FDA panel votes no on testosterone patch.(News)

GAITHERSBURG, MD. -- A federal advisory panel unanimously recommended against approval of a testosterone patch for treating hypoactive sexual desire in surgically menopausal women on estrogen therapy, calling for more long-term safety studies and the completion of ongoing trials of the patch in naturally menopausal women.

At a meeting of the U.S. Food and Drug Administration's Advisory Committee for Reproductive Health Drugs, the majority of the 17-member panel agreed that the data on the effectiveness of the patch showed that it had a "clinically meaningful benefit," compared with placebo in this group of women.

Several panelists commented that the effect was marginal. Women reported having a mean increase of one satisfying sexual event every 4 weeks, compared with those wearing a placebo patch, which was a statistically significant difference. There also were significant improvements in the secondary end points of sexual desire and personal distress.

All panelists agreed that the safety database, which included data on almost 500 women treated for 12 months with the patch and concomitant estrogen, was not adequate to demonstrate long-term safety. There were no placebo-controlled safety data for longer than 6 months of use. Major concerns included the impact the patch might have on breast cancer risk and cardiovascular disease (CVD), and the likelihood that the patch would be used off label in naturally menopausal women and premenopausal women.

The patch, manufactured by Procter & Gamble Pharmaceuticals, is the first product reviewed by the FDA for a female sexual dysfunction indication. The proposed trade name for the patch is Intrinsa. In trials, the patch, which delivers 300 mcg of testosterone a day, was applied to the abdomen and replaced twice a week.

Panelist Charles Lockwood, M.D., chair of the obstetrics and gynecology department at Yale University, New Haven, said that safety concerns that had not been addressed were the patch's venothrombotic effects, its impact on women who become pregnant while wearing the patch, whether the patch increased breast cancer risk, and the effects of fetal exposure.

Cardiovascular disease is the leading cause of death in postmenopausal women, so even a very small increase in this risk would "represent a huge burden of morbidity," said Steven Nissen, M.D., of the Cleveland Clinic Foundation, who was the cardiologist consultant on the panel. He added that while he was not "devaluing the importance" of hypoactive sexual desire, he questioned whether an increase in one more satisfactory sexual experience per month was worth the potentially increased risks of cardiovascular disease.