XenoPort Inc. (XNPT) Reaches Agreement with FDA to Advance Trials of Multiple Sclerosis Treatment
XenoPort Inc. has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a pivotal phase III clinical trial of arbaclofen placarbil (AP) as potential treatment of spasticity in multiple sclerosis (MS) patients. The company has also completed an end of phase II meeting with the FDA regarding the additional studies needed to position the company to submit a New Drug Application (NDA) for AP as a treatment for spasticity, a debilitating condition associated with some common neurological disorders, such as MS, spinal cord injury, stroke and cerebral palsy. “We are pleased…