FDA needs more data on Adolor drug

Biopharmaceutical company Adolor will have to provide more data on its post-bowel surgery recovery treatment to gain Food and Drug Administration approval, the company announced after receiving an "approvable letter" from the FDA. Adolor said it needs to provide "statistically significant results" in at least one more clinical study to show that the drug speeds recovery of the digestive system after surgery. The company says it believes the data can be produced from an existing study. Adolor is collaborating with GlaxoSmithKline on the development and marketing of Entereg.

- read this story from Medical News Today for more

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