Progenics Pharmaceuticals, Inc and Wyeth Pharmaceuticals, a division of Wyeth, announced submission of a supplemental New Drug Application (sNDA) to the United States (US) Food and Drug Administration (FDA) and an Extension Application to the European Union (EU) European Medicines Agency (EMEA) for Relistor (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. Relistor was approved last year in single-use vials.

Relistor is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre-filled syringes of Relistor are expected to be available in the US and Europe as early as the first half of 2010. Single-use vials of Relistor will continue to be available.

"The development of Relistor in pre-filled syringes is an important step in our plans to make this medication available in more convenient forms," says Paul J Maddon, founder, chief executive officer and chief science officer, Progenics Pharma. "Pre-filled syringes, containing either 8 mg or 12 mg doses of Relistor, will be ready-to-use, and will ease preparation and administration for patients and caregivers."

Opioid analgesics are frequently prescribed to manage pain in palliative-care patients with advanced illness.

Relistor is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.