Canadian drug company eyes FDA approval in 2024
Psychedelic drug researcher and formulator Optimi Health Corp. said Jan. 19 that Health Canada has amended a permit that allows the company to substantially increase production of MDMA in anticipation of FDA approval in 2024.
The amendment, implemented on Jan. 16, will allow the Canadian drug manufacturer to increase MDMA production from 2 kg to 20 kg as well MDA production from 1 kg to 2 kg and 2C-B production from 400 g to 4 kg.
2C-B is a psychedelic that is structurally similar to mescaline. Both MDA and MDMA belong to the phenethylamine class of drugs.
MDA is said to have more stimulating and psychedelic effects.
“This marks a pivotal achievement in Optimi’s strategic licensing plan, positioning us with one of the most robust licensing portfolios globally, said Bill Ciprick, Optimi’s CEO. “It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances.”
In its year-end annual review, the company established its 2024 strategic licensing plan, which includes approvals for a drug master file and drug-establishment license. These steps demonstrate the company’s adherence to regulatory compliance, good manufacturing practices and transparency, including streamlined communication with regulatory officials, the company said.