Medicinal

Psychedelic therapy for Canada’s SAP to be provided by Mydecine

Psilocybin and MDMA therapy will be provided to patients under the programme.

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Mydecine has signed a Letter of Intent (LOI) with The Newly Institute to provide psychedelic-assisted psychotherapy to patients for Health Canada’s Special Access Program.

The companies will be partnering to co-develop protocols, therapy manuals and training for psychedelic-therapy to treat patients who need specific care.

Canada recently made amendments to the Controlled Drugs and Substances Act and the Food and Drugs Act which will now allow authorised patients access to psychedelic medicines under its Special Access Program (SAP).

Mydecine CMO Dr Rakesh Jetly commented: “The recent changes to Canada’s SAP program are encouraging, but in order to make a significant positive impact on patients, we need to ensure these therapies are carried out safely and effectively. 

“We are excited to work hand-in-hand with The Newly team to develop the evidence-based protocols, therapy manuals, training and other resources physicians need in order to promote the successful integration of these treatments into their existing infrastructure.”

The Newly Institute offers rapid access outpatient programs providing innovative mental health, addiction and trauma therapies. Together, the companies will create the package of resources needed for patients and practitioners to successfully gain acceptance onto the programme, including therapy manuals for a variety of indications. 

Mydecine will provide cGMP psilocybin and MDMA alongside safety and efficacy data, and The Newly will provide the clinic locations and experienced therapists needed to perform the treatments. 

President and CEO of The Newly Arthur Kwan commented: “Our goal at The Newly is to build a network of clinics across Canada that deliver innovative and leading-edge mental health treatments to individuals in need. 

“The platform we’re developing can be very effective in enabling us to deploy new and innovative best-practice treatments and therapies. We are pleased to partner with a company like Mydecine to enhance the mental health care being provided to Canadians.”

Newly’s CSO Dr Marshall Ross added: “We believe this partnership with Mydecine brings many positives to The Newly, and more importantly, to Canadians in need. 

“Research supports that psychedelic-assisted psychotherapy can break down deeply rooted psychological defenses, facilitate therapeutic breakthroughs and effect substantial improvements in long-term mental health. 

“We will promote and exemplify safe and effective treatment techniques by implementing and studying our evidence-based protocols for the use of psychedelics in our practice.”

Mydecine will also support The Newly’s patients with post-therapy needs through their digital health platform called Mindleap, and both parties plan to create an exclusive research database to aid in future developments.

Mydecine CEO Josh Bartch added: ”We couldn’t think of a better partner than The Newly to act as the model site for our SASSP. 

“Both companies come with incredibly talented and experienced medical and scientific teams who value treatments based on evidence and data. Collaboration is the foundation of all work processes and essential to our overall success. 

“I believe this partnership will set the gold standard for these psychedelic-assisted therapies while making them more accessible to patients.”

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