Depomed, Inc.'s Drug Serada Ready for FDA Approval
Published: Feb 21, 2013
On March 4, 2013, the FDA will hold an advisory committee meeting for Depomed's (DEPO) drug Serada. The committee will evaluate whether Serada is a safe and efficacious treatment for menopausal hot flashes. In this article we review scientific and clinical aspects of Serada and conclude it is likely to receive a favorable vote during its upcoming advisory committee meeting. Depomed is a specialty pharmaceutical company focused on enhancing existing drug products. Depomed's main technology, Acuform, optimizes drug delivery. Specifically, Acuform retains tablets in the stomach for up to nine hours after ingestion. During this time, the tablet's active ingredient releases at a relatively slow rate. This gradual release permits less frequent dosing and alleviates side effects. Depomed already has two FDA-approved drug products based on Acuform. The company's current lead product candidate, Serada, uses Acuform to deliver gabapentin, a drug previously approved by the FDA for the treatment of epilepsy and neuropathic pain. Serada has been developed to treat menopausal hot flashes, which are characterized by sudden, temporary onset of body warmth, flushing, and sweating. Depending on the intensity of a given episode, hot flashes can also involve headache, fatigue, dizziness, and heart palpitations. Overall, hot flashes negatively impact mood, sleep, and quality of life.