Issue 167

MDMA for PTSD receives priority review for New Drug Application

Lykos Therapeutics, formerly MAPS Public Benefit Corporation, has announced it has received FDA acceptance and priority review for a New Drug Application (NDA) concerning its MDMA-assisted therapy for PTSD.

The FDA has accepted Lykos’s NDA for MDMA capsules used in combination with psychological intervention. This intervention includes psychotherapy and other supportive services provided by a qualified healthcare provider for individuals with PTSD.

Lykos has stated that the FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. Current statistics show that 89% of applications that meet their PDUFA deadline are approved.

If this application is approved, it would make this the first MDMA-assisted therapy and psychedelic-assisted therapy.

PSYCHEDELIC EXPERIENCES LINKED WITH IMPROVED SEXUAL FUNCTION

A new study published in Nature Scientific Reports and carried out by researchers from the Centre for Psychedelic Research at Imperial College London has found that psychedelics may improve sexual function.

Study participants reported improvements for up to six months after their psychedelic experience, including improvements in their enjoyment of sex, sexual arousal, satisfaction with sex, attraction to partner, their own physical appearance, communication, and their sense of connection.

INVESTORS PILE INTO PSYCHEDELIC DRUG START-UPS TACKLING MENTAL HEALTH

Sovereign wealth funds Temasek and Mubadala are in talks to fund biotech groups harnessing psychedelics.

The Financial Times reports that biotechnology start-ups seeking to use psychedelic drugs to treat mental health disorders are raising hundreds of millions of dollars, as investors are tempted back to the sector by watershed clinical data and regulatory approvals expected this year.

Groups seeking to harness psychedelics raised at least $163mn across five deals in January.

BUSINESS AND INVESTMENT

Wall Street is embracing the psychedelic industry—and it’s causing a culture clash, reports Fast Company.

PharmAla has entered into a relationship with Red Light Holland to consult on the development of Psilocybin Products extracted from Red Light’s mushroom portfolio.

Cybin has confirmed that the Japan Patent Office has granted two additional patents in support of its DMT programme.

Choose Your Horizon has raised $580,000 in its first equity fundraising campaign in twelve weeks. With the equity, the company plans to expand into all 50 states by the end of 2024.

SCIENCE AND RESEARCH

For a new UC Berkeley professor, psychedelics and octopuses may hold keys to the human mind.

NPR explores psychedelic therapy for military members in light of legislation that includes funding for clinical trials of psychedelics for service members.

Find out why parents are ‘microdosing’ magic mushrooms and how the fungi helps with the stresses of life.

Carlton University explores how psychedelic derivatives could help in the mission of finding innovative new medicines that may help treat depression.

REGULATION AND LEGISLATION

Professor David Nutt tells The Standard that “denying access to psychedelics is like denying access to the Covid vaccine.”

Arizona’s Health and Human Services Committee has approved a bill to legalise psychedelic mushrooms for mental health treatment.

ARTICLES OF INTEREST

More than 40% of parents in Scotland said they were worried about the impact of mental health on their family, a survey by the NSPCC has revealed.

The EU executive is drafting a strategy designating biotech critical to the continent’s strategic autonomy, according to a leaked document seen by Euronews.