September 16, 2008 - GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira™ (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the United States and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.
Solzira is a non-dopaminergic new chemical entity that provides improvement in the symptoms of RLS with the convenience of a once-daily formulation... GlaxoSmithKline's Press Release - XenoPort's Press Release -
