Psyched: 12 States Discuss Legalization Bills, Ceremonies For Veterans With TBI, Ketamine And MDMA Fast-Tracks & More

Psychedelics Legislation: The Latest On Hawaii, Virginia, Missouri & More

• Hawaii: A bill to establish the Therapeutic Psilocybin Working Group, to study psychedelics' medicinal and therapeutic effects, has been approved with recommended amendments. The measure won support from Democratic Governor Josh Green’s office.

• Virginia: The state’s full Senate approved a bill with 25 votes in favor and 15 against. The new measure would establish a statewide psilocybin advisory board and reschedule the psychedelic under state law.

• Missouri: A bill legalizing psilocybin-assisted therapy for qualifying patients with a physician’s recommendation and expanding treatment access to adults over 21 once psilocybin is federally rescheduled has been taken off the House calendar after a second time read on Jan. 19, no hearings scheduled.

• New York: The Empire State is seeing a fourth proposal for the 2023 session calling for the legalization of medical psilocybin with a certified facilitator at a controlled setting. It would also establish a grant program for veterans, first responders, retired first responders and low-income individuals to receive treatment with psilocybin or MDMA. It has been at the Senate’s Finance committee since Jan. 31.

Learn more on West Virginia, New Hampshire, Illinois, Massachusetts, Washington, Connecticut, Arizona and California active psychedelics bills HERE.

See also: Can Ketamine Treat Alcohol Addiction? The Awakn Approach

New Research Program: Effects Of Psychedelic Group Ceremonies On Veterans With Traumatic Brain Injury

The non-profit Heroic Hearts Project (HHP), psychedelic retreats and healthcare company Beckley Retreats and Imperial College London (ICL)’s Centre for Psychedelic Research have partnered to advance new research on the psychological effects of psilocybin ceremonies on veterans suffering from traumatic brain injuries (TBI).

The observational study, sponsored by ICL and led by its director Dr. Robin Carhart-Harris, is set to begin in March at Beckley Retreats’ location in Jamaica.

Dr. Carhart-Harris says the hope is to collect “some much-needed data on the potential of real-world psilocybin mushroom use for the treatment of brain injury-related symptoms in combat veterans,” adding that psychedelics’ mainstream makes it increasingly important to monitor their use and utility outside of clinical and lab settings.

“This program and research is vitally important for our soldiers coming home with all numbers of traumas, and head trauma is one that is rarely given the attention it deserves,” said Beckley Retreats CEO Neil Markey.

Learn more about the study HERE.

Ketamine Treatment For Alcohol Use Disorder, MDMA Drug Candidate And Transdermal Patch

Awakn Life Sciences Corp. AWKNF, a biotech company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), has been granted an Innovation Passport for its proprietary Ketamine-Assisted Therapy (KAT) to treat severe AUD.

The passport was granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and is aimed at accelerating time-to-market and facilitate patient access. 

More on the treatment’s fast-track HERE.

Meanwhile, Health Canada-licensed psychedelics producer Optimi Health Corp. OPTHF has completed the first batch of its proprietary pre-clinical MDMA drug candidate to be used in drug development, clinical trials and individual patients authorized by the Special Access Program (SAP) or Australia’s Authorized Prescriber (AP) scheme as of July 1.

“Optimi felt it was crucial to fill the void that exists in accessibility to high-quality MDMA drug candidates,” said CEO Bill Ciprick referring to patients and providers anticipating access to psychedelic-assisted therapy. “An inherent level of trust in the safety and purity of the product being administered is essential.”

Also, life sciences psychedelics company Revive Therapeutics RVVTF has entered into a supply deal with MDXX-class molecules producer PharmAla Biotech Holdings for the latter’s GMP-compliant MDMA LaNeo towards the development of Revive’s microneedle patch delivery system. 

“Securing the supply of MDMA from PharmAla allows us to confidently advance our upcoming product and clinical development plans with our MDMA microneedle patch for mental health and abuse disorders,” said Revive CEO Michael Frank.

More on Optimi’s MDMA drug and Revive’s MDMA delivery technology HERE.

The Milestone Round

Each week, we learn about new clinical trials, the creation of psychedelic-based compounds and novel potential treatments for those suffering from mental and physical health conditions:

• Australia’s recent approval of psilocybin and MDMA-assisted therapies for the treatment of certain cases of mental health conditions has gained wide acclaim within the psychedelics world, including bullish comments by MAPS’ Rick Doblin and Numinus NUMIF’s Payton Nyquvest and expectancy on how other countries might move next. 
• PharmaTher PHRRF has recently submitted a meeting package to the FDA to advance proprietary ketamine KETARX’s on-body pump system and submit a New Drug Application (NDA), while Awakn has initiated a feasibility study of formulating and delivering MDMA through partner Catalent’s proprietary oral, fast-dissolving tablet Zydis technology.
• Private Canadian company Cube Psytech Holdings is set to acquire Translational Life Sciences (TLS) and nab a drug discovery pipeline with more than 1,000 extracted botanical compounds and profiling data on over 200 mushroom species, an interesting move considering the psychedelic API market is set to reach $6.1 billion by 2033.
• Seelos SEEL’ ethno-bridging study on Japanese and non-Asian participants assessing the effects of its novel intranasal racemic ketamine, the testing of a psilocybin-assisted therapy protocol for the treatment of Alcohol Use Disorder in Alberta, Canada. A trial will assess the combination of MDMA and psilocybin in an experiential study with therapists.
• Two universities have seen movement within their medical schools: California’s UC-Davis has launched the new Institute for Psychedelics and Neurotherapeutics, and Texas’ Baylor College of Medicine now has its Center for Medical Ethics and Health Policy around psychedelics’ legal and ethical implications in society.
• Check out our interview series with exclusive first-hand insights from Fox Rothschild’s specialized cannabis lawyer Joshua Horn: Psychedelics Education, Rescheduling & Decriminalization and Social Equity, Adult-Use & Commercialization, Lessons From Cannabis.

See also: Last Week's Edition Of 'Psyched'

Psychedelics EFTs Weekly Performance

This is how the sector’s major EFTs performed in the week spanning February 6-10.

• AdvisorShares Psychedelics PSIL opened Monday 6 at $2.30, consistently better than prior weeks' openings at $2.16, $2.23 and $2.29. After a slight increase on Tuesday, Friday’s close was set at $2.19, lower than prior week’s at $2.28 and closer to two weeks’ past closing at $2.18.
  For this EFT, the yearly price range was once between $6.26 and $1.82 and, after gradual changes in the last months, is now set between $5.00 and $1.79.

• The Elemental Advisors PSYK EFT PSYK opened Monday 6 at $18.40, a rise considering the previous opening at $17.99 and again closer to Monday, Jan. 23’s great performance at $18.48. After peaking to $18.62 on Tuesday 7 -over former week’s highest at $18.52,- price fell all the way to closing at $17.97 on Friday 10, considerably lower than Friday 3’s closing at $18.30.
  For this EFT, the yearly price range was set between $23.32 and $16.70, and now the lowest price has been adjusted to $16.28.

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