FDA panel rejects non-hormonal menopause treatment

fda logo FDA panel rejects non hormonal menopause treatmentAn experimental non-hormonal treatment for menopause was rejected by a Food and Drug Administration advisory panel this week because the group found risks associated with the drug were greater than any benefit it offered.

Drug maker Depomed submitted for approval Seflsa, known generically as gabapentin, a medication that has long been used to treat pain and seizures. It is also prescribed off-label by doctors to treat menopause symptoms. Depomed asked the FDA to approve this use, which would allow the company to market it as a menopause treatment.

The panel’s decision to vote against approving Seflsa is based on studies that the group said failed to show significant reduction in hot flashes over 12 weeks. Patients also experienced side effects such as dizziness, fatigue and balance problems. The drug already carries a warning that it can increase the frequency of suicidal thoughts.

Drug regulators are already skittish about approving drugs to treat menopause after studies showed hormone replacement therapy (HRT), which was widely used prior to 2002 for the treatment of menopausal symptoms, put women at greater risk for heart disease, stroke and breast cancer. Since then, HRT sales have dropped significantly leaving a gap in the market for safe and effective remedies for hot flashes, mood swings, vaginal dryness and other symptoms associated with menopause.

The FDA is not required to follow the recommendations of its advisory panel, but it usually does. Even if Seflsa is ultimately rejected by the FDA, doctors can still prescribe the drug off-label to treat menopausal symptoms.

Source: NBC News