Adolor to start phase 2 study of co-administering Hydrocodone/APAP and alvimopan

By Ted A. Knutson

Washington, March 10 - Adolor Corp. said it expects to start a phase 2 dose ranging study with a co-administered product of Hydrocodone/APAP and alvimopan in the second quarter.

The study will involve 300 patients undergoing ambulatory shoulder surgery for rotator cuff repair to evaluate analgesic efficacy and gastrointestinal side effects.

Adolor also announced that it anticipates filing in the third quarter of 2006 an Investigational New Drug application for a co-formulated product and beginning in the fourth quarter of 2006 a pharmacokinetic study comparing the co-formulated product with co-administered products.

The firm also reported that it expects that phase 3 pivotal studies will be required for the acute combination product.

The developments, which the company reported in an 8-K filing with the Securities and Exchange Commission Friday, were also disclosed by the firm at Lehman Brothers' Ninth Annual Global Healthcare Conference in Miami Beach, Fla., Thursday.

Adolor is an Exton, Pa.-based biotechnology company.

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