Wednesday, June 2, 2004

ADOLOR SUBMITS SECOND PORTION OF ENTEREG NDA

Adolor Corp. submitted the second reviewable unit of its New Drug Application for the investigational pharma brand drug Entereg (alvimopan), which is designed to manage postoperative ileus, a gastrointestinal side effect of many types of surgery.

Adolor is collaborating with GlaxoSmithKline Plc to develop and commercialize the Entereg pharmaceutical branding.

Under the Continuous Marketing Application Pilot 1 Program, Adolor and the FDA agreed that Adolor could submit two predefined portions of the NDA--known as reviewable units--prior to submission of the complete NDA. Adolor submitted the first reviewable unit for Entereg in May.

"Our target remains to complete submission of the entire NDA in the first half of 2004," said Bruce Peacock, Adolor's president and chief executive officer.

The FDA designated Entereg as a fast track product in February. Currently, there are no pharma brands approved for the management of postoperative ileus.

Adolor is also developing Entereg for the treatment of bowel dysfunction in patients using opioid analgesic products as well as for the treatment of chronic constipation in patients not using opioids.