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FDA Rejects Methylnaltrexone Bromide for Opioid-Induced Constipation

Salix and Progenics intend to request a meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL.

Relistor is a peripherally acting mu–opioid receptor antagonist designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. Because the drug does not cross the blood–brain barrier, it relieves the effects of the constipation while retaining the analgesic effect of the opioid.

Relistor Subcutaneous Injection has been approved since 2008 to treat constipation in patients with advanced illness and in those receiving palliative care when the response to laxative therapy has not been sufficient.

For more information, visit the Salix Web site.

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