AstraZeneca (AZN) announced that the FDA has cleared Movantik for use in adults with chronic non-cancer pain suffering from opioid-induced constipation (OIC), a common side effect of opioid therapy for chronic pain. The drug is expected to be available in the U.S. from the first half of 2015. Movantik is a peripherally acting mu-opioid receptor antagonist (PAMORA).
The approval follows the Jun 2014 Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) review where the majority of the members had voted that cardiovascular outcomes studies are not needed for the PAMORA class of drugs.
Currently, Movantik is a schedule II controlled substance. AstraZeneca is working towards the descheduling of the drug and has submitted a petition for the same to the U.S. Drug Enforcement Administration in Mar 2012.
We note that AstraZeneca has a worldwide license agreement with Nektar Therapeutics (NKTR) for Movantik.
Our Take
The FDA approval of Movantik marks the first approval of a once-daily oral PAMORA class of drug specifically indicated for the treatment of OIC in patients with chronic, non-cancer pain. This provides patients with an alternative treatment option.
We note that Progenics Pharmaceuticals, Inc. (PGNX) and Salix Pharmaceuticals, Inc. (SLXP) are also looking to expand Relistor’s label to include the OIC indication in patients with chronic non-cancer pain. Relistor is also a PAMORA. The FDA is expected to render a final decision on Relistor for the above mentioned indication by Sep 29.
AstraZeneca carries a Zacks Rank #3 (Hold). Gilead Sciences (GILD) is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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