) 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
We note that AstraZeneca had licensed the candidate from
) in Sep 2009.
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the health care sector include
). Both Gilead and Allergan have a Zacks Rank #1 (Strong Buy).
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