US Market News 9-05-06

Adolor shares down 46% on drug's study results
Tuesday September 5, 12:06 pm ET

Adolor and GlaxoSmithKline reported mixed results from the latest clinical tests for Entereg, an experimental treatment for bowel disorders suffered by patients taking opioids for pain relief.
The Food and Drug Administration issued an approvable letter for Entereg last year, but the agency requested additional clinical-trial data before it would issue final approval.

On Tuesday, the companies said Entereg achieved statistical significance in its primary goal of helping patients achieve three or more spontaneous bowel movements in one of two studies.

Adolor was trading down 46 percent at $13.42 Tuesday. GlaxoSmithKline was down 1 percent at $56.21.

Entereg was develop by Adolor, which in 2002 entered into a co-development and promotion agreement with GlaxoSmithKline for it.

Published September 5, 2006 by the Philadelphia Business Journal

So, What happened here? What does this drug do? While one of two identical phase III studies achieved its goal, the other did not. A phase IIb study of the drug also failed to reach its goal. However, both of the trials that missed their main targets did achieve a secondary objective of altering the average weekly frequency of spontaneous bowel movements. Entereg was developed to relieve non cancerous pain in the bowel caused by opioid abuse. Of course, the most commonly abused opioids are heroin, morphine and oxycodone. Constipation has long been recognized as an effect of opioids. Opioid receptors (G proteins) exist in high density within the gastrointestinal tract, and the constipating effects are mediated through the GI nerve system. Also, the stomach action of pushing food through the small intestine is decreased as well as stomach acid production. Peristaltic waves that move intestinal contents are also diminished (think of how a caterpillar crawls in waves, same thing). So its clear why they need a drug like Entereg, but pulling it out of phase III most likely means it did not meet efficacy in a large number of patients.