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 to reach agreement with the FDA on the design of our phase III trial as well as the other clinical and non-clinical studies required for filing an NDA for AP as a treatment for spasticity. We were very encouraged by our previous phase II study of AP that evaluated spasticity in spinal cord injury patients and hope to see similar positive results in MS patients, who we believe are still underserved by current treatments for spasticity,” Ronald W. Barrett, CEO of XenoPort, stated in the press release.
XenoPort plans to initiate the pivotal phase III clinical trial that is the subject of the SPA later this quarter. In line with its end of phase II meeting with the FDA, Xenoport plans to initiate studies as part of the NDA.
For more information visit www.XenoPort.com