Drugs

First Psychedelic NDA Filing Claimed for PTSD Therapy

MAPS Public Benefit Corp. has filed what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine capsules), for use in combination with psychological intervention for treating post-traumatic stress disorder (PTSD). Psychological intervention includes psychotherapy, talk therapy, or other supportive services provided by a qualified healthcare provider, according to the company.

The submission included results from “numerous” studies including two Phase 3 studies evaluating the efficacy and safety of the MDMA-assisted therapy versus placebo in participants diagnosed with moderate or moderate and severe PTSD, respectively. The MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine, the company says.

The primary endpoint was a measurement of change from baseline in clinician-administered PTSD Scale for DSM-5 and the key secondary endpoint was improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale, according to the company. “No serious adverse events were reported in the MDMA group in both studies,” it says.

MAPS says FDA had previously granted MDMA a breakthrough therapy designation, and it is now requesting a priority review for the submission, expecting an agency decision within 60 days.

MDMA is an entactogen, a class of psychoactive drugs that “produce experiences of emotional communion, oneness, relatedness, emotional openness and is thought to have use for various medical conditions,” MAPS says. Outside of the clinic, MDMA is known as the party drug ecstasy.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome