In this study, patients with FSAD using Alista achieved a more than doubling over baseline in the number of satisfactory sexual events; however, the difference between the Alista treatment group and the placebo group did not achieve statistical significance for the primary endpoint of the study.
During study participation, subjects maintained daily diaries to capture outcomes of all sexual encounters, and the primary measure of treatment efficacy was based on the difference between Alista and placebo in the improvement over baseline in the number of satisfactory sexual encounters per month.
Vivus said that additional work would be required to determine how to better control the placebo response rate in this patient population before additional clinical trials can be started.
The company also stated that Alista would not be a priority in its development efforts as they had other products in their pipeline in late stage clinical programs. These products include Qnexa for the treatment of obesity, testosterone MDTS for the treatment of hypoactive sexual desire disorder and avanafil for the treatment of male erectile dysfunction which have so far met targets in clinical trials.