Valeant/Progenics Relistor Ok'd; FDA Panel Backs Brodalumab
Zacks Investment Research | Jul 19, 2016 09:34PM ET
Valeant Pharmaceuticals International, Inc. (NYSE:VRX) has received positive news on the regulatory front. Its constipation drug, Relistor, received regulatory approval in the U.S., while the FDA Advisory Committee gave a recommendation favoring the approval of its psoriasis treatment, brodalumab.
Relistor’s Approval
The FDA has approved Valeant and Progenics Pharmaceuticals, Inc.’s (NASDAQ:PGNX) Relistor tablets (450 mg once daily) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Valeant expects to begin sales in the third quarter of 2016.
We note that a subcutaneous injectable version of Relistor (12 mg and 8 mg) is already approved in the U.S. for the treatment of OIC in adults with chronic non-cancer pain and for the treatment of OIC in adults with advanced illness who are receiving palliative care.
We remind investors that Valeant had in-licensed development and commercialization rights for Relistor from Progenics following the acquisition of Salix Pharmaceuticals in Apr 2015.
Approval of the oral formulation for the drug should expand the eligible patient population, thereby boosting the company’s top line. We expect investor focus to remain on the commercialization of Relistor for the recently approved indication.
Drugs that are currently approved for the treatment of OIC in patients with chronic pain include Movantik and Amitiza.
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