Drugs

Tonix Changes Tonmya Phase 3 Study

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 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome