FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

Progenics Pharmaceuticals, Inc.,Sep 30 2010

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA), along with the European Medicines Agency (EMA) of the European Union (E.U.) and Health Canada, the Canadian Regulatory Agency, have each approved single-use, pre-filled syringes of RELISTOR^® (methylnaltrexone bromide) Subcutaneous Injection for use in their respective territories. These pre-filled syringes provide a simplified dosing option for the treatment of opioid-induced constipation (OIC) in palliative-care patients with advanced illness.

“Progenics is planning for the launch of RELISTOR in pre-filled syringes in the first half of 2011.”

"The pre-filled syringe delivery system provides easier preparation of RELISTOR for advanced-illness patients with OIC, as well as their caregivers," said Paul J. Maddon, M.D., Ph.D., Progenics' Founder, Chief Executive and Chief Science Officer. "Progenics is planning for the launch of RELISTOR in pre-filled syringes in the first half of 2011."

RELISTOR is already approved in single-use vials for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The new pre-filled syringes of RELISTOR will be available in 8 mg and 12 mg dosages. Single-use vials of RELISTOR will continue to be available primarily for institutional use.