Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) and Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced today that the submission to the European Medicines Agency (EMA) of RELISTOR®(methylnaltrexone bromide) Subcutaneous Injection for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, has been accepted for review. If approved, this will add to the current marketing authorization in the European Union (EU), which allows for the use of RELISTOR® in advanced illness patients.
The marketing of RELISTOR for the treatment of OIC in advanced illness patients was approved in the European Union in 2008, and is currently approved in more than 50 countries. RELISTOR remains the only single agent product approved for the treatment of OIC in the EU. If approved, it is anticipated that RELISTOR will be immediately available to this newly expanded population of patients in the EU using opioids to control chronic pain.
RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.About Opioids, Constipation and RELISTOR® Opioid analgesics are frequently prescribed for patients with chronic pain. Constipation, a common side effect, occurs in patients receiving opioid therapy. RELISTOR® is the first approved medication that specifically targets the underlying cause of OIC in these patients. Opioids relieve pain by specifically interacting with mu-opioid receptors within the brain and spinal cord. However, opioids also interact with mu-opioid receptors found outside the central nervous system, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. RELISTOR® is a peripherally acting mu-opioid receptor antagonist that does not cross the blood-brain barrier and was specifically designed to block mu-opioid receptors in the GI tract, therefore decreasing the constipating effects of opioid pain medications without affecting their ability to relieve pain.