Xenon pauses new enrollment in depression, bipolar disorder trials over side-effect concerns
XENE•Epilepsy program remains unchanged
Xenon said the pause does not impact its epilepsy program, and that it has submitted an application to the U.S. Food and Drug Administration seeking approval for the drug to treat focal seizures, the most common form of epilepsy.
Trials, drug details and next steps
Patients already enrolled in the trials will continue their treatment.
The studies are testing azetukalner, an experimental treatment that is also being developed for epilepsy.
Xenon noted that while the severity and frequency of the side effects aligned with how the drug worked, they had not appeared in an earlier mid-stage study for depression.
The company is now evaluating potential dose adjustments to help reduce the side effects and improve tolerability.
Xenon pauses new enrollment after side-effect reports
Sept. 17 (Reuters) - Xenon Pharmaceuticals on Thursday said it has temporarily paused enrolling new patients in clinical studies testing its experimental drug for major depression and bipolar disorder, following reports of mental and nervous system-related side effects.
Shares of the drug developer tumbled more than 20% in after-hours trading.
The voluntary pause was a precaution taken after consultations with its safety monitoring board and analyzing adverse events across the trials, Xenon said.
