FDA Rejects Two Menopause Drugs Deemed Ineffective
March 6, 2013

FDA Rejects Two Menopause Drugs Deemed Ineffective

redOrbit Staff & Wire Reports - Your Universe Online

A Food and Drug Administration (FDA) advisory committee rejected on Monday two proposed menopause drugs designed to reduce the frequency and severity of hot flashes.

In a 12-to-2 vote, the advisory committee for reproductive health drugs voted against approving Depomed´s extended-release gabapentin, known as Sefelsa, which contains a form of an active ingredient used in some anti-seizure medicines. It also rejected in a vote of 10-to-4 Noven Pharmaceuticals´ low-dose formulation of the antidepressant paroxetine.

The panel said its decision was based primarily on concerns the medicines did not appear effective.

The two drugs had been vying to be the first non-hormonal hot-flash treatments to receive FDA approval.

Committee members acknowledged the need for new drugs, but said both medicines offered only marginal benefits, reducing the number of hot flashes by only about one per day compared with a placebo.

The FDA is not required to follow the advice of its advisory panels, but it would be highly unusual for the agency to approve a drug after such a resounding committee vote against it.

More than half of menopausal women experience hot flashes, also known as vasomotor symptoms, which are characterized by warmth, flushing and sweating.

The hormone estrogen, or the combination of estrogen and progestin, is typically considered the most effective treatments for hot flashes. However, the use of these hormone therapies has plummeted since the 2002 Women´s Health Initiative study, which suggested that the combination of estrogen and progestin increased a woman´s risk of heart attack, stroke and breast cancer.

In a statement, Depomed said it would halt all spending related to the development of Sefelsa as a result of the committee vote.

Joel Lippman, Noven's executive vice president, said in a statement that the company still believes paroxetine is a safe and effective non-hormonal option for menopausal women, and "would work closely with the FDA as its [sic] completes its ongoing evaluation."

The FDA noted that clinical data examining the effectiveness of the two drugs in reducing the frequency and severity of hot flashes were mixed, and fell short of meeting the required study goals.

In the case of gabapentin, the FDA said three studies failed to show a reduction in the frequency of hot flashes at 12 weeks of treatment. And while the study did show a reduction in the severity of hot flashes, it "varied considerably across studies," the FDA said.

Two clinical studies involving paroxetine showed reductions in the frequency of hot flashes, while a reduction in severity was observed in just one of the two studies.

In documents released by the FDA ahead of the vote, both companies said additional non-hormonal treatments are needed to treat the symptoms of menopause.

Gabapentin and some antidepressants are already used by some doctors to treat hot flashes, despite the medicines lack of approval for that use.

At this point, the only FDA-approved drugs to treat hot flashes and menopausal symptoms are hormones. In such cases, the agency has advised doctors to prescribe the lowest possible dose for the shortest amount of time.