Sefelsa gabapentin GR regulatory update

Depomed does not "intend to further invest" in Sefelsa gabapentin after FDA issued a complete response letter for an NDA for the product to treat moderate to severe vasomotor symptoms associated with menopause. According to Depomed, the letter said the agency cannot approve the application in its present form. The company could not be reached for details. After a negative FDA panel in March, Depomed said that it would cease all spending related to Sefelsa "until we believe there is a positive direction" for the product. The FDA panel voted 12-2 that the overall benefit/risk profile of Sefelsa do not support approval for the indication (see BioCentury, March 11). The extended-release tablet formulation of gabapentin uses Depomed's Acuform delivery technology.

Depomed's marketed products include Gralise gabapentin to treat post-herpetic neuralgia (PHN) and Zipsor diclofenac potassium to treat pain. Last November, the company reported that DM-1992, a gastric-retentive, extended-release formulation of levodopa/carbidopa, met the primary endpoint in a Phase II trial for Parkinson's disease (PD) (see BioCentury, Nov. 12, 2012). Gralise is a once-daily formulation of gabapentin using Acuform, and Zipsor is an immediate-release, capsule formulation of diclofenac potassium. Depomed acquired Zipsor from Xanodyne Pharmaceuticals Inc. (Newport, Ky.) last year (see BioCentury, July 2, 2012). ...