pegeha : FDA to Meet on Adolor, Glaxo's Entereg...
Tuesday January 8, 12:18 pm ET
FDA Experts to Meet Jan. 23 to Review Adolor and GlaxoSmithKline's Troubled Constipation Pill
WASHINGTON (AP) -- The Food and Drug Administration will meet later this month to review the safety and effectiveness of an experimental constipation drug from Adolor Corp.
The Jan. 23 meeting of the agency's gastrointestinal drug panel comes after more than a year of delays and setbacks for Entereg, which Adolor developed with British drug maker GlaxoSmithKline PLC.
The companies have asked FDA to approve the drug to clear intestinal blockage following surgery.
In November 2006 FDA said the drug application was approvable but required more information. Then in April last year the companies suspended testing of the drug after studies showed patients taking it were more likely to develop cancerous lesions and have dangerous heart problems.
Given these issues and FDA's recent conservative stance on safety risks, many analysts doubt Entereg will gain outright approval.
A negative panel review for Entereg would be a major setback for Exton, Pa.-based Adolor, whose only other potential products are two experimental pain medications that are still years away from gaining approval.
Shares of Adolor Corp. rose 8 cents Tuesday to $4.24 in morning trading.