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Sunshine, Sassafras, and MDMA

Sassafras: the Root of MDMA

Sassafras, a plant native to Eastern North America and Asia, has long been known for its medicinal properties. Among the Kituwah (Aniyvwiya) people of the Southeastern US, it serves as a traditional remedy to treat skin conditions, fevers, and urinary issues. In Traditional Chinese Medicine, Asian varieties of Sassafras are utilized to address ailments such as rheumatism and trauma. Today, the Sassafras tree faces endangerment due to deforestation and overuse.

Modern research sheds light on the therapeutic attributes of Sassafras. Its oil, roots, and bark are analgesic and have antiseptic properties. Interestingly, Sassafras was once utilized in creating the root beer flavour until concerns around its carcinogenic properties were confirmed.

At the chemical core of Sassafras lies Safrole, a compound used as a precursor in the synthesis of 3,4-Methylenedioxymethamphetamine (MDMA). MDMA, known colloquially as Ecstasy or Molly, is a potent empathogen-entactogen with stimulant properties. Its effects encompass altered sensations, increased energy, empathy, and pleasure.

Sunshine Labs, Health Canada and FDA Approval

Sunshine Labs holds one of the few legal licenses to produce, sell and transport MDMA through Health Canada. We have established global partnerships and supply agreements with others in this space. Sale is allowed to licensed dealers, pharmacists, practitioners, hospital employees or the Ministry.

In 2017, a significant milestone was achieved in mental health treatment when the FDA approved research into MDMA-assisted psychotherapy. This approval paved the way for exploring MDMA’s benefits in treating conditions such as PTSD, Major Depressive Disorder, social anxiety in autistic individuals, alcohol use disorder, and terminal illnesses.

The Multidisciplinary Association for Psychedelic Studies (MAPS) then embarked on an ambitious endeavour. They announced 18 different phase 2 and phase 3 studies, setting the stage for a New Drug Application (NDA) submission to the FDA. With hopes of securing FDA approval by the end of 2024, MAPS is enroute to establish MDMA-assisted therapy in mainstream mental health care.

MDMA-assisted therapy follows a structured approach. Patients undergo 2-3 therapy sessions within a 12-week period, ingesting 120 mg of MDMA. An optional half-dose of 40 mg is administered approximately two hours later, aiming to extend the therapeutic effects lasting up to eight hours.

Post Traumatic Stress Disorder

Pioneering clinical trials conducted by MAPS have showcased MDMA’s potential in managing PTSD symptoms. In one pivotal trial involving 104 participants with long-term moderate to severe PTSD, MDMA-assisted therapy led to significantly greater symptom reduction compared to the placebo group. Post-treatment assessments revealed that a majority of participants in the MDMA group no longer met PTSD criteria.

These promising findings led MAPS to seek authorization from the FDA for the employment of MDMA as a standard treatment for PTSD. If successful, MDMA could revolutionize mental health care, offering a novel therapeutic approach for those in need.

The convergence of MAPS’ research efforts and FDA approval processes represents a significant step forward for allowing people to access the healing potential of MDMA. As psychedelic-assisted therapy continues to evolve, MDMA stands poised to transform the landscape of mental health treatment, offering renewed hope and healing to people worldwide. 

Sunshine Labs is poised to play a critical role in providing euGMP quality products to our partners around the world. Moving MDMA therapy forward is crucial to the health and well-being of our global community. We are pleased to be positioned to serve in this way.