FDA requests further data in review of Relistor (Salix) for Opioid-induced Constipation
The FDA have provided a Complete Response Letter (CRL) following its review of a Supplemental New Drug Application (sNDA) for Relistor (methylnaltrexone bromide), from Salix, for the treatment of Opioid-induced Constipation in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the CRL.
Relistor Subcutaneous Injection was approved in the US in 2008 for the treatment of Opioid-induced Constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient, and in 2012 for chronic, non-cancer pain.
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