Agreement underscores benefit of collaboration to accelerate review of new evidence-based treatment options for people with PTSD
Submission of new drug application expected in the second half of 2023
SAN JOSE, Calif., June 21, 2023 /PRNewswire/ — MAPS Public Benefit Corporation (“MAPS PBC”), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced that the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, has agreed to provide data to supplement the company’s new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for MDMA-assisted therapy as a treatment for post-traumatic stress disorder (“PTSD”).
“We are incredibly grateful to NIDA for this data sharing agreement and believe it is a good example of how public and private data sharing can help future development of new effective treatment options for people in need,” said Amy Emerson, chief executive officer, MAPS PBC. “The NIDA data is an important addition to support the evaluation of MDMA’s safety and will be a critical component of the NDA we plan to submit later this year. With four decades of independent research looking at its safety, MDMA is one of the most well-studied molecules in clinical development today.”
Under the agreement, NIDA will share select pharmacokinetic (PK) data from a previously published1,2 ,3 ,4 ,5 early-stage MDMA study conducted in the Intramural Research Program of NIDA, for the Safety Pharmacology section of MAPS PBC’s NDA. The FDA requested data on the PK of acute MDMA administration to help investigate the safety profile of MDMA and NIDA has agreed to share these data with MAPS PBC obviating the need for new safety studies to secure that PK data.
“Extensive research was conducted on MDMA pharmacokinetics over the last 19 years, and I am pleased to see this robust repository of data used to further advance knowledge about a potential new therapeutic option for people with PTSD,” said Marilyn Huestis, Ph.D., an independent scientific advisor to MAPS PBC and former Chief, Chemistry and Drug Metabolism at NIDA. “Research is meant to be a collaborative process where findings are shared and built upon to contribute to the common good; in this case in support of people with PTSD who historically were underserved.”
In 2017 the FDA granted MDMA-assisted therapy Breakthrough Therapy designation, a process designed to expedite the development and review of drugs intended to treat certain conditions and that demonstrate substantial improvement over existing therapies. MAPS PBC expects to submit the new drug application to the FDA in the second half of 2023.
To date, MDMA-assisted therapy has not been approved by the FDA. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
PTSD is a mental health condition affecting approximately 13 million Americans each year6, yet currently available treatments only provide modest efficacy.7 People with PTSD can experience debilitating symptoms that impact nearly all areas of a person’s life.8 They also frequently experience comorbidities including anxiety, depression, and substance use disorder.9 PTSD has an enormous economic impact resulting in an annual cost of over $232 billion.10 Currently available treatments for PTSD do not necessarily address the full spectrum of patients who need treatment and may not provide adequate relief from debilitating symptoms.7 These limitations combined with high treatment discontinuation rates11 underscore the urgent need for novel and effective therapies.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) is focused on developing and commercializing prescription psychedelics to bring better treatments to those living with mental health conditions. Founded in 2014, MAPS PBC is a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) non-profit organization.
1 Kolbrich, E.A., et al., Plasma pharmacokinetics of 3,4-methylenedioxymethamphetamine after controlled oral administration to young adults. Ther Drug Monit, 2008. 30(3): p. 320-32.
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SOURCE MAPS Public Benefit Corporation