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Progenics pre-filled syringes win FDA, EMA approvals

Progenics Pharmaceuticals has received the US Food and Drug Administration (FDA) approval along with the European Medicines Agency (EMA) of the European Union (EU) and Health Canada, the Canadian Regulatory Agency, approvals for single-use, pre-filled syringes of Relistor (methylnaltrexone bromide) subcutaneous injection for use in their respective territories.

The pre-filled syringes provide a simplified dosing option for the treatment of opioid-induced constipation (OIC) in palliative-care patients with advanced illness.

Progenics said that the new pre-filled syringes of Relistor will be available in 8mg and 12mg dosages and single-use vials of Relistor will continue to be available primarily for institutional use.

Progenics founder chief executive and chief science officer Paul Maddon said thatt he pre-filled syringe delivery system provides easier preparation of Relistor for advanced-illness patients with OIC, as well as their caregivers and Progenics is planning for the launch of Relistor in pre-filled syringes in the first half of 2011.