Potential approval for MDMA to treat PTSD could lead to significant expansion

  • Backer of MDMA therapy sees ‘exponential’ growth following FDA approval
  • MDMA granted ‘breakthrough therapy’ status with the FDA
  • New-drug application submitted for MDMA to treat PTSD
  • Potential final approval in about eight months
  • MDMA to be administered in therapeutic settings only
  • Hope for growth similar to Johnson & Johnson’s Spravato ketamine treatment
  • Possibility of treating up to 100,000 patients with MDMA in 2024
  • Health-insurance coverage and support from Veterans Affairs
  • MDMA therapy may lead to further acceptance of psychedelic drugs
  • Investment needed in clinical infrastructure and therapy facilities

A financial backer of MDMA therapy believes that FDA approval for the drug to treat PTSD could result in ‘exponential’ growth. MDMA, also known as molly or ecstasy, has already been granted ‘breakthrough therapy’ status by the FDA. The nonprofit organization MAPS Public Benefit Corp. has submitted a new-drug application for MDMA to be used with psychological intervention in PTSD treatment. If approved, the drug would only be administered in therapeutic settings. Cody Shandraw, a managing partner of Ambria Capital, has donated to MAPS Public Benefit Corp. and predicts FDA approval as early as August. He hopes that the growth of MDMA therapy will follow a similar trajectory to Johnson & Johnson’s Spravato ketamine treatment. Shandraw envisions up to 100,000 patients being treated with MDMA in 2024 and as many as 750,000 in 2025. Health-insurance coverage and support from the U.S. Department of Veterans Affairs are expected. The approval of MDMA therapy could also pave the way for acceptance of other psychedelic drugs. However, further investment in clinical infrastructure and therapy facilities is needed to support the expansion of MDMA therapy.

Public Companies: MAPS Public Benefit Corp. (null), Johnson & Johnson (JNJ), Compass Pathways (CMPS), MindMed (MNMD)
Private Companies: Ambria Capital
Key People: Cody Shandraw (Managing Partner of Ambria Capital, President of Healing Realty Trust)

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Factuality Level: 7
Justification: The article provides information about the potential approval of MDMA for therapeutic use by the FDA and the financial backer’s perspective on its growth. It also mentions the current status of MDMA as a breakthrough therapy and the submission of a new-drug application. The article includes data on the number of clinics administering ketamine treatment and speculates on the potential number of patients that could be treated with MDMA. It also discusses the plans for therapy facilities and the potential coverage by health insurance providers and the Department of Veterans Affairs. The article mentions the prevalence of PTSD and the unconsolidated nature of the behavioral mental health sector. It also discusses the potential impact of MDMA’s approval on other psychedelic drugs and the investment in the psychedelic-drug industry. Overall, the article provides factual information and includes some speculative statements based on the financial backer’s perspective.

Noise Level: 6
Justification: The article provides information on the potential growth of MDMA for therapeutic use and the efforts to legalize it. It mentions the financial backer and their belief in the FDA approval. It also discusses the need for therapy centers and trained therapists to support the rollout of MDMA. The article includes data on the number of clinics administering ketamine treatment and speculates on the potential number of patients treated with MDMA in the future. It mentions the possibility of health insurance coverage and the impact on PTSD patients. The article also touches on the broader psychedelic drug industry and the need for investment in clinical infrastructure. Overall, the article provides relevant information and insights into the potential future of MDMA therapy, but it lacks in-depth analysis and scientific rigor.

Financial Relevance: Yes
Financial Markets Impacted: The potential approval of MDMA for therapeutic use by the FDA could impact the pharmaceutical industry, particularly companies involved in the development and production of psychiatric medications. It could also create opportunities for therapy centers and real estate companies specializing in providing facilities for MDMA treatment.

Presence of Extreme Event: No
Nature of Extreme Event: No
Impact Rating of the Extreme Event: No
Justification: The article discusses the potential approval of MDMA for therapeutic use by the FDA, which could have financial implications for the pharmaceutical industry and related sectors. However, there is no mention of any extreme events or their impact.

Reported publicly: www.marketwatch.com