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Toronto-based MDMA manufacturer PharmAla Biotech signed a contract to supply researchers at McLean Hospital, an HMS-affiliated psychiatric teaching hospital, with the drug for a pending clinical trial, PharmAla announced in a Oct. 2 press release.

If the trial receives grant funding, the contract will require PharmAla to provide MDMA — in exchange for an undisclosed sum — for a study on the mechanistic effects of MDMA in individuals with borderline personality disorder.

“Borderline personality disorder is a complex disorder with heterogenous symptomology, and as such, could benefit from different treatment options in addition to evidence-based treatments like psychotherapy,” Jenna M. Traynor, the principal investigator on the research grant, wrote in a Wednesday statement.

Nicholas Kadysh, the CEO of PharmAla, wrote in a Monday email that the use of MDMA in clinical research on mental illness is rapidly expanding.

“We are seeing a massive amount of interest in studying its use to treat other disorders (Neuropathic pain, anxiety disorders, couples dysfunction), and in very diverse populations,” Kadysh wrote.

According to Kadysh, PharmAla has been contracted to supply MDMA to a large number of academic institutions, including the University of Sydney and the University of Melbourne, in Australia, and the University of California system.

The researchers expect to hear a decision on funding in the next year, according to Traynor.

Due to MDMA’s classification as a Schedule I drug — one of the most federally regulated substances — researchers must pass through additional hoops to get their trial off the ground, including obtaining licenses from both the U.S. Food and Drug Administration and Drug Enforcement Administration.

Because PharmAla is a Canadian company, the researchers also need an import permit from the DEA to use their product, according to Kadysh. On the supply end, PharmAla must apply for its own export permit from Canadian regulator Health Canada.

In all, the process of getting approved “can take up to three months,” Kadysh wrote.

He added that PharmAla supports researchers through the process with a “customer-centric approach.”

“Planning a clinical trial is already plenty hard,” he wrote. “If there are any problems along the way, we attempt to help as much as we can — and of course, we stand behind our products.”

Traynor, who has previously researched the use of MDMA-assisted psychotherapy for BPD, wrote that the team hopes to see if the MDMA approach is one that merits future study.

“In our research, we hope to explore the feasibility and scientific mechanisms such a treatment may have for individuals with BPD, to see if this approach is one to pursue in future trials,” she wrote.

Correction: October 10, 2024

A previous version of this incorrectly stated in the headline and the body of the article that the clinical trial was being conducted by the Harvard Medical School. In fact, the clinical trial is being conducted by McLean Hospital, an HMS-affiliated psychiatric teaching hospital.