SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. (Nasdaq:XNPT) announced today that it plans to move arbaclofen placarbil (AP), also known as XP19986, into Phase 3 development as a potential treatment of spasticity in multiple sclerosis (MS) patients. Following discussions with the U.S. Food and Drug Administration (FDA), XenoPort intends to conduct a single placebo-controlled Phase 3 efficacy clinical trial and an open-label, long-term, safety study of AP in patients with MS. Favorable results from these studies could lead to the filing of a new drug application (NDA) with the FDA under Section 505(b)(2) seeking approval of AP for the treatment of spasticity.
