All our eyes on the (not so) distant Horizant as XenoPort seeks shelter from storm
This article was originally published in Scrip
Executive Summary
As XenoPort halted development of arbaclofen as a treatment for gastro-oesophageal reflux disease (GORD), the attention of investors and analysts is turning back to the stalled regulatory status of the company’s candidate product in restless legs syndrome, Horizant (gabapentin enacarbil). As the product approaches its new PDUFA date of 6 April, some analysts consider that concerns at the FDA that the compound may cause pancreatic cancer are unfounded. Nevertheless, FDA unpredictability and an understandable lack of urgency in a well-populated RLS market still casts a cloud over the product.