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VIMOVOTM
Label
VIMOVO™ (naproxen and esomeprazole magnesium)
delayed release tablets is a fixed-dose combination of
enteric-coated naproxen, a pain-relieving non-steroidal
anti-inflammatory drug (NSAID) and immediate release esomeprazole, a
proton pump inhibitor (PPI), indicated for the relief of signs and
symptoms of osteoarthritis (OA), rheumatoid arthritis (RA), and
ankylosing spondylitis (AS) and to decrease the risk of developing
gastric ulcers in patients at risk of developing NSAID associated
gastric ulcers.
Twenty-seven million Americans are affected by osteoarthritis which
is the most common form of arthritis. While many patients with
osteoarthritis treat their symptoms with NSAIDS, 50% of chronic
NSAID users are at risk of developing gastrointestinal ulcers.
VIMOVO is an important new treatment option that aligns with the
current recommendations of the American College of Gastroenterology
and the American College of Rheumatology’s Ad Hoc Group on the use
of selective and non-selective NSAIDs for patients at risk to
develop gastric ulcers but who need to take an NSAID.
The FDA approval of VIMOVO is supported by data from a comprehensive
clinical trials program, including results from the 6 month studies
PN400-301 and PN400-302 studies. In the PN400-301 and 302 studies,
the primary end point was the cumulative incidence of gastric ulcers
through six months. In each of the trials, patients received either
VIMOVO or enteric-coated naproxen (500 mg), twice daily, over a
six-month treatment period. Endoscopies were performed at baseline
and at one, three, and six months. Data from study PN400-301 showed
a 4.1% incidence of gastric ulcers in patients taking VIMOVO,
compared to 23.1% among patients taking enteric-coated naproxen
(p<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers
among patients taking VIMOVO, compared to 24.3% with enteric-coated
naproxen (p<0.001).
Development Program - VIMOVO™
In April 2006, the company completed a Special
Protocol Assessment (SPA) and reached agreement with the U.S. Food
and Drug Administration (FDA) on the design of its pivotal trials
for the VIMOVO product candidate.
In August 2006, POZEN announced that it signed an exclusive global
collaboration agreement with AstraZeneca for the co-development and
commercialization of a proprietary fixed dose combination of the
PPI, esomeprazole magnesium, with the NSAID, naproxen, in a single
tablet.
The Phase III pivotal trials for VIMOVO™ (naproxen/esomeprazole)
were initiated in September 2007 and the New Drug Application (NDA)
was submitted in June 2009.
On August 31, 2009, the FDA informed POZEN that it had accepted the
NDA for VIMOVO, submitted on June 30, 2009. AstraZeneca (AZ)
submitted a Marketing Authorization Application (MAA) to the
European Union via the Decentralized Procedure for VIMOVO™ on
October 16, 2009.
On April 30, 2010, the FDA notified POZEN that it had approved
VIMOVO TM (naproxen and esomeprazole magnesium) delayed-release
tablets for the relief of signs and symptoms of osteoarthritis,
rheumatoid arthritis, and ankylosing spondylitis, and to decrease
the risk of developing gastric ulcers in patients at risk of
developing NSAID-associated gastric ulcers.
For complete Safety and Prescribing Information, including Boxed
Warnings, please visit
www.vimovo.com.
About Osteoarthritis:
Osteoarthritis (OA) is a degenerative joint disease caused by the
breakdown and eventual loss of the cartilage of one or more joints.
Osteoarthritis is the most common form of arthritis and the most
common cause of chronic pain, affecting nearly 151 million
individuals worldwide, and impacting approximately 18% of women and
9.6% of men aged 60 and above. A combination of factors can
contribute to osteoarthritis, including being overweight, aging,
joint injury or stress, heredity and muscle weakness. Osteoarthritis
commonly affects the hands, feet, spine or large weight-bearing
joints, such as the hips and knees.
About Rheumatoid Arthritis:
Rheumatoid arthritis (RA) is a chronic disease, mainly characterized
by inflammation of the lining, or synovium, of the joints. It can
lead to long-term joint damage, resulting in chronic pain, loss of
function and disability. RA affects approximately 1.3 million
Americans.
About Ankylosing Spondylitis:
Ankylosing spondylitis (AS) is a chronic inflammatory disease that
primarily causes pain and inflammation of the joints between the
vertebrae of the spine and the joints between the spine and pelvis
(sacroiliac joints). Ankylosing spondylitis may also cause
inflammation and pain in other parts of the body as well.
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