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news.Biopharmaceutical firm Progenics Pharmaceuticals has filed supplemental new drug application (sNDA) for Relistor (methylnaltrexone bromide) subcutaneous injection with the US Food and Drug Administration (FDA).
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Relistor is indicated as a treatment for opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
The drug is currently approved in the US, Australia, European Union, Canada and other countries as a treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
Progenics CEO Mark Baker said this regulatory submission is an important milestone for Progenics as they work with their development and commercialization partner, Salix Pharmaceuticals, to make Relistor available to a broader population of patients.