NDA resubmitted 1/09; FDA accepts NDA 3/09; PDUFA date 11/9/09 and extended to 2/9/09; JNDA filed in Japan 11/09; Complete response letter received 2/10, and FDA is concerned about a preclinical finding of pancreatic acinar cell tumors in rats; Xenoport will continue to pursue approval in US/Japan (3/10); FDA requesting preclinical data with XenoPort still planning to respond to the Complete response letter in 2H10 (5/10); the pain associated with RLS improved significantly after three months of treatment (6/10); positive phase IIb results in migraine reported 7/10
Brand Horizant (previously known as Solzira) Generic gabapentin encarbil (XP13512)
Company name GlaxoSmithKline, XenoPort Product type Non-speciality
Therapeutic category CNS Key uses Restless Leg Syndrome (RLS)
Other Uses migraine prophylaxis Drug Class Antiepileptic
Dosage From oral, extended-release tablets Expected Approval 2011-Q2
FDA Filing 3/09 Last Update date July 13,2010
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