The Week in Review: May 20-24

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This week, Psychiatric Times® discussed a wide variety of psychiatric issues and industry updates, from new data on a treatment for tardive dyskinesia to an update on psychotropic polypharmacy trends among child and adolescent Medicaid beneficiaries.

FDA Clears Cingulate to File NDA for CTx-1301 in the Treatment of ADHD

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Cingulate Inc has announced alignment with the US Food and Drug Administration (FDA) on the requirements for filing a New Drug Application (NDA) for its lead candidate, CTx-1301 (dexmethylphenidate). This medication is intended for the treatment of attention-deficit /hyperactivity disorder (ADHD) in patients aged 6 years and older.

“We are pleased with the FDA’s guidance and perspective regarding our pathway to a timely NDA filing, and we will proceed to complete all remaining requirements accordingly,” said Shane J. Schaffer, Cingulate chairman and CEO, in a press release. “We also believe this communication provides additional go-to-market momentum as we continue to meet with potential partners for the outlicensing of CTx-1301 in the United States and abroad.” Continue Reading

Weight-Adjusted Waist Index and Depressive Symptoms in a Nationally Representative Sample

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Depression is the leading cause of disability worldwide. Obesity is a replicated risk factor for the onset of depressive symptoms, with a magnitude of >50%. Conventional measures of obesity include BMI and waist circumference (WC). However, BMI does not distinguish between visceral fat and muscle mass; similarly, WC does not distinguish between visceral and subcutaneous fat.

Weight-adjusted waist index (WWI) has been proposed as a new index of obesity reflecting central obesity, which standardizes WC to better reflect adiposity and muscularity. However, the relationship between WWI and depressive symptoms is unknown. Continue Reading

Psychotropic Polypharmacy Trends Rise Among Child, Adolescent Medicaid Beneficiaries

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The results of a study examining trends in psychotropic polypharmacy among youths enrolled in Medicaid indicated that there has been a rise in the concomitant use of multiple psychotropic medications in this patient population.

According to the study’s investigators, psychotropic polypharmacy—which refers to the concurrent use of medications for attention-deficit/hyperactivity disorder, antipsychotics, mood-stabilizing anticonvulsants, and antidepressants—has raised safety concerns over the past 2 decades, as it increases the risk of adverse medical outcomes. Continue Reading

Managing Tardive Dyskinesia: New Data from Phase 3 Study of Ingrezza

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New data from a post hoc analysis of Neurocrine Biosciences’ phase 3 KINECT®-4 study of Ingrezza (valbenazine) capsules, which assessed long-term outcomes for the management of tardive dyskinesia (TD), demonstrated that almost all study participants saw clinically meaningful improvements in TD symptom severity by week 48.

“TD is a persistent, debilitating disorder requiring continuous treatment to effectively and sustainably improve symptoms over time," said Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences. “This post hoc analysis, along with previous long-term analyses, demonstrate the reliable, long-term efficacy and tolerability of one-capsule, once-daily Ingrezza to help inform use of this treatment in clinical practice.” Continue Reading

See more recent coverage from Psychiatric Times here. And be sure to stay up-to-date by subscribing to the Psychiatric Times E-newsletter.

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