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First MDMA prescriptions likely in December

Manufacturing News

The first prescriptions for MDMA, better known as a party drug but now available to patients, could be available for supply to Australians as early as December following news from medicinal cannabis producer Vitura Health that it is preparing the drug for sale.

The company told investors that its Cortexa joint venture with PharmAla Biotech had landed the bulk active ingredient of MDMA (3,4-methylenedioxy-methamphetamine) into Australia and it was now being prepared to be batch manufactured into finished dosage forms.

MDMA and psilocybin — the active ingredient in magic mushrooms — are both psychedelic substances.

However they were were reclassified by the Therapeutic Goods Administration in July to allow them to be prescribed by psychiatrists to treat patients with post-traumatic stress disorder and treatment-resistant depression.

Vitura CEO and Executive Director Rodney Cocks said: “We are extremely proud to have landed MDMA product in bulk and patient ready capsule form into Australia for clinical and research prescription.

“By the end of November 2023 we also expect to have landed bulk psilocybin GMP product also for clinical and research prescription.

“This paves the way for the first expected clinical patients vis the TGA’s authorised prescriber scheme access pathway in December, 2023.”

Cocks, a veteran, said MDMA could now be authorised by psychiatrists to some of the most vulnerable in the community, including veterans and first responders.

“We look forward to supporting those who have given so much to Australia.”

The majority of the first shipment of MDMA is to satisfy demand under existing supply agreements made by the company, including for university trials.

Cocks held open the possibility of manufacturing the active ingredients for MDMA and psilocybin in Australia as demand increases, utilising intellectual property from PharmAla Biotech.

“This valuable optionality allows for Cortexa to avoid costly and time-consuming importation activities and underpins future domestic supply for patients and clinical trial participants.

“We will continue to monitor the market for the right time to onshore manufacturing as demand scales.”

Picture: Vitura Health

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