Unlike its independent panel, the agency saw a need for at least one non-hormonal drug to reduce a common menopausal symptom, and the new drug, called Brisdelle, is the first. “There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,” Dr. Hylton Joffe, a director in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Gynecologists have been prescribing antidepressants such as paroxetine for years off-label to help alleviate night sweats and hot flashes in women plagued by sleepless nights. “The most effective treatment we have is estrogen, but in my experience, antidepressants can help a little bit,” said Dr. Isaac Schiff, chair of gynecology at Massachusetts General Hospital.
Paroxetine is typically prescribed in doses ranging from 20 to 50 milligrams per day to treat clinical depression, but the new drug contains just 7.5 milligrams, to be taken once a day at bedtime.
Antidepressants for hot-flash relief may be most useful for breast cancer patients who often can’t take estrogen drugs because they’re associated with an increased breast cancer risk.
But Brisdelle shouldn’t be prescribed to certain breast cancer patients who are taking tamoxifen because it may reduce the cancer drug’s effectiveness, according to the FDA. Schiff said in those cases he may prescribe the antidepressant venlafaxine (Effexor), which doesn’t interfere with tamoxifen but hasn’t been approved for hot-flash relief.
In clinical trials to test Brisdelle’s effectiveness, the drug was found to reduce the number and severity of hot flashes compared with a placebo, but the difference was small: fewer than two hot flashes per day. Women had to experience at least seven hot flashes a day to be included in the studies, so a reduction down to five isn’t all that significant.
While Schiff said there can be a strong placebo effect to any treatment used to reduce hot flashes, he said that he’s glad Brisdelle was approved and that he would be likely to prescribe it over the higher-dose generic paroxetine.
Its lower dose and likely insurance coverage may make it a better option for patients, though the brand name will likely cost more than the generic. Whether patients wind up paying less out of pocket for Brisdelle than for generic paroxetine remains to be seen. But sexual side effects such as loss of libido may be less common with the lower-dose Brisdelle.
Another upside for antidepressants: They can be taken for years or even decades to help control hot flashes unlike hormone therapy, which doctors don’t recommend using for more than five years because of its association with breast cancer and other health risks.