psychedelic therapy Archives - Medical Design Sourcing

FDA fast-tracks psilocybin-based CYB003 for depression

The FDA continues to signal openness to psychedelic-based therapies. Following its recent Breakthrough Therapy Designation (BTD) for a potential LSD-based anxiety treatment, the agency has extended the same status to Cybin Inc.‘s CYB003 for major depressive disorder (MDD). The move marks the first FDA Breakthrough Therapy Designation for an adjunctive, psychedelic-based Major Depressive Disorder treatment. This move expedites CYB003’s review process and provides increased FDA guidance throughout development.

“I think there’s a positive attitude at the FDA,” said Doug Drysdale, CEO of Cybin. He noted that a significant number of agency representatives attended their end of Phase 2b meeting, indicating strong interest across departments. “They seem excited about the potential of these new treatments.”

FDA’s Breakthrough Designations for psychedelic and MDMA therapies

The FDA has previously granted Breakthrough Therapy Designation (BTD) to psiloc…

Compass Pathways names board member at pivotal moment for psychedelic industry

Compass Pathways has named biotech exec Daphne Karydas to its board. Karydas is the president and chief financial officer of Flare Therapeutics Inc., which is developing drug discovery programs targeting transcription factors for cancer and other diseases. Signs point to a potential FDA approval of psilocybin and MDMA under strict controls in the coming years, but the psychedelic therapy market has seen significant volatility in recent years. Since the company went public in September 2020, Compass has seen its valuation drop by more than two-thirds. Its stock, however, has shown some recent resilience rebounding by 17.49% year-to-date.

The volatility isn’t unique to Compass. Fellow psychedelic stock company ATAI Life Sciences NV (NASDAQ:ATAI) has seen its valuation plummet by 93% since its debut in mid-2021. The market fluctuations mirror the challenges of navigating the psychedelic therapy space, increasing the need for seasoned leadership.

In addi…

Psychedelic therapy at a crossroads at the dawn of 2023

[Image courtesy of Erin Williamson under the Creative Commons License via Flickr]

In several ways, psychedelic therapy continued to make strides toward legitimization in 2022. Michael Pollan’s best-selling psychedelic treatise “How to Change Your Mind” formed the basis for a popular Netflix series. Several celebrities declared that psychedelics had improved their lives.

Decriminalization efforts gaining steam

Colorado decriminalized psychedelic plants, as did the city of San Francisco. (Several other U.S. cities have done so earlier.) On January 1, 2023, Oregon will authorize therapy based on the magic mushroom compound psilocybin under Ballot Measure 109, which passed in November 2020. The state will restrict the treatment to licensed facilities with therapists with specific training. In 2023, New York state and California could legalize natural psychedelics. In Canada, Quebec became the…

What is the role of preparation and integration in psychedelic therapy?

[Photo by Polina Kovaleva]

The organizations that have made the most progress in the clinical development of psychedelic agents — broadly defined — have tended to prioritize psychological support before and after drug administration.

A position statement from the the American Psychiatric Association notes that, in preliminary research, psychedelics “have generally been combined with structured psychotherapy protocols proposed by investigators as integral to achieving full therapeutic benefit and ensuring participant safety and wellbeing.”

According to Doug Drysdale, CEO of Cybin (NYSEAMERICAN:CYBN), such support shouldn’t be confused with psychotherapy. “But getting the patient prepared is important,” Drysdale added. Such sessions can help set patients’ expectations, so they are not shocked or surprised during the psychedelic therapy session. Such sessions can also help…