With concerns about risks associated with conventional hormone replacement therapy (HRT) manufactured from the urine of pregnant mares (i.e. Premarin®, Prempro®) Depomed Inc., a specialty pharmaceutical company headquartered in Newark, California, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on July 31, 2012 for Serada™ – an extended time release formulation designed to provide women with prolonged relief of menopausal “hot flashes” with potential for reduced side effects.
Approximately one month later on August 29, 2012, Noven Pharmaceuticals announced that it had submitted a NDA for low-dose mesylate salt of paroxetine (LDMP) to the FDA also seeking approval for the treatment of vasomotor symptoms associated with menopause. LDMP is an investigational oral non-hormonal therapy specifically developed for the treatment of vasomotor symptoms due to menopause.
Hormone replacement therapy manufactured from pregnant mare’s urine is currently the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes
The FDA formally accepted the application for Serada™ on October 15, 2012 and established a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. Similarly, the application for LDMP was also accepted with an assigned PDUFA action date of June 28, 2013. These dates represent the goal date for the completion of the FDA NDA review.
Hormone replacement therapy manufactured from pregnant mare’s urine is currently the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes. In the United States alone there is an estimated 32 million women who experience menopausal hot flashes, of whom 13 million seek medical treatment.
Moreover, vasomotor symptoms – hot flashes and night sweats – are the most common medical complaint of perimenopausal and postmenopausal women affecting upwards of 80% of women experiencing menopause. In fact, there is evidence that sleep disturbances due to moderate to severe hot flashes is the leading driver of women seeking prescription HRT products.
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