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news.The FDA has requested more information from Adolor Corporation and its development partner GlaxoSmithKline, before it will grant approval for the gastrointestinal drug Entereg.
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The drug is indicated for use in patients following bowel resection surgery, in order to reduce the risk of postoperative ileus, a condition where the intestine becomes incapable of passing its contents.
The partnership believes that the drug will accelerate the time to recovery of gastrointestinal function; however the FDA has requested that the companies give justification that this acceleration is clinically meaningful in reducing the risk of postoperative ileus.
The FDA has also asked that data be presented demonstrating statistically significant results in at least one additional clinical study, in response to this request Adolor has said that it believes this data may be provided from a study that is currently on-going.
“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 CEO of Adolor Corporation.