The Week in Review: February 12-16

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This week, Psychiatric Times® discussed a wide variety of psychiatric issues and industry updates, from psychotherapy vs pharmacotherapy for depression in heart failure to an update on the 2024 medication pipeline for antidepressants and ADHD treatments.

FDA Accepts, Grants Priority Review of NDA for MDMA-Assisted Therapy for PTSD

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The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for midomafetamine capsules (MDMA) intended for use in combination with psychological intervention for individuals with posttraumatic stress disorder (PTSD). The FDA has also granted priority review status to the application, setting a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. If approved, this will mark the first instance of MDMA-assisted therapy and psychedelic-assisted therapy.

Priority review status is granted by the FDA for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared with standard applications. Continue Reading

Drug for Agitation in Alzheimer Disease Dementia Fails in Phase 3 Trial

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Otsuka announce topline results of the phase 3 clinical trial of AVP-786, a combination of dextromethorphan hydrobromide and quinidine sulfate, in the treatment of agitation associated with Alzheimer disease dementia (NCT03393520). A statistically significant difference was not achieved on the primary efficacy endpoint, which was mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score compared with placebo.

“While the result of this trial is disappointing, we plan to analyze the full data set to determine the future potential of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease. In 2023, Otsuka became the first company to get a drug approved for this patient population and we are committed to expanding and innovating in this area,” said John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka. Continue Reading

Psychotherapy vs Pharmacotherapy for Depression in Heart Failure

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Data from a 1-year randomized trial showed that behavioral activation (BA) psychotherapy was comparable to antidepressant medication in relieving symptoms of depression in patients with heart failure. The psychotherapy group, however, demonstrated slightly more improvement in physical health-related quality of life (HRQOL), and had fewer emergency department (ED) visits and days of hospitalization.

“We postulated that the advantage of BA patients in improved physical-HRQOL, fewer ED visits and days of hospitalization might reflect the increased overall activation, motivation and self-care as a result of BA,” lead study author Waguih IsHak, MD, Department of Psychiatry and Behavioral Neurosciences, Cedars-Sinai Medical Center, Los Angeles, CA, told Psychiatric Times. Continue Reading

Medication Pipeline: Antidepressants and ADHD Rx

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In this second part of a 2-part series reviewing novel agents in the psychiatric pipeline, the focus is on treatments for unipolar major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). In last month’s part 1, we reviewed the pipeline for novel agents that have the potential to broaden our armamentarium for the treatment of all 3 symptom domains in schizophrenia—the positive, negative, and cognitive symptom clusters—as well as the long-awaited submission for US Food and Drug Administration (FDA) approval of 3,4-methylenedioxymethamphetamine (MDMA)–assisted therapy for posttraumatic stress disorder (PTSD).

Three brain receptors associated with depression may soon see novel agents to expand our current large armamentarium of treatments for MDD: the N-methyl-D-aspartate (NMDA) glutamate receptor, opioid κ receptor (κ-receptor), and serotonin 5-HT_2A receptor. MDD continues to challenge even the most skilled clinicians. Continue Reading

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