerability, and favorable safety in its PTSD cohort.

The study—an ongoing, first-of-its-kind, 8-week, open-label, holdout dataset-controlled clinical trial in phase 2—aimed to find biologically based data for defining predictors and correlates of the effects of the drug, ALTO-100, in individuals with MDD and/or PTSD between the ages of 18 and 69 years. In the study, investigators measured improvements in symptoms of PTSD in a subgroup of 90 participants with primary PTSD using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), a 20-item structured interview for diagnosing and assessing PTSD symptoms that is considered the “gold standard” in PTSD assessment. Continue Reading

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