Staff members from the U.S. Food and Drug Administration said that experimental versions of non-hormonal drugs display benefits in treating the menopausal symptom of hot flashes and even more, presented no risk.
The experimental drugs come from Depomed Inc and Hisamitsu Pharmaceutical Co Inc.
Depomed's shares increased eight percent based on positive reports about their drug, Sefelsa, which previously failed to reach efficacy goals in studies but could still be approved.
Sefelsa was shown to be effective in reducing the severity and frequency of hot flashes in menopausal women after four weeks of treatment, however, the results varied after 12 weeks-according to a FDA staff report.
But Hisamitsu's drug, paroxetine mesylate capsules, were shown to display more consistent results in terms of reducing the occurrence of hot flashes as compared to decreasing the severity of the troubling symptom of menopause.
Both companies are competing to produce the first approved, non-hormonal drug to treat hot flashes.
Hot flashes are described as a "feeling of warmth spreading through your upper body and face" that may be accompanied by a "rapid heartbeat and perspiration mostly on the upper body" followed by a "chilled feeling as the hot flash subsides"-according to the Mayo Clinic.
About 13 million of the estimated 32 million menopausal women who experience hot flashes seek treatment for the symptom in the U.S., according to Depomed as reported by Reuters Health.
The FDA is scheduled to review the drugs during a meeting on Monday based on the staff's findings about the efficacy of the two drugs.
The final decision will be made on Sefelsa by May 31 and June 28 for Hisamitsu's drug.
(SOURCE)
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