Valeant Pharmaceuticals International, Inc. VRX and Progenics Pharmaceuticals, Inc. PGNX announced that the former has submitted a new drug application to the FDA for oral Relistor tablets for the treatment of opioid-induced constipation (OIC) in patients suffering from chronic non-cancer pain.
The subcutaneous injectable version of Relistor is already approved in the U.S. for the treatment of OIC in patients receiving palliative care and suffering from advanced illness. It is also approved for the treatment of OIC in patients suffering from chronic non-cancer pain. Earlier this month, the Relistor subcutaneous injection received approval from the European Commission for the treatment of OIC in patients (aged 18 years and above) who did not respond to laxative therapy sufficiently. The drug is now approved in all 28 member states of the EU as well as in Iceland and Norway.
We remind investors that Valeant in-licensed the development and commercialization rights for Relistor from Progenics following the acquisition of Salix Pharmaceuticals by Valeant in Apr 2015. In 2014, net sales of Relistor (as reported by Salix) totaled $20.3 million, down 48.5% year over year. Potential approval of the oral formulation for the drug should increase the eligible patient population thereby boosting the top line.
We note that AstraZeneca’s AZN Movantik tablets are already approved by the FDA as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) therapy for the treatment of OIC in patients suffering from chronic non-cancer pain. Relistor belongs to same PAMORA class as Movantik.
Valeant carries a Zacks Rank #1 (Strong Buy). Another favorably-ranked stock in the health care sector is Anacor Pharmaceuticals, Inc. ANAC carrying a Zacks Rank #2 (Buy).
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