Monday the FDA failed to approve two new medications for hot flashes. The Advisers for the FDA felt the benefits did not sufficiently outweigh the risks. The first medication was for a drug made by Depomed Inc, which failed 12 to 2.
The panel also voted 10-4 against approving a drug for hot flashes made by Hisamitsu Pharmaceutical Co Inc’s subsidiary Noven Pharmaceuticals Inc.
This is really unfortunate because there are currently no prescription alternatives for hot flashes that are approved by the FDA. I covered the presentations of these medications at the North American Menopause Society meeting last October and although I did not have access to all the data, the presentations I heard seemed to be fairly favorable and both medications seemed like great options for women who could not take estrogen or who didn’t want to take them for fear of heart attack or stroke.
Since three fourths of women have hot flashes and since there are over 30 million women in menopause, there are a lot of women who would have benefited from another option. The unfortunate thing in particular is that both of the meds that failed are on the market at various dosages for treatment of other conditions and both are currently used off label anyway. The newer versions would have been more tailored to hot flashes as to dosage.
One of the reasons for failure was a prior study that showed an increased risk of suicide among users of gabapentin and paroxetine. No question this is a concern that must be taken seriously, but the study raised concerns that need to be further investigated.
Another concern was that the hot flashes got better but the women who received placebo also improved somewhat. That is in fact common in short duration studies of hot flashes and it is too bad that finding was used against approval of the medications.
Many of the side effects of these meds and in particular Gabapentin, went away by the end of a week or so and only about 3% of women continued to complain of dizziness. One of the side effects, sleepiness, could have been used as a plus if the medication were taken at bedtime. Sleep affects so many women in menopause. You can click here for a FREE SLEEP DIARY to use to talk with your doctor about sleep issues.
Depomed’s drug, Sefelsa, is a long-acting version of the epilepsy drug gabapentin. A short-acting version of gabapentin, made by Pfizer Inc and marketed as Neurontin, was approved in 1993.
Clearly, safety is a major and first priority for a medicine to be approved. But it is unfortunate that two drugs currently approved for multiple other indications could not be made available for this very common and troublesome symptom of hot flashes in women entering menopause and beyond.
Depomed said it would cease spending on Sefelsa (gabapentin).
Noven’s drug comprises a low dose of the antidepressant paroxetine mesylate. The company sells a higher-dose version of the drug under the brand Pexeva that is used to treat depression, obsessive-compulsive disorder and generalized anxiety.
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