The Week in Review: June 17-21

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This week, Psychiatric Times® discussed a wide variety of psychiatric issues and industry updates, from updates on lumateperone and psilocybin to an expert guide on tapering benzodiazepines.

Apex Labs Files IND Application for APEX-52 Study of Take-Home Microdose Psilocybin

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Apex Labs Ltd announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for APEX-002-B01-02, a study that will investigate the pharmacokinetics and driving performance related to the company’s APEX-52 take-home microdose psilocybin.

The study is set to be conducted at the Yale School of Medicine’s DrivSim Lab, utilizing the lab’s DSRI miniSim™ research driving simulator. Apex Labs, a pharmaceutical company focused on advancing mental health care through the use of psilocybin, will act as the study sponsor. Continue Reading

Lumateperone as an Adjunctive Therapy to Antidepressants: More Positive Results

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There are new positive topline results from Intra-Cellular Therapies’ study 502 evaluating lumateperone (Caplyta) 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints. This study—as well as the positive phase 3 trial, study 501—forms the basis for the lumateperone sNDA for the adjunctive treatment of MDD. The sNDA will be submitted to the US Food and Drug Administration (FDA) in the latter half of 2024.

“We are confident that the efficacy results from studies 501 and 502, along with the favorable safety and tolerability profiles from these studies, will make lumateperone a drug of choice for patients suffering with MDD who are having an inadequate response to antidepressant therapy,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies. Continue Reading

How to Safely and Effectively Taper Benzodiazepines

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Benzodiazepines, a controversial treatment widely prescribed for patients with anxiety and insomnia, carry a considerable risk of abuse. The poster “Mood Over Matter: Literature Review on Benzodiazepine Tapering, Current Practices and Updates on Adjunct Mood Stabilizers,” which was presented at the 2024 APA Annual Meeting, summarized a literature review of current benzodiazepine tapering practices, outpatient detoxification challenges, and potential barriers to discontinuation. The poster presenters also prioritized reviewing literature that highlighted mood stabilizer adjunct use.

Research demonstrates why clinicians should use caution when prescribing benzodiazepines. Results of a recent study revealed that between 2014 and 2016 an estimated 25.3 million (10.4%) adults in the United States reported using benzodiazepines, and approximately 17.2% of these individuals admitted to misuse. Continue Reading

Metformin, Inflammation, the Gut Microbiome, and Health Span: Connecting the Dots

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A recent article on the multiple uses of metformin brings up the important topic of repurposing medications. Repurposing has been around since the advent of modern medicine. One prominent example is the use of chlorpromazine (CPZ) as an antipsychotic.

Chlorpromazine was first synthesized in 1951 as a potentiator of general anesthesia. The psychiatric benefits were found later by Henri Laborit, a surgeon in the French army. He was doing research with artificial hibernation in prevention of surgical shock. Laborit employed the drug as an adjunct to anesthetics. He observed that CPZ at doses of 50 mg to 100 mg produced a lowering of body temperature, sedation, and disinterest without loss of consciousness. He was able to persuade his colleagues in the military hospital in Paris to try CPZ in the treatment of one of their patients who was experiencing psychotic agitation. Continue Reading

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