Psychiatry in the News: February 2024

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

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

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

Positive Data on Oral Orexin Receptor 2 Agonist for Patients with Narcolepsy Type 1

Takeda announced positive topline results from a randomized, double-blind, placebo-controlled, multiple-dose phase 2b trial evaluating TAK-861, an oral orexin receptor 2 agonist, in patients with narcolepsy type 1.

“We are thrilled to announce these clear and compelling results from the TAK-861 trial in narcolepsy type 1 that allows us to rapidly initiate phase 3 trials this year as we work to deliver a medicine to patients that could address the underlying pathophysiology of the disease,” said Sarah Sheikh MSc, BM, BCh, MRCP, head of the Neuroscience Therapeutic Area Unit and Head for global development at Takeda. Continue Reading

HHS Announces $28 Million in Grant Funding for Substance Use Disorder Treatment Services

The US Department of Health and Human Services (HHS) has announced the launch of 2 grant programs through the Substance Abuse and Mental Health Services Administration (SAMHSA) intended to expand substance use disorder (SUD) treatment services.

These initiatives are specifically aimed at helping pregnant and postpartum individuals, as well as individuals involved in adult and family treatment drug courts. An estimated 5% of individuals consume 1 or more addictive substances during pregnancy, according to the National Institute on Drug Use, and the more than 4000 drug courts currently in operation are estimated to help reduce recidivism in participants by up to 40%. Continue Reading

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