• by Les Luchter , Staff Writer, September 19, 2024

The antonym of “ecstasy,” according to Oxford, is “misery.” And that’s how most of the emerging psychedelic drug industry felt in early August when the Food & Drug Administration (FDA) rejected Lykos Therapeutics’ application to have MDMA, aka ecstasy, approved as a treatment for post-traumatic stress syndrome (PTSD).

Within a week, the 10-year-old company announced it was laying off 75% of its employees as it works to resubmit its application to address the FDA’s concerns.  Then, in early September, Lykos’ founding chief executive officer, Amy Emerson, stepped down, with chief operating officer Michael Mullette, formerly of Sanofi and Moderna, replacing her on an interim basis.

Lykos is also stepping back from support of investigator-initiated trials (IITs), creating an opening for Canadian company PharmAla Biotech to fill the gap.

Not that PharmaAla is new to supplying MDMA for clinical trials. Launched three years ago as an early stage drug discovery program, PharmAla jumped into MDMA production precisely because of the need for the drug by those doing clinical trials, Nicholas Kadysh, PharmAla’s founding chief executive officer, tells Pharma & Health Insider.

Just last week, PharmAla announced it would supply MDMA to a clinical trial at Johns Hopkins Medicine, an arrangement Kadysh says was in the works before Lykos’ downsizing. He adds that PharmAla is now supplying MDMA to about 15 trials worldwide, with some three of four in the U.S. Other opportunities, he says, are coming the company’s way because of Lykos’ retrenchment, with the firm now speaking to a “large number” of researchers. He points out that either the Veterans Administration or the Department of Defense are funding several of these.

Perhaps ironically, though, PharmAla has no plans to enter the U.S. market.

The company, instead, is “focused on the pharmaceutical market outside of the U.S.,” and already selling MDMA on a limited commercial basis for PTSD in both Canada and Australia. Kadysh says he hopes to have the Netherlands on board as well by the end of the year.

Besides PTSD, other neuropsychiatric  mental health applications being studied for MDMA include social anxiety and schizophrenia, for which PharmAla is involved in a UCLA trial.

On the marketing front, “the next step for us in Canada and Australia is physician education…either CME (continuing medical education) or CPD (continuing professional development),” Kadysh says. “We hope to have something to announce on that front very, very shortly.

“There’s a lot of appetite for novel psychiatric treatments,” he states. “There’s not a lot out there, but the first step is making sure physicians have the ability to educate themselves and assess whether this is right for their patients or not.”

Consumer marketing will not be in the mix, Kadysh says. “Frankly, it’s a little bit inappropriate for a pharmaceutic company to go directly to consumers for a product like this,” he declares. “It’s still in the very early stages.”

But MDMA is coming, even in the U.S.

“The train has left the station already” Kadysh says, “because you have two countries where patients are being treated, and it’s gone very well.”