Vivus endocrine/metabolic news

Vivus plans to reduce contractual sales representatives for obesity drug Qsymia phentermine/topiramate to about 100 from about 150. The company said it will further invest in “consumer-focused digital media projects” to raise awareness about obesity and Qsymia, including web-based patient outreach. Vivus declined to provide specific guidance around anticipated savings. As of Feb. 6, Vivus had 94 employees, excluding the contractual Qsymia sales representatives.

Additionally, Vivus plans to discuss with FDA cost-saving alternatives for the planned Phase IV AQCLAIM cardiovascular outcomes trial of Qsymia, but declined to disclose details on potential alternatives. In February, Vivus quoted that the AQCLAIM study will cost about $180-$200 million over five years. The company said it will not have a timeline for the start of AQCLAIM until it completes discussions with FDA. Vivus previously modified the design of the CV outcomes trial to support a potential pathway for EU approval and has been in discussions with FDA to ensure an interim analysis would not jeopardize the integrity of the trial. ...