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.
Kelun-Biotech's Phase III study of sac-TMT in combination with pembrolizumab meets primary endpoint
AstraZeneca signs global licence deal with Dizal for lung cancer drug Zegfrovy
Summit Therapeutics sells Phase III antibiotic asset ridinilazole to Biossil
European Commission approves Erbitux combination for first-line BRAF V600E-mutant mCRC
Servier acquires Edgewise Therapeutics' muscular dystrophy business
Takeda and Indonesia launch partnership to expand plasma-derived medicine production
HDT Bio Launches Canadian clinical programme for brain cancer treatment