Optimi Health Corp (NASDAQ:OPTH) (CSE:OPTI) (FSE:8BN0), a commercial-stage GMP pharmaceutical manufacturer of regulated psychedelic drug products, announced on Tuesday that it has completed production of two microdose psilocybin finished drug products, formulated at 1 mg and 2 mg dosages.
Available to qualified, authorised clinical research organisations, the products provide the consistent, validated doses required for controlled studies.
Microdosing refers to taking low, sub-perceptual doses of a psychedelic on a repeated schedule. Common regimens include the Fadiman protocol (one day on, two days off) and the Stamets protocol (four days on, three days off), which build in rest days to limit tolerance.
CEO and co-founder Dane Stevens said: "Most microdosing relies on dried mushrooms, whose psilocybin content varies widely from batch to batch. Optimi's capsules instead deliver naturally derived psilocybin at a validated, consistent dose, pairing the natural source many researchers prefer with the accurate dosage that controlled research requires. The 1 mg and 2 mg dosage formats extend Optimi's psilocybin range, which already includes the 5 mg capsule formulation currently prescribed for treatment-resistant depression in Australia."
Optimi produces these products completely in-house, cultivating and harvesting the mushrooms, generating a full-spectrum mushroom extract as the active pharmaceutical ingredient (API), and formulating, encapsulating, and packaging the finished product for export to clinical research organisations. Every stage is completed on-site at Optimi's wholly owned GMP facility in Princeton, British Columbia, Canada, under its Health Canada Drug Establishment License (DEL).
Optimi supplies finished psilocybin and MDMA drug products to regulated markets internationally.
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