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AstraZenecaAnnouncement

06/09/2014 02:19

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RNS Number : 5392J
AstraZeneca PLC
13 June 2014 
 
US FDA ADVISORY COMMITTEE RECOMMENDS NO CARDIOVASCULAR OUTCOMES TRIAL FOR
PERIPHERALLY-ACTING MU-OPIOID RECEPTOR ANTAGONIST (PAMORA) CLASS INCLUDING
MOVANTIK 
 
AstraZeneca announced today that the majority of US Food and Drug
Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee
(AADPAC) members voted that the FDA should not require cardiovascular outcomes
trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA)
class of drugs, which includes MOVANTIKTM (naloxegol oxalate), an
investigational treatment for opioid-induced constipation (OIC) for patients
with chronic non-cancer pain. Following a clarification of the vote, the
majority of the Committee suggested continued post-approval data collection
for cardiovascular safety. 
 
The FDA convened a meeting of the AADPAC to review the class of peripherally
acting opioid receptor antagonists on 11-12 June 2014. The meeting assessed
the necessity, timing, design and size of cardiovascular outcomes trials to
support approval of products in the class, for the proposed indication of OIC
in patients taking opioids for chronic non-cancer pain. The FDA is not bound
by the Advisory Committee's recommendation, but takes its advice into
consideration when reviewing applications for investigational medicines. The
Prescription Drug User Fee Act (PDUFA) date set by the FDA for MOVANTIK is 16
September 2014. 
 
Briggs Morrison, Executive Vice President, Global Medicines Development and
Chief Medical Officer said: "We are pleased that the Committee  did not find
it necessary to require a cardiovascular outcomes trial for the PAMORA class.
We look forward to the outcome of the FDA's review of the New Drug Application
for MOVANTIK and the potential to provide patients with chronic non-cancer
pain affected by OIC with an additional treatment option." 
 
Opioids play an important role in chronic pain relief by binding mu-receptors
in the brain, but they also bind mu-receptors in the bowel. That is why
patients taking opioids for chronic pain can develop OIC. In fact, the
incidence of OIC can be as high as 81% in patients taking opioids. There is a
significant unmet need for safe, effective treatment options for patients with
OIC. An estimated 235 million prescriptions for opioids are written in the US
each year, of which 20% are for chronic pain. For patients taking prescription
opioids for chronic pain, constipation is one of the most common side effects
and one not adequately relieved by laxatives. 
 
If approved, MOVANTIK has the potential to be the first once-daily, oral
PAMORA for the treatment of OIC for patients with chronic non-cancer pain.
MOVANTIK is also under regulatory review with health agencies in the European
Union and Canada. 
 
On 4 June 2014 the New England Journal of Medicine published data online from
two pivotal Phase III studies of MOVANTIK, KODIAC-4 and KODIAC-5. Both studies
met their primary endpoint, showing an improvement in treatment effect versus
placebo: more OIC non-cancer pain patients treated with MOVANTIK at a 25 mg
dose had a consistent response of increased spontaneous bowel movements
through 12 weeks of treatment compared to placebo. 
 
About MOVANTIKTM (naloxegol oxalate) 
 
MOVANTIK is an investigational peripherally-acting mu-opioid receptor
antagonist (PAMORA) specifically designed for the treatment of opioid-induced
constipation (OIC) in patients with chronic non-cancer pain. In the Phase III
clinical studies, MOVANTIK was administered as a once-daily tablet and is
designed to block the binding of opioids to the opioid receptors in the
gastrointestinal (GI) tract without impacting the opioid receptors in the
brain. 
 
MOVANTIK is part of the exclusive worldwide licence agreement announced on 21
September 2009, between AstraZeneca and Nektar Therapeutics. MOVANTIK was
developed using Nektar's oral small molecule polymer conjugate technology. 
 
About Opioid-Induced Constipation (OIC) 
 
Opioids play an important role in chronic pain relief by binding mu-receptors
in the brain. But they also bind mu-receptors in the bowel. That is why
patients taking opioids for chronic pain can develop opioid-induced
constipation (OIC). In fact, the incidence of OIC varies and has been reported
as high as 81% in patients taking opioids. 
 
About AstraZeneca 
 
AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com 
 
CONTACTS 
 
Media Enquiries 
 
Esra Erkal-Paler    +44 20 7604 8030 (UK/Global)
Vanessa Rhodes   +44 20 7604 8037 (UK/Global)
Ayesha Bharmal    +44 20 7604 8034 (UK/Global)
Michele Meixell      +1 302 885 2677 (US)
Jacob Lund            +46 8 553 260 20 (Sweden) 
 
Investor Enquiries 
 
Karl Hård              +44 20 7604 8123 mob: +44 7789 654364 
 
Colleen Proctor    +44 207 604 8128    mob: +1 302 357 4882 
 
Anthony Brown    +44 20 7604 8067    mob: +44 7585 404943 
 
Jens Lindberg      +44 20 7604 8414    mob: +44 7557 319729 
 
13 June 2014 
 
-ENDS- 
 
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