The Reproductive Health Drugs Advisory Committee (RHDAC) of the US Food and Drug Administration (FDA) has voted 2-12 against approval for Depomed's Sefelsa, an investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to menopause. Sefelsa is the proposed trade name for the medication and was formerly referred to as Serada.
"Depomed today is a product-focused, growth-oriented specialty pharmaceutical company with a growing franchise of treatments for pain and potentially other CNS indications. With revenues from two marketed products, Gralise and Zipsor, significant royalty income from our partnered products and technology, a strong balance sheet and potential to turn cash flow positive in the second half of this year, we believe that 2013 has the potential to be a landmark year in our company's history," said Jim Schoeneck, president and CEO of Depomed. "We recognise and appreciate the concerns that were raised by the members of the Advisory Committee. Based on today's meeting we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high. Until we believe there is a positive direction for Sefelsa, we will cease all spending relating to the product candidate."
Data presented at Advisory Committee Meeting included results from the phase III clinical programme, which enrolled 1706 patients in three studies.
The FDA will consider the Advisory Committee recommendation in its review of the New Drug Application (NDA) for Sefelsa that Depomed submitted on July 31, 2012, though the FDA is not bound to follow it. The Prescription Drug User Fee Act (PDUFA) date for Sefelsa is May 31, 2013. The PDUFA date is the goal date for the FDA to complete its review of the NDA.
Vasomotor symptoms include hot flashes and night sweats. A hot flash is a sudden flushing and sensation of heat caused by dilation of skin capillaries. Currently, the leading prescription drug product for the treatment of hot flashes associated with menopause is hormone replacement therapy (HRT). HRT involves the administration of the hormone estrogen, either alone or in combination with the hormone progestin.
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products.