Patent granted for first new forms of MDMA, clearing path to a potential FDA approval

Key takeaways:

• The FDA is currently reviewing MDMA HCI for approval and a decision is expected in August.
• Terran Biosciences will pursue a rapid approval pathway for its patented new form of MDMA, pending the FDA decision.

Terran Biosciences has been awarded a U.S. patent for the world’s first new salts and polymorphs of MDMA, pharmaceutical compositions using these forms, and the method of use for treatment of PTSD, according to a company press release.

Terran Biosciences now holds the only composition of matter patent of a new form of MDMA, according to the release.

To date, clinical trials of MDMA have been limited to using older forms of MDMA hydrochloride (MDMA HCI). MDMA HCI was submitted for FDA approval on the 505(b)(1) path and is currently under review. A decision is expected in August. If the FDA approves MDMA HCI, Terran Biosciences said it will pursue a rapid 505(b)(2) approval pathway for its new form of MDMA (MDMA hemifumarate).

Terran Biosciences could use this regulatory pathway to bring its MDMA product to market approximately 5 years from the date of the MDMA HCI approval. This would involve leveraging existing safety and efficacy data from completed MDMA trials to bypass any listing in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for the older MDMA HCI.

The company said in the release that it hopes to increase the affordability and global accessibility of MDMA, and that it has developed a new GMP manufacturing process with this goal in mind.

“With this new breakthrough, we are committed to bringing affordable and accessible MDMA treatment options to patients with PTSD,” Sam Clark, MD, PhD, inventor of the patent and Terran Biosciences’ founder and CEO, said in the release. “We believe this new form of MDMA will enable us to bypass any potential future Orange Book listing, eliminating the potential for a 30-month stay that could otherwise delay the entry of generic MDMA HCl. MDMA-assisted psychotherapy could revolutionize the treatment of PTSD and Terran Biosciences will ensure that affordable MDMA is not delayed.”