FDA Declines New Indication for Methylnaltrexone

Emma Hitt, PhD

July 31, 2012

July 31, 2012 — The US Food and Drug Administration (FDA) has declined approval of methylnaltrexone bromide (Relistor, Salix Pharmaceuticals, Ltd, and Progenics Pharmaceuticals) for treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.

The FDA issued a complete response letter on Friday of last week regarding a supplemental new drug application for this indication, stating that more data are needed to support the proposed new indication.

Currently, methylnaltrexone bromide in the United States is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, but only when response to laxative therapy has not been sufficient.

The agent was approved in the United States in 2008 and is currently approved for use in 58 countries.

According to the manufacturers' written release, the companies intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to gain a better understanding of the contents of the complete response letter.

The safety of this agent has not been evaluated past 4 months of use. The most common adverse reactions are abdominal pain, flatulence, nausea, dizziness, diarrhea, and hyperhidrosis. Rare cases of gastrointestinal perforation have been reported.

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