Valeant Pharmaceuticals International Inc. has received U.S. Food and Drug Administration approval for Relistor tablets to treat opioid-induced constipation for patients with noncancer pain.

An injectable form of Relistor, which was developed by Progenics Pharmaceuticals Inc., was approved in 2008. In 2011, Progenics licensed Relistor rights in most markets to Salix Pharmaceuticals Ltd., which was sold to Valeant in 2015 for $11.1 billion.

Progenics shares rose 36% to $6.74 in after-hours trading. Valeant was up 4% to $24.50.

Valeant expects to begin U.S. sales of Relistor tablets in the third quarter.

Progenics previously said FDA approval would trigger a $50 million milestone payment. Relistor was the first commercial product for Tarrytown, N.Y.-based Progenics. In the first quarter, Relistor royalty income of $2.2 million provided the bulk of Progenics' $2.5 million of revenue.

In July, Guggenheim Securities said Progenics management believed oral Relistor could be a $1 billion-plus opportunity for Valeant.

In April, the FDA extended its evaluation of Relistor tablets by three months to allow a full review of Valeant's responses to the agency's requests for information.

Also on Tuesday, Valeant said an FDA advisory committee voted unanimously to recommend approval for its psoriasis treatment brodalumab.

In 2015, Valeant was hurt by a political backlash over drug prices and concerns about the company's ties to mail-order pharmacy Philidor Rx Services LLC. The company reduced its earnings guidance in June, citing issues including sales-force turnover that slowed sales growth for irritable-bowel drug Xifaxan.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

July 19, 2016 21:25 ET (01:25 GMT)

Copyright (c) 2016 Dow Jones & Company, Inc.
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