5 Key Takeaways

• 1

  Three psychiatric drugs approved by the FDA from 2013 to 2024 had more negative or failed efficacy trials than positive ones.

• 2

  The study evaluated 16 drugs for psychiatric conditions, analyzing trial design features and regulatory outcomes.

• 3

  Of 73 clinical trials submitted for FDA review, 45 (62%) were deemed positive by FDA reviewers.

• 4

  Three drugs, brexipiprazole, pimavanserin, and gepirone, had notably low rates of positive trial outcomes.

• 5

  Trial participants included 10,884 White, 5,328 Black, and 946 Asian patients, with nearly equal male and female representation.