US health regulator rejects MDMA treatment for PTSD, for now

US health regulator rejects MDMA treatment for PTSD, for now

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US health regulators on Friday denied an utility for treating put up-demanding stress disorder (PTSD) with the drug MDMA, recurrently identified as ecstasy, pronouncing extra investigation wished to be carried out.

The firm that submitted the utility, Lykos Therapeutics, talked about in a statement that the Meals and Drug Administration (FDA) had requested an additional Section 3 clinical trial to stare MDMA’s “security and efficacy.”

A panel of consultants convened by the FDA to grab into narrative clinical recordsdata on MDMA had overwhelmingly voted in early June to boom there became insufficient proof to utter it became efficient.

Whereas unsurprising, the decision announced Friday represents a blow to advocates of the radical treatment.

“The FDA question of for some other stare is deeply disappointing, now not correct for all those who dedicated their lives to this pioneering effort, but mostly for the thousands and thousands of American citizens with PTSD… who be pleased now not viewed any contemporary treatment choices in over two an extended time, talked about Lykos CEO Amy Emerson.

PTSD is a debilitating mental health condition that develops after a person experiences or is threatened by demanding events akin to loss of life, fight or sexual assault.

It affects an estimated 5 percent of American citizens in any given 365 days.

Pharmaceutical treatment choices for PTSD are to this point little to 2 antidepressants that require three months of dosing to grab close, and response rates to the medicines had been found to be uneven.

MDMA—methylenedioxymethamphetamine—is a Time table 1 drug under the Managed Substances Act, and approving it for medical use would be pleased represented a prime shift.

California-based mostly mostly Lykos based mostly mostly its question of for regulatory approval on two clinical analysis, every of which enrolled around 100 of us, to grab into narrative MDMA old in conjunction with assorted psychological interventions akin to discuss therapy, towards a placebo with discuss therapy.

These two analysis, published within the accepted journal Nature Medication, indicated MDMA became indeed both safe and highly efficient at treating PTSD.

But nine out of 11 consultants on the FDA panel talked about on hand recordsdata became now not sufficient to utter the treatment became efficient, and 10 out of 11 talked about the advantages did now not outweigh the hazards.

In a briefing doc attach together earlier than the meeting, FDA team raised issues about Lykos’s clinical trial methodology and criticized the firm for now not gathering sufficient side close recordsdata.

The firm talked about this is in a position to presumably well “work diligently within the coming months to take care of FDA’s issues and to grab serve of company processes to resolve scientific disagreements.”

“We intend to work tirelessly and use all on hand regulatory pathways to search out an inexpensive and expeditious direction forward,” Emerson added.

© 2024 AFP

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US health regulator rejects MDMA treatment for PTSD, for now (2024, August 10)
retrieved 10 August 2024
from https://medicalxpress.com/recordsdata/2024-08-health-mdma-treatment-ptsd.html

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