Adolor Regains Rights to Entereg(R) (alvimopan) for OBD
Tuesday September 2, 8:30 am ET
EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (Nasdaq: ADLR - News) announced today that GlaxoSmithKline (GSK) has returned to Adolor worldwide rights related to Entereg® (alvimopan) for chronic opioid bowel dysfunction (OBD). GSK is retaining rights to Entereg for postoperative ileus (POI), and the companies will continue to collaborate on the development and commercialization of Entereg for POI in the United States.
Adolor announced in July 2008 that the U. S. Food and Drug Administration (FDA) lifted the clinical hold on the OBD Investigational New Drug Application.
“There is a large, unmet need for treatment options for the many patients who suffer with chronic OBD,” said Michael R. Dougherty, president and chief executive officer of Adolor. “Adolor maintains a portfolio of development candidates that may potentially serve this patient population, including Entereg, our Combination Product Program, and additional earlier stage compounds. We intend now to explore discussions with potential partners regarding this portfolio, and to submit to the FDA for review a protocol for an additional study of Entereg in OBD under a Special Protocol Assessment.”
Mr. Dougherty continued, “We value our relationship with GSK for Entereg in POI a great deal and are pleased with the early progress of our efforts under the E.A.S.E.™ Program. We will continue to work closely with GSK in implementing this Program, and in making this important new product available to bowel resection patients and surgical teams.”
GSK also returned to Adolor rights related to Entereg for irritable bowel syndrome (IBS) and non-opioid induced forms of constipation or bowel dysfunction. There have been no active development programs for these indications.
surf's up......crikey
