Adolor tanks on negative trial results of bowel disorder drug
Adolor Corp. (Nasdaq: ADLR) reported late Monday disappointing clinical trial results of Entereg, its experimental treatment for the management of postoperative ileus – a bowel disorder commonly experienced by patients after surgery.
Exton, Pa.-based Adolor is developing the drug with pharmaceutical giant GlaxoSmithKline (NYSE: GSK). The companies found that Entereg, also known as alvimopan, resulted in side effects such abdominal pain, diarrhea, skin cancers, fractures, and heart problems in a phase III clinical trial.
Adolor’s stock lost more than half of its value in after-hours trading Monday on the results. Shares had sunk by $5.22, or 59.8%, to $3.49 on heavy volume of 2.9 million shares after the market closed.
Last December, Adolor announced plans to let go its sales force of 35 people and eliminate 17 other positions because of delays in getting approval for Entereg, its lead new drug candidate.
The U.S. Food and Drug Administration issued approvable letters for Entereg in 2005 and again in November of 2006, but final approval was on hold pending the submission of additional clinical trial safety data by Adolor and GlaxoSmithKline.
Adolor said that additional data on the drug is being collected and that further analyses will be undertaken. In the meantime, GlaxoSmithKline has withdrawn a protocol for an additional phase III safety and efficacy study on Entereg that had been submitted to federal regulators. It also has stopped another study in what it calls “a precautionary measure.”
Adolor also has suspended enrollment in a study of rotator cuff surgery patients.
By Mary Ann Azevedo
