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MDMA’s potential shift from party drug to PTSD therapy could hinge on strict safety measures

MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks.

On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress disorder, based on positive phase 3 results demonstrating significant PTSD reductions for most trial participants. In the studies, a significant number of those receiving MDMA-assisted therapy no longer qualified for a PTSD diagnosis after three treatment sessions, with a large majority seeing clinically meaningful improvements.

Currently, the Drug Enforcement Administration (DEA) categorizes MDMA as a Schedule I controlled substance having no approved medical uses, although it is likely to reclassify the stimulant if it receives FDA approval.

MAPS founder Ric…

A century after its synthesis, MDMA could be headed for FDA approval for PTSD

First synthesized in 1912 by Merck, the empathogenic drug 3,4-Methylenedioxymethamphetamine (MDMA) is inching toward FDA approval following the positive results of a phase 3 study. The recently concluded phase 3 study, MAPP2, published in Nature Medicine, found that MDMA-assisted therapy significantly outperforms traditional talk therapy in reducing PTSD symptoms. Participants receiving MDMA-AT had an 86.5% response rate (≥10-point reduction in PTSD symptoms), compared to a 69.0% response rate among participants receiving therapy with placebo. Equally impressive, 71.2% of the MDMA-AT participants no longer met the PTSD criteria post-treatment, in contrast to the 47.6% in the placebo with therapy group. At the close of the trial, 46.2% of the MDMA-AT participants met the remission criteria in contrast to the 21.4% in the placebo with therapy group.

MDMA’s efficacy in PTSD treatment // Load the Visualization API and the corechart package. google.char…

MAPS predicts FDA approval for MDMA-assisted therapy in 2024

The Multidisciplinary Association for Psychedelic Studies (MAPS) founder and executive director, Rick Doblin, said in an interview with Fox Business Live that the FDA would approve MDMA-assisted therapy for PTSD in April or May of 2024.

Last year, MAPS announced the completion of the MAPP2 Phase 3 study, which is the organization’s second to use MDMA (3,4-methylenedioxymethamphetamine) therapy for PTSD treatment. The organization anticipates releasing data from the study in the first quarter of 2023.

In the Fox interview, Doblin said that the MAPP2 study achieved confirmatory results for treating PTSD.

Doblin underscored the importance of therapy in the Phase 3 trial. “It’s the therapy that is the primary active treatment, and the MDMA, the medicine, makes the therapy more effective,” he said in the interview.

He also noted that the Veterans Administration pays billions of dollars annually for disability, including for veterans with PTSD. Accordin…

MindMed announces Phase 1 study of MDMA-like substances

On the heels of launching a Phase 2b study of LSD in generalized anxiety disorder, MindMed (Nasdaq: MNMD) has dosed the first subject in a Phase 1 study evaluating MDMA-like substances in healthy volunteers.

MindMed is developing a synthetic enantiomer of MDMA as a potential treatment for core symptoms of autism spectrum disorder (ASD). Early evidence suggests that its MM-402 MDMA-based drug candidate can reduce social impairment.

Like LSD, MDMA (methylenedioxy-methamphetamine) is a Schedule I drug. While the U.S. government outlawed LSD in 1968, MDMA was banned in 1985.

The FDA, however, is purportedly considering approving MDMA as a treatment for post-traumatic stress disorder in the coming years.

Matthias Liechti, principal investigator of the Phase 1 study on MDMA-like substances on behalf of MindMed, noted that the amphetamines MDMA and methylenedioxyamphetamine (MDA) can have mixed subjective effects — especially at the onset of response…

FDA could approve MDMA and psilocybin in 2 years

To deal with a worsening mental health crisis in the U.S., the FDA is reportedly considering approving 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin within the next two years, according to a letter from a Substance Abuse and Mental Health Services Administration (SAMHSA) published by The Intercept.

MDMA could be authorized as a treatment for post-traumatic stress disorder, while psilocybin could be authorized for treating depression.

Both drugs have received Breakthrough Therapy Designation from the FDA.

Clinical trial data suggest that MDMA and psilocybin, when paired with psychotherapy, can offer substantial therapeutic value to many patients.

“SAMHSA agrees that too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis,” wrote Assistant Secretary for Menta…

MDMA elects Outset CEO Leslie Trigg as chair

Outset Medical Chair and CEO Leslie Trigg [Photo courtesy of Outset Medical]The Medical Device Manufacturers Association (MDMA) has elected Outset Medical Chair and CEO Leslie Trigg as chair of the trade group’s board of directors.

MDMA announced the leadership change today, following the Washington, D.C.-based industry association’s annual meeting last week.

“Medical technology innovators are at the forefront of improving patient outcomes and reducing the cost of care, and I am honored to lead MDMA as they continue their tremendous work as the leading voice of our industry,” Trigg said in a news release. “Modern technology is impacting when, where and how healthcare can be delivered. Together, we have the privilege of imagining what the future of healthcare could look like, and turning invention into reality.”

Get the full story at our sister site, Medical Design & Outsourcing.

MDMA elects Outset CEO Leslie Trigg as chair

Outset Medical Chair and CEO Leslie Trigg [Photo courtesy of Outset Medical]

The Medical Device Manufacturers Association (MDMA) has elected Outset Medical Chair and CEO Leslie Trigg as chair of the trade group’s board of directors.

MDMA announced the leadership change today, following the Washington, D.C.–based industry association’s annual meeting last week.

“Medical technology innovators are at the forefront of improving patient outcomes and reducing the cost of care, and I am honored to lead MDMA as they continue their tremendous work as the leading voice of our industry,” Trigg said in a news release. “Modern technology is impacting when, where and how healthcare can be delivered. Together, we have the privilege of imagining what the future of healthcare could look like, and turning invention into reality.”

Trigg succeeds Avalign Technologies CEO Jeff McCaulley, who held the role …

Medtech gets behind breakthrough device law for seniors

Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation.

Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that the Centers for Medicare and Medicaid Services (CMS) has delayed implementing with a final rule.

Get the full story on our sister site, Medical Design & Outsourcing.

As interest in psychedelic medicine grows, Big Pharma sits on the sidelines

Image by Ben Johnson from Pixabay

While Big Pharma has yet to embrace psychedelics as potential treatments for depression and other psychiatric disorders, interest in psychedelic medicine is building.

Earlier this month, Nature Medicine published a Phase 3 study indicating that psychotherapy assisted with methylenedioxymethamphetamine (MDMA) was a more effective treatment for post-traumatic stress disorder (PTSD) than therapy alone. The study authors concluded that MDMA yielded a larger effect size than antidepressants Zoloft (sertraline) and Paxil (paroxetine).

The FDA granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD in 2017. Approval could come in 2023, according to The New York Times.

[Related: Debate series considers the therapeutic promise and pitfalls of psychedelics]

Last month, NEJM summarized the results of a Phase 2 study that found that psil…

Fifth round of medtech user fee talks set to begin soon

Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances.

The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de novo requests.

Negotiations on MDUFA V were scheduled for April 2020 but were waylayed by the pandemic. Following an initial stakeholder meeting in October, the FDA now says the virtual monthly meetings may begin in March. Congress must pass by MDUFA V by September 2022, when the current user fee law expires.

Get the full story on our sister site, Medical Design & Outsourcing.