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# Tonix Changes Tonmya Phase 3 Study
- URL: https://www.fdaweb.com/tonix-changes-tonmya-phase-3-study/
- Published: 2019-11-04T12:00:00.000Z
- Updated: 2026-09-14T15:51:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145408

Tonix Pharmaceuticals says that for its Phase 3 study of Tonmya (cyclobenzaprine sublingual tablets) to treat post-traumatic stress disorder (PTSD), the timing of the primary endpoint analysis has been changed from week 4 to week 12\. The company also [says](https://www.marketwatch.com/press-release/tonix-pharmaceuticals-announces-12-week-primary-endpoint-and-addition-of-adaptive-design-features-in-the-currently-enrolling-phase-3-recovery-study-of-tonmyar-for-ptsd-following-fda-meeting-2019-11-04-7184052?ref=fdaweb.com) it plans to add an interim analysis that allows for a potential sample size adjustment, based on guidance from its recent meeting with FDA officials.

“The Phase 3 study design changes are being implemented after FDA indicated the importance of showing persistence of treatment effect at week 12 in a pivotal study,” the company says.

The RECOVERY Phase 3 study is described as a 12-week randomized study for treating civilian and military-related PTSD. Enrollment is restricted to participants with PTSD who experienced an index trauma within nine years of screening.