Psyched: Canada's Case For Psilocybin Access And Microdose Trial, US Reform Update, Battle With DEA & More

Canadian Patients Demand Access To Psilocybin: Federal Lawsuit, Official Petition & Failing Mechanism

A patient-led lawsuit against the Canadian government is claiming access to therapeutic psilocybin is a constitutional right under the Canadian Charter of Rights and Freedoms.

In 2020, Health Canada started granting Section 56 exemptions for psilocybin-assisted therapy under the federal CDSA, later adding a legal pathway through an amendment to the Special Access Program for patients with a “serious or life-threatening condition.”

Yet this protocol has proven insufficient for those in need: the plaintiffs applied for access to psilocybin, in some cases not obtaining the renewal for their already-approved treatment.

Keep reading HERE.

Canadian At-Home Microdose Psilocybin Clinical Trial Finalized

Biopharma company Apex Labs Ltd. has completed one of the first take-home microdose psilocybin clinical trials, meeting all study endpoints over a two-month period with no adverse events reported.

CEO Tyler Powell called it a clinical milestone and said he's certain it will help the company's position as a first mover in take-home psilocybin treatment while advancing its commitment to treating “the substantial unmet need” within the Veteran community. 

The trial also assesses the stability of symptoms when transitioning from illicit unregulated psilocybin to regulated APEX-52.

Keep reading HERE.

Psychedelics Reform Update: Rhode Island's Bipartisan Bill, Montana Proposal Gutted And More

While federal regulations advance at a comparatively mild pace, states across the US are running local reforms, with some moving forward quickly. Latest advancements as of March 31:

• Rhode Island: Bipartisan S0806 amending state laws to legalize possession of up to 1 ounce of psilocybin, home cultivation and establishing rules for distribution and medical prescription was introduced on March 23 and referred to the Senate Judiciary. 

• Connecticut: HB 6734 decriminalizing possession of up to 0.5 ounces of psilocybin mushrooms was green-lighted at the House’s Judiciary joint committee on March 30 and was filed with the Legislative Commissioner's Office.

Read more on Washington, Massachusetts, Hawaii, Nevada, Missouri and Montana’s proposals HERE.

Meanwhile, news coming from the two places where psychedelics regulations are most advanced include the approval of grower’s licenses and progress on the nominations for the state’s psilocybin advisory council. 

Bipartisan Right To Try Act Would Compel DEA To Allow Psychedelics And Cannabis For Certain Patients

Congressional Reps. Earl Blumenauer (D-OR) and Nancy Mace (R-SC) filed a bill to allow terminally-ill patients to access Schedule I drugs that have been tested in clinical trials, such as cannabis and certain psychedelics under the federal Right to Try (RTT) laws.

The new HR1825 aims to “expand access to life-changing treatments by including in the federal Right to Try Act Schedule I substances that have completed Phase 1 clinical studies,” stated Blumenauer, referring to psilocybin and MDMA as the two which have shown “tremendous care potential” in both Phase 1 and 2 clinical trials.

Keep reading HERE.

The Milestone Round

Each week, Benzinga learns about new clinical trials, compounds and potential treatments:

• PharmaTher Holdings PHRRF is preparing for a Phase 3 trial on its novel ketamine treatment for levodopa-induced dyskinesia in Parkinson’s.

• Silo Pharma SILO is set to patent a novel ketamine treatment for chronic pain management including fibromyalgia.  

• Revive Therapeutics RVVTF has begun enrolling patients for its Phase 1/2 clinical trial on psilocybin for meth use disorder.

• Private company Psilera continues advancing its next-gen, non-hallucinogenic psychedelics toward clinical trials.

• IntelGenx IGXT reported its fourth-quarter and full-year financial results.

• Numinus Wellness NUMIF launched a series of psychedelic-assisted therapist training courses for practitioners.

• Miscellaneous this week includes Diplo’s marathon run on LSD, Reggie Watts’ self-discovery relationship with cannabis and psychedelics, and a small recap on celebrities actively embracing psychedelic therapy including Berner’s call on proper dosing. 

Here’s a bit of what you can expect from our extraordinary Psychedelics Capital Conference taking place in Miami in just a few days!

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

Benzinga’s Psychedelics Capital Conference

Benzinga’s Psychedelics Capital Conference is almost here! 

April 13th at the Fontainebleau Miami Beach Hotel will be THE place to set up deals, raise money, meet investors and key partners and learn from the industry’s greatest.

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