Lykos Therapeutics was earlier this year denied approval for their MDMA formulation developed to treat post-traumatic stress disorder. The FDA advisory panel that rejected the application cited various issues as their basis, including sexual misconduct during the clinical trials, concerns about the drug’s potential for abuse, and a failure to submit data requested.
Soon after, Lykos let go of over 70% of its workforce.
Following these developments, Compass Pathways PLC (NASDAQ: CMPS) recently announced that it’d be delaying its phase III trial results reporting timeline to make certain that it could endure scrutiny associated with trial blinding. Compass Pathways, which has formulated a psilocybin treatment for depression, also revealed that it would be laying off almost one-third of its workforce.
Dr. Mwango Kashoki, Parexel’s global head of regulatory strategy, explained that these challenges were a reminder that biotechnology firms aren’t exempt from stringent regulatory examination. Parexel is an international clinical research organization and biopharmaceutical services firm.
However, Kashoki adds that if one psychedelic firm could cross this goalpost, it would be easier for others to do so. To help, Parexel has developed a road map guiding psychedelic firms on how to overcome these obstacles.
So, what does the road map contain?
For starters, Parexel emphasizes the need for firms to have open channels of communication with regulators. In particular, it recommends that firms engage with regulators in the early stages of development to provide insight for the future.
Kashoki adds that ensuring appropriate doses are selected for trials is also crucial. This, she explains, is because psychedelic trials carry safety risks. Exploring different dosing regimens can also allow sponsors to choose the most effective dose that has the least side effects.
Additionally, Parexel emphasizes the need for firms to take time when selecting doses instead of relying solely on clinical data. Here, Kashoki explains that companies need to conduct appropriate early-phase assessments to explore dose response from a physiologic, pharmacodynamic, and pharmacokinetic effects perspective.
Given that blinding researchers and subjects is still one of the biggest obstacles in trials for psychedelic treatments, Parexel also recommends that trials either administer comparative drugs with similar effects in the placebo group or recruit a blinded independent party to record effectiveness and safety data. This will help reduce the potential for bias.
In the report, Dr. Kashoki notes that if these concerns and considerations are sufficiently dealt with, then there will be no reason for the FDA to not consider the approval of these psychedelic treatments.
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