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Approvable Letter Issued for Alvimopan But Additional Proof of Efficacy Needed
Before the application may be approved, it will be necessary to provide additional proof of efficacy to the FDA to support the use of Entereg following bowel resection surgery. The FDA indicated that this may be achieved by demonstrating statistically significant results in at least one additional clinical study, and that this could potentially be addressed with positive results from Adolor's ongoing Study 14CL314. The FDA also indicated that the Company must provide justification that the median reduction in time to gastrointestinal recovery seen in bowel resection patients treated with Entereg is clinically meaningful.
"We intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps for the NDA," said Bruce Peacock, president and chief executive officer of Adolor Corporation.
About Study 14CL314
Adolor is currently conducting Study 314 in POI. Study 314 has been designed to enroll 660 bowel resection patients, randomized into two arms to receive either placebo or 12 mg of Entereg twice daily. The protocol for Study 314 provides that the initial dose of Entereg should be administered 30 to 90 minutes prior to surgery, as compared to Adolor's previous Phase 3 studies where the first dose was required to be administered (at least) 120 minutes prior to surgery. The primary endpoint of Study 314 is time to recovery of GI function ("GI2"), a composite measure of the time to recovery of both upper and lower GI function, as defined by time to tolerability of solid foods, and time to first bowel movement, whichever occurred last.
About Entereg (alvimopan)
Entereg(R) (alvimopan) is an investigational peripherally-acting mu-opioid receptor (PAM-OR) antagonist designed to inhibit the negative effects of opioids, like morphine, on the gastrointestinal system without interfering with the analgesic effects in the central nervous system.
Source: Adolor Corporation