The Food and Drug Administration Tuesday night approved Adolor Corp. (ADLR)’s Entereg drug designed to help patients regain gastrointestinal function earlier following bowel resection surgery. The condition the drug was developed to treat, known as postoperative ileus or POI, affects almost all patients undergoing such surgery, and can cause significant discomfort and prolonged hospital stays for patients.
Adolor developed the drug in a partnership with GlaxoSmithKline (GSK), the London-based pharmaceutical giant that has a U.S. headquarters in Philadelphia. It is the first product approval for Adolor.
“The approval of Entereg in POI represents a major milestone for Adolor, and is the culmination of a substantial collaborative effort among Adolor, GlaxoSmithKline, and our clinical investigators,” said Michael R. Dougherty, Adolor’s president and chief executive officer of Adolor Corporation. “Entereg is the first and only product that has demonstrated the ability to address this serious condition, which has negative consequences for patients, and imposes considerable expense on the health-care system.”
Adolor and GlaxoSmithKline submitted data from five clinical studies involving more than 2,500 patients in support of the drug’s approval. The FDA twice issued approvable letters for Entereg, once in 2005 and once in 2006, each time asking for additional clinical trial data before approving the product. In February, the agency delayed its final decision for an additional three months so all the data could be reviewed.
Entereg is approved for hospital use only and will be administered before and after surgery. Adolor and GlaxoSmithKline plan a study in patients undergoing radical cystectomy, another population in which POI is a significant burden, as part of a postmarketing commitment. The two companies signed a co-development and co-marketing plan for Entereg. Adolor received $50 million upfront and the potential to get up to another $220 million if all clinical development and regulatory milestones are met.
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