FDA Extends Review for Drug to Treat Post-Opioid Constipation
FDA Extends Review for Drug to Treat Post-Opioid Constipation
(Reuters) Apr 25 - Salix Pharmaceuticals Ltd and Progenics Pharmaceuticals said U.S. health regulators had extended by three months the review date for an additional indication of their constipation drug.
The U.S. Food and Drug Administration was to review Relistor (methylnaltrexone injection) as a treatment for opioid-induced constipation (OIC) in patients with chronic, non-cancer pain on April 27.
Relistor is currently approved for use in OIC patients receiving palliative care in whom laxatives are not sufficient. Use of Relistor beyond 4 months has not been studied, the companies said in a statement.
The FDA has notified Salix that it requires additional time for a full review but did not seek any additional studies, according to the statement.
(Reuters) Apr 25 - Salix Pharmaceuticals Ltd and Progenics Pharmaceuticals said U.S. health regulators had extended by three months the review date for an additional indication of their constipation drug.
The U.S. Food and Drug Administration was to review Relistor (methylnaltrexone injection) as a treatment for opioid-induced constipation (OIC) in patients with chronic, non-cancer pain on April 27.
Relistor is currently approved for use in OIC patients receiving palliative care in whom laxatives are not sufficient. Use of Relistor beyond 4 months has not been studied, the companies said in a statement.
The FDA has notified Salix that it requires additional time for a full review but did not seek any additional studies, according to the statement.
