Vivus completes protocol assessment for Phase III studies of Luramist

Under the special protocol assessment (SPA), the company and the FDA have agreed to design features for the pivotal Phase III efficacy studies including the primary endpoints, the scope and size of the patient population to be studied, inclusion/exclusion criteria, duration of the trials and elements of the statistical analysis plan. The pivotal Phase III program will include two double-blind, placebo-controlled trials that will enroll menopausal women for six months of treatment. The primary endpoints in the clinical trials are an increase in sexual desire and the number of satisfying sexual events, with a secondary endpoint of a decrease in sexual distress.

In addition to the two pivotal Phase III efficacy trials, company has reached agreement with the FDA on the safety study. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular event-based outcomes study. The study will enroll approximately 5,200 women, aged 50 years or older, who have at least one cardiovascular risk factor.

Leland Wilson, president and CEO of Vivus, said: “The agreement with the FDA and the clarity on the safety requirements as evidenced by the written minutes and responses from the FDA will allow us to move forward in the development of this important therapeutic. There are no approved therapies for hypoactive sexual desire disorder (HSDD) and we believe women will prefer the transdermal spray over other drug delivery systems for testosterone.”