AstraZeneca (AZN - Free Report) announced that data related to its opioid-induced constipation (OIC) candidate, naloxegol (proposed brand name: Movantik), was published in the New England Journal of Medicine (NEJM). The NEJM published data from two pivotal phase III studies – KODIAC-4 and KODIAC-5 – on naloxegol.
The randomized, double-blind, placebo-controlled studies evaluated two doses – 12.5 mg and 25 mg – of naloxegol. The 25 mg dose met the primary endpoint. The data from the studies showed that OIC patients who received naloxegol 25 demonstrated consistent response of increased spontaneous bowel movements (SBMs) through 12 weeks of treatment versus placebo. Additionally, over 12 weeks, the number of SBMs per week increased with naloxegol 25 mg treatment.
Naloxegol is a peripherally acting mu-opioid receptor antagonist (PAMORA). Naloxegol is under review in the U.S. for OIC in patients with chronic non-cancer pain. The FDA is expected to render a final decision on the approval of naloxegol by Sep 16, 2014.
Earlier in the month, the majority of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that cardiovascular outcomes studies are not needed for the PAMORA class of drugs. The panel recommendation is a major positive as additional cardiovascular outcomes studies would have increased the cost of developing naloxegol. This could have also resulted in a delay in the approval process.
The candidate is also under review in the EU and Canada for the same indication.
We note that AstraZeneca had licensed the candidate from Nektar Therapeutics (NKTR - Free Report) in Sep 2009.
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences (GILD - Free Report) and Allergan (AGN - Free Report) . Both Gilead and Allergan have a Zacks Rank #1 (Strong Buy).