Boadie Dunlop, MD, Reacts to the FDA Advisory Committee Meeting Vote on Lykos’ MDMA

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Dunlop provided his opinions on the committee’s comments regarding functional unblinding and cardiovascular implicative risks when it comes to studying MDMA.

Last month on June 4, 2024, the US Food and Drug Administration (FDA) Psychopharmacologic Advisory Committee (PDAC) voted 2-9 against supporting the effectiveness of MDMA to treat adult patients with PTSD. Although the vote was not promising, it is not over yet for MDMA. The FDA will make its final decision on Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted psychotherapy to treat adults with PTSD by August 11, 2024.

Directly after the PDAC meeting, HCPLive covered a live report with Franklin King, MD, from Massachusetts General Hospital to give reactions and discuss the decision. Later in the month, HCPLive spoke with expert and vested stakeholder in the space, Boadie Dunlop, MD, professor of psychiatry and behavioral sciences at Emory University School of Medicine, regarding arguments the committee said during the meeting.

One of the conversations at the meeting centered on safety and the cardiovascular implicative risks. With post-dosing effects, patients can leave the clinic and experience psychological vulnerability such as a decline in mood as serotonin levels are resolving. Dunlop told HCPLive it is important for a trusted family member or friend to be with them after dosing and then to follow up the next day.

“We need to recognize the power of these drugs, and a drug that is powerful also typically has the power to potentially induce harms, and that will need close monitoring,” Dunlop said. “I don't see these as insurmountable problems. I see them as a new space for psychiatry to require a special monitoring.”

Committee members also said it is impossible to avoid a functional unblinding when it comes to testing MDMA-assisted therapy. In the live report, King suggested maybe they could compare a lesser dose of MDMA as a control instead of a placebo, but Dunlop said Lykos Therapeutics considered doing this but decided against it due to its “deleterious effect.”

“It might be actually worse than an inert placebo, and so you'd be comparing high dose versus low dose, and actually enhancing the likelihood, compared to an inert placebo, that the high dose would show efficacy,” Dunlop said.

Functional blinding is not a new thing. The drug quetiapine, approved to treat bipolar disorder and an adjunctive agent for depression, anxiety, and schizophrenia, is functionally unblinding, with patients being able to tell they are getting sedated at 50 mg. The issue of functional blinding was brought up in studies, but Dunlop said if it had undergone the same level of scrutiny for functional binding, quetiapine might not have been approved.

“The idea that the efficacy measures of a drug should be discarded, thrown out because there's functional blinding threatens a lot of what these drugs in psychedelics and MDMA can offer, and we are seen to be holding it to a higher standard or a new bar compared to past drug approvals,” Dunlop said.

References

Kunzmann, K. FDA Psychopharmacologic Advisory Committee Votes Against Supporting Effectiveness of MDMA for PTSD. HCPLive. June 4, 2024. https://www.hcplive.com/view/live-updates-fda-psychopharmacologic-advisory-committee-meeting-mdma-ptsd. Accessed July 2, 2024.


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