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Shire's constipation therapy recommended for approval by US FDA panel

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Shire's constipation therapy recommended for approval by US FDA panel

Shire PLC said a U.S. Food and Drug Administration panel recommended the approval of prucalopride to treat chronic idiopathic constipation.

The disease, which affects about 35 million adults in the U.S., is characterized by difficulty with the passage of stools and symptoms including abdominal pain or bloating.

The U.S. FDA's Gastrointestinal Drugs Advisory Committee voted unanimously to support the drug's approval, indicating that the drug's benefit outweighs its risk.

Prucalopride is a selective serotonin type 4, or 5-HT4, receptor agonist that increases bowel motility or the movement in the intestines to push its content further.

The Dublin-based company said other 5-HT4 receptor agonists belonging to prucalopride's class have been associated with adverse cardiovascular events in the past.

Drugs belonging to same class such as Johnson & Johnson's Propulsid, or cisapride, and Novartis AG's Zelnorm, or tegaserod maleate, were pulled from the market due to cardiovascular risks.

The FDA, which has set a review deadline of Dec. 21 for prucalopride, takes into account the panel's opinion in making the final decision.

Shire said the application includes data from five main phase 3 and one phase 4 trial as well as from a pharmacoepidemiology safety study, which explore adverse drug reactions in specific populations.

Prucalopride is already marketed as Resolor in the EU to treat chronic constipation in adults in whom laxatives, commonly used constipation treatments, fail to provide adequate relief.