FDA approves Progenics and Valeant's oral Relistor for OIC

20 July 2016

The Food and Drug Administration has approved Relistor (methylnaltrexone bromide) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

The drug was developed by the USA’s Progenics Pharmaceuticals (Nasdaq: PGNX) and will be marketed by Canada-based Valeant Pharmaceuticals International (TSX: VRX). Previously, Relistor subcutaneous injection was approved in 2008 for the treatment of OIC in adults.

Valeant expects to commence sales of Relistor tablets in the USA in the third quarter of 2016. Progenics shares rose 36% to $6.74 in after-hours trading. Valeant was up 4% to $24.50. Relistor Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.

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