FDA approves expanded use of constipation drug

By Reuters Staff

(Reuters) - Salix Pharmaceuticals Ltd said the U.S. Food and Drug Administration approved an expanded use of its constipation treatment.

Relistor (methylnaltrexone bromide) subcutaneous injection has now been approved for use in patients on opioids for chronic pain unrelated to cancer, the company said.

In a study in this patient population, a significantly greater portion of patients taking Relistor 12 mg daily reported having three or more spontaneous bowel movements (SBM) per week during the four week double blind period compared to placebo (59% vs 38%).

Following the first dose, 33% of patients in the Relistor once daily treatment group had a SBM within 4 hours and approximately half of patients had a SBM prior to the second dose of the drug.

Relistor subcutaneous injection was well tolerated and the adverse event profile was consistent with other studies of Relistor in an advanced illness population. The most commonly reported side effects included: abdominal pain (21%), diarrhea (6%), nausea (9%) and hyperhidrosis (6%).

Relistor was first approved in 2008 to treat opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

Relistor will compete with Movantik (naloxegol), from Nektar Therapeutics and AstraZeneca, which was approved by the FDA earlier this month for the same patient population.

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