Adolor: FDA accepts new drug application letter
Biopharmaceutical company Adolor Corp. (Nasdaq: ADLR) announced in conjunction with GlaxoSmithKline plc (NYSE: GSK) that the U.S. Food and Drug Administration has accepted Adolor’s response to the November 2006 new drug application approvable letter for Entereg (alvimopan) for the management of postoperative ileus.
Adolor said in a release that the FDA considers a complete class 2 response with a prescription drug user fee act goal date of Feb.10, 2008.
"We are very pleased that the FDA has accepted for review the complete response for POI," Adolor CEO Michael Dougherty said in a release. "We remain committed to our goal of bringing this novel treatment to patients and surgeons and look forward to working with the FDA throughout the review."
Adolor and GSK also submitted responses to the FDA requesting a release of the clinical holds for all alvimopan investigational new drug applications. The complete responses were received by the FDA on August 13. A release of the clinical holds by the FDA is needed for the two companies to restart any clinical development activities.
Out of the gate, Adolor shares are soaring 19.1%, or $0.68, at $4.24. Over the last 52 weeks, shares have ranged between $3.09 and $25.26.
