Lykos Therapeutics Releases Statement on FDA Advisory Committee Meeting

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On June 4, the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted against the approval of MDMA-assisted therapy for the treatment for posttraumatic stress disorder (PTSD).¹ Lykos Therapeutics released a statement to provide additional insights on the outcome of this meeting.² 

“While we were of course disappointed by the outcome, we were not surprised by the important questions raised. We are advancing a novel treatment and have worked closely with the FDA over the course of years to address these complex issues. Ultimately, the final decision for the potential approval of midomafetamine rests with the FDA, and we are deeply committed to providing any information needed to enable its thorough review. We have full confidence in the rigor and thoughtfulness that the FDA will give our application,” said Amy Emerson, the CEO of Lykos Therapeutics.²

Emerson shared the company’s perspectives on issues raised by the committee, such as functional unblinding, cardiovascular and hepatotoxicity risks, and therapist misconduct.

One of the core concerns of the committee was the lack of blinding, which is a challenge for psychiatric treatments with psychoactive effects. Emerson assured readers that the phase 3 trial design was discussed extensively with the FDA during the 2017 Special Protocol Assessment process. She also stressed that Lykos took steps to minimize the impact of the functional unblinding by using independent, blinded third-party clinician raters.

As to the cardiovascular and hepatotoxicity risks, Lykos pledged to work further with the FDA to evaluate the data or collect new data to address potential risks.

The committee was distressed by accusations of therapist misconduct. Emerson agreed that the 2015 phase 2 trial incident was “a terrible and harmful instance of malpractice that caused profound suffering to a participant,” but she assured readers that Lykos reported the violation to Health Canada, the FDA, and the relevant Institutional Review Board. Additionally, the therapist pair was banned from all future work. They then developed new policies to prevent and encourage reporting of similar instances of unethical behavior.

Other concerns addressed included: evidence of effectiveness, prior MDMA use, psychological intervention in research protocol, regulation of psychological intervention, and sponsor and investigator bias.

“Over the coming weeks, we will continue to collaborate with the FDA and will answer all questions they have to help inform their decision-making process. Misinformation has been circulated about our program, and we want to clarify that the FDA has received all data and supporting documentation. It is our hope that this letter provides a useful summary that is responsive to some of the most commonly asked questions,” wrote Emerson. “We continue to deeply appreciate the profound support of all those stakeholders who are committed to improving outcomes for those suffering from PTSD. Unfortunately, effective treatment options remain limited for the millions of people who suffer every day.”²

The final decision on Lykos’ application will come on August 11, 2024.

References

1. Kuntz L. FDA panel votes against MDMA-assisted therapy. Psychiatric Times. June 5, 2024. https://www.psychiatrictimes.com/view/fda-panel-votes-against-mdma-assisted-therapy

2. Lykos Therapeutics Statement on FDA Advisory Committee Meeting. Lykos Therapeutics. June 13, 2024. https://news.lykospbc.com/2024-06-13-Lykos-Therapeutics-Statement-on-FDA-Advisory-Committee-Meeting