VIVUS Announces Results Of ALISTA Phase 2b Study; Drug Fails Study

MOUNTAIN VIEW, Calif., -- VIVUS, Inc. , today announced results of the company's Phase 2b clinical study of its investigational drug ALISTA(TM) (topical alprostadil), for the treatment of female sexual arousal disorder (FSAD), in women who have undergone a hysterectomy. In this double-blind, placebo-controlled 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. Following a 2-month non-treatment run-in period, 320 subjects were randomly assigned to treatment with ALISTA or placebo for a period of 6 months. 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. This was the first study in which the efficacy of ALISTA was prospectively evaluated in an all organically impaired group of patients with FSAD.

"The placebo response rate was higher than what was anticipated in this phase 2b trial," said Leland Wilson, president and CEO of VIVUS. "Additional work will be required to determine how to better control the placebo response rate in this patient population before additional clinical trials can be started. Because we have a rich pipeline with three late-stage development programs, ALISTA will receive a lower development priority at VIVUS. We will focus our development efforts on Qnexa for the treatment of obesity, Testosterone MDTS for the treatment of hypoactive sexual desire disorder (HSDD) and avanafil for the treatment of male erectile dysfunction (MED), all of which have demonstrated clear, clinical and statistical significance over placebo in phase 2 studies."

I put this up for the simple reason that the people that received placebo may have even had a higher response. The mind is a very powerful thing! It reminds me of winter colds and people that drink tons of vitamin c, zinc etc. If you think that helps to make you feel better, it will. They have an interesting pipeline, Will keep an eye on this company.

Vivus trades on the NASDAQ: VVUS and was down at friday's close 23 cents to $3.70.