Valeant : FDA Oks RELISTOR Tablets To Treat Opioid-induced Constipation

(RTTNews) - Valeant Pharmaceuticals International Inc. (VRX, VRX.TO) and Progenics Pharmaceuticals Inc. (PGNX) announced that the U.S. Food and Drug Administration has approved RELISTOR (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation or OIC. Valeant expects to commence sales of RELISTOR Tablets in the U.S. in the third quarter of 2016.

PGNX closed Tuesday's regular trading at $4.94, down $0.46 or 8.52 percent. However, in the after-hours trade, the stock gained $1.81 or 36.64%.

VRX closed Tuesday's regular trading $23.54, up $0.04 or 0.17%. In the after-hours trade, the stock further gained $1.01 or 4.29%.

"Opioid-induced constipation represents a long-lasting and potentially debilitating side effect of opioid therapy for millions of patients suffering from chronic pain," commented Joseph C. Papa, Chief Executive Officer of Valeant.

Today, the FDA approved RELISTOR Tablets (450 mg once daily) for the treatment of OIC in adults with chronic non-cancer pain. Previously, RELISTOR Subcutaneous Injection (12 mg and 8 mg) was approved in 2008 for the treatment of OIC in adults with advanced illness who are receiving palliative care and in 2014 for the treatment of OIC in adults with chronic non-cancer pain.

RELISTOR (methylnaltrexone bromide) Tablets is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.