FDA to Expedite Review of Constipation Drug Lubiprostone

September 27, 2012

(Reuters) Sep 26 - Pharmaceutical company Sucampo said U.S. health regulators will review the company's application for wider use of its constipation drug Amitiza (lubiprostone) sooner than usual.

The company is trying to gain U.S. approval for the drug to treat constipation caused by opioids in patients with chronic, non-cancer pain.

The expedited review granted by the U.S. Food and Drug Administration means that Amitiza's application to gain approval for this new use will now be reviewed in six months, instead of the standard ten months.

Sucampo has a partnership with the Japan-based company Takeda on Amitiza.

The drug is approved in the United States to treat chronic constipation in adults, and for irritable bowel syndrome accompanied by constipation in adult women.

The companies said they expect the FDA to deliver a decision by late January 2013.

Opioids are very effective at managing pain, but constipation is a very common side-effect. The FDA grants priority review for treatments that aim to cure serious diseases and fill unmet medical needs.