Promising Milestone: FDA Approves California-Based Trial Assessing MDMA For Schizophrenia

The FDA has approved a clinical trial that will assess PharmAla Biotech Holdings' PMBHF proprietary LaNeo Investigational Medical Product (IMP) 40mg MDMA capsules for the treatment of schizophrenia. This is the first time these capsules will be tried on humans in the U.S

Expected to be conducted at UCLA in early September, the investigator-initiated open-label Phase 1 study will begin with 20 participants who will receive three doses - 40mg, 80mg and 120mg in ascending order.

PharmAla’s research VP Dr. Harpreet Kaur says that, while the company has had great success with regulators around the world, it’s still a major milestone to receive FDA approval for the company’s investigational drugs. 

“As with any IMP supplier, there are always questions about chemistry, manufacturing and control - even for well-known molecules. We believe that this announcement should confirm that our IMP conforms to the high levels of quality and documentation that one of the preeminent regulators in the world requires,” Dr. Kaur said.

CEO Nick Kadysh echoed the sentiment. “The FDA scrutinized our materials and processes in a rigorous but fair fashion.” He added that the company is willing to provide support to its research partner UCLA in upcoming trial permit applications to the DEA and Health Canada as they did with the FDA.

In addition to being the supplier of clinical-grade MDMA and psilocybin for several ongoing clinical trials, PharmAla’s own R&D unit has completed proof-of-concept research into its lead drug candidate, the novel MDMA analog ALA-002.

The company recently formed an Australia-based joint venture with Vitura Health for the distribution of the new medicines.

See also: Australia's Psychedelics Therapy Provides Hope For Treatment-Resistant Mental Health Conditions

Photo: Benzinga edit with photo by luchschenF and ANDREI ASKIRKA on Shutterstock.