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news.Progenics Pharmaceuticals and Salix Pharmaceuticals have received the US Food and Drug Administration (FDA) acceptance for submitting a supplemental new drug application (sNDA) for Relistor (methylnaltrexone bromide) Subcutaneous Injection.
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Relistor Subcutaneous Injection is indicated for the treatment for opioid-induced constipation (OIC) in patients with non-cancer pain.
Salix Research and Development executive vice president and chief development officer Bill Forbes said acceptance of this filing for FDA review is a significant step toward gaining approval for Relistor to treat the underlying cause of OIC experienced by the millions of patients taking opioids for non-cancer pain.
Progenics Medical Affairs senior vice president Robert Israel said this sNDA includes results from 31 studies involving more than 4,000 patients.