SAN FRANCISCO, Sept. 29 (UPI) -- U.S. firm Vivus' topical drug Alista, a therapy for female sexual arousal disorder, will be retested in women who have had hysterectomies.
The manufacturers have already conducted a six-month long, double-blind, placebo-controlled study of Alista in 320 women who had developed FSAD after hysterectomy.
While the number of satisfactory sexual events in the group that received Alista doubled during treatment, those results did not differ significantly from the placebo group,
"The placebo response rate was higher than what was anticipated in the phase 2b trial," said Leland Wilson, Vivus' president and CEO. "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."
Wilson said that, until this problem is solved, Vivus will concentrate on three other drugs the company has in late-stage development: Qnexa for the treatment of obesity, Testosterone MDTS for hypoactive sexual desire disorder (HSDD), and Avanafil to treat male erectile dysfunction, all of which have demonstrated statistically significant benefits over placebo in phase 2 studies.
