Menopausal women looking for an approved alternative to hormones to treat hot flashes will probably not be getting immediate relief.
Outside advisers to the Food and Drug Administration on Monday soundly rejected two drugs vying to become the first nonhormonal hot-flash treatments to win the agency's approval.
The advisory committee for reproductive health drugs voted 12 to 2 against approving Depomed's extended-release gabapentin. It also voted 10 to 4 against a low-dose formulation of the antidepressant paroxetine developed by Noven Pharmaceuticals.
Committee members, while acknowledging the need for new drugs, said both medicines offered only marginal benefit, reducing the number of hot flashes by only about one a day compared to a placebo.
The F.D.A. does not have to follow the advice of its advisory panels. But it would be highly unusual for the agency to clear a drug after a strongly negative committee vote.
More than half of women going through menopause experience hot flashes, also known as vasomotor symptoms. The sudden feeling of heat, often with sweating, can disrupt sleep, relationships and daily activities.
The hormone estrogen or the combination of estrogen and progestin are considered the most effective treatments. But use has decreased sharply since a 2002 study known as the Women's Health Initiative suggested that the combination of estrogen and progestin raised the risk of cardiovascular problems and breast cancer.
Some doctors and patient advocates told the committee that there was an urgent need for options for women who now cannot or will not use hormones. Many such women resort to herbal supplements or other therapies that have not been proved to work, they said.
Women "are begging for alternatives," Dr. Andrew London, an obstetrician and gynecologist in the Baltimore area, told the committee, which met in Silver Spring, Md. If there were no approved drugs, he added, "They will get help on their own without us."
But the committee members were not convinced that the benefits of these two drugs outweighed the risks, even though both drugs have long been used for other diseases and their risks are well known.
"The risk of medications cannot be ignored for a treatment of marginal effectiveness," Dr. Julia V. Johnson, chairwoman of the meeting and a professor of obstetrics and gynecology at the University of Massachusetts Medical School, said of gabapentin.
Some committee members also said that since versions of both drugs were already approved for other uses, doctors could prescribe them off-label for hot flashes. Many doctors do already.
Gabapentin was first approved in 1993 as a treatment for epilepsy, sold under the name Neurontin by Warner-Lambert, which was later acquired by Pfizer. Depomed already sells an extended-release formulation of gabapentin under the name Gralise as a treatment for postherpetic neuralgia, which is lasting pain caused by shingles.
Depomed, which is based in Newark, Calif., planned to call its hot-flash version Sefelsa. Depomed shares fell 9.8 percent, or 64 cents, to $5.89 after the committee's vote.
"Based on today's meeting we believe the hurdles for approval of a nonhormonal treatment for hot flashes remain high," Jim Schoeneck, chief executive of Depomed, said in a statement. "Until we believe there is a positive direction for Sefelsa, we will cease all spending relating to the product candidate."
Dr. Joel S. Lippman, chief medical officer of Noven, said the company was disappointed and believed it had demonstrated that its drug would be "a safe, effective, nonhormonal treatment option."
Paroxetine is the active ingredient in GlaxoSmithKline's antidepressant Paxil, which was first approved in 1992.
Noven, an American subsidiary of the Hisamitsu Pharmaceutical Company of Japan, was seeking approval of a lower dose of paroxetine than typically used for psychiatric ailments.
The basic problem, however, for both Depomed and Noven was that women taking placebos in the trials experienced a substantial reduction in hot flashes that the drugs could not beat in any pronounced way.
Women in three Depomed trials started with an average of more than 11 episodes a day. After 12 weeks of treatment, the average had dropped by more than seven episodes a day for those getting gabapentin. But it dropped by more than six episodes a day for those taking a placebo. The difference was not statistically significant in any of the trials.
Noven's drug did reduce frequency in two trials by statistically significant amounts. But most committee members said the extra reduction — 0.9 of a hot flash episode a day in one trial and 1.7 episodes in the other — would not be clinically meaningful to women.
While side effects are well known, some panel members were concerned about dizziness for gabapentin and suicidal thoughts for paroxetine.
Last week, the F.D.A. approved a treatment for another symptom of menopause — pain during sex caused by the thinning and drying of vaginal tissue. The drug, a once-daily pill called Osphena or ospemifene, will be sold by the American unit of Shionogi, a Japanese company.
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