Salix Pharmaceuticals, Ltd. (SLXP: Quote) and Progenics Pharmaceuticals, Inc. (PGNX: Quote) said Friday that they have received a complete response letter from the U.S. Food and Drug Administration following its review of a supplemental new drug application for RELISTOR injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.
The complete response letter requests additional clinical data.
Salix and Progenics said they plan to request an end-of-review meeting with the Division of Gastroenterology and Inborn Errors Products to better understand the contents of the complete response letter.
RELISTOR subcutaneous injection has been FDA approved since 2008 to treat constipation in patients with advanced illness and receiving palliative care, when response to laxative therapy has not been sufficient.
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by RTT Staff Writer
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