MDMA is an effective treatment for severe PTSD in first Phase 3 psychedelics trial by MAPS

MAPS revealed some “highly statistically significant results” from its Phase 3 trial for MDMA-assisted therapy for PTSD, which will be published in full in Nature Medicine

Highlights from first Phase 3 trial of any psychedelic-assisted therapy:

  • An incredible 67% of participants with PTSD who received three MDMA-assisted therapy sessions no longer had a PTSD diagnosis post-treatment.
  • 88% had a “clinically meaningful reduction in symptoms”
  • 90 patients were treated (all had chronic, severe PTSD for an average of 14 years stemming from events like combat, accidents, abuse)

Road Ahead: MAPS says the results could pave the way for FDA approval in 2023.

“MDMA is an experiential therapeutic and therefore necessitates the appropriate set and setting to truly guide change and recovery,”  said lead author Jennifer Mitchell, Ph.D.

 “While many forms of PTSD therapy involve recalling previous trauma, the unique ability of MDMA to raise compassion and understanding while tamping down fear is likely what enables it to be so effective.”

MindMed’s Project Angie study investigates LSD for pain

Based on preliminary evidence suggesting that psychedelics could be a novel treatment for pain, MindMed (NEO:MMED) is moving ahead with Project Angie, which will explore LSD’s potential to treat pain. The company will submit an application for a Phase 2a Proof of Concept study later in 2021.

Follow the money

The company is targeting the forecasted $31 billion analgesics market expected by 2030 and the lack of alternatives to opioids.

“Evidence dating back to the 1950s suggests that LSD and other psychedelics may have analgesic effects, but this treatment area remains largely untapped by companies studying psychedelics, with the majority of research focusing solely on psychiatric indications” said MindMed chief development officer Rob Barrow. 

Field Trip, Novamind expand psychedelic treatment clinic footprint

Two leading psychedelic therapy companies are expanding their clinic numbers.

  • Field Trip (CSE: FTRP) opened its fifth ketamine therapy clinic location, this time in Houston, and has started work on clinics in San Diego and San Carlos (CA); Seattle, Washington, DC, and Fredericton, New Brunswick.

“Every week, new evidence about the safety and efficacy of psychedelic therapies is being published,” said SVP and medical director Dr. Ben Medrano. “The academic data matches closely with what we are seeing in our Field Trip Health centers — that psychedelic-assisted therapy is a safe and effective treatment for depression, anxiety and other mental health challenges.”

  • And citing a two-week waiting list for new clients, Novamind (CSE:NM) is doubling its number of Cedar Psychiatry clinics in Utah from four to eight. The number of patients who can access its ketamine and psilocybin therapy will increase from 20,000 to 65,000, according to the company. 

“Expect continued and aggressive growth as we expand Novamind’s clinic network and clinical research infrastructure ahead of the FDA’s anticipated approvals of MDMA and psilocybin,” said CEO and director Yaron Conforti.

Some Indigenous communities aren’t on board with psychedelics decriminalization

Western science and corporate interests are powerful forces rapidly changing legislation and attitudes towards psychedelics, but they’re largely ignorant to Indigenous perspectives, writes Mic

While advocates frequently point to centuries-long use of substances in some Indigenous rituals and medicine and claim decriminalization would benefit these communities, they ignore that:

  • In 2020, the National Council of Native American Churches and the IPCI asked that peyote not be included in decriminalization legislation.
  • Peyote is already decriminalized for religious freedoms reasons for Indigenous communities, and some are concerned about plant conservation and/or sacred traditions.

“The original decriminalization movement started too quickly without securely thinking about the network of interconnected relationships with plants and Indigenous communities,” said Sandor Iron Rope, president of the Native American Church of South Dakota.

Bexson Biomedical patents subcutaneous ketamine delivery for pain management

Santa Barbara, California-based Bexson Biomedical was granted a patent for several delivery methods of psychedelics for mental health and pain, including its BB106 ketamine therapy, which is a subcutaneous delivery.

“This technology provides a great new benefit for patients,” said co-founder Dr. Jeffrey Becker. “We believe that the subcutaneous route of administration is perhaps the best method to deliver a controlled substance in a controlled manner.”

Bexson is also planning clinical trials evaluating the effectiveness of the delivery methods, and they are also developing a “wearable patch pump” in a partnership with Stevanato Group.

Report Readout

Why psychedelics are making a comeback, according to Bloomberg.

Ketamine is a worthy treatment but challenging to prescribe to patients.  

Former Navy SEAL Marcus Capone is advocating that California legalize psychedelic therapy to treat veterans with PTSD. 

After the lifting of a cease trade order, Champignon Brands has a new name: Braxia Scientific

The New York Times is taking an in-depth look at the research into MDMA. 

Amanda Fielding has finally been proven right.