Horizon Pharma, Inc.,
HZNP, a commercial stage, specialty pharmaceutical company
that markets two gastroprotective nonsteroidal anti-inflammatory
drugs (NSAIDs), VIMOVO(R) (naproxen/esomeprazole magnesium) and
DUEXIS(R) (ibuprofen and famotidine), announced that the FDA joint
Arthritis Advisory Committee and Drug Safety and Risk Management
Advisory Committee was split on whether the data show adequate
differences in cardiovascular risk among NSAIDs to support labeling
change for NSAIDs due to cardiovascular (CV) risk. The committee
found that there was not enough data at this time to differentiate
among the NSAIDs. During the discussion, the committee did recognize
the risk of gastrointestinal (GI) events when taking NSAIDs. The FDA
will take the committee's discussion into consideration and will make
the final determination in this matter.
"Osteoarthritis and rheumatoid arthritis are often highly
debilitating and the source of significant distress for millions of
people, yet the potential cardiovascular risks associated with NSAIDs
can be a treatment barrier for many patients," said Alfonso E. Bello,
M.D., director of clinical research, Illinois Bone and Joint
Institute and clinical associate professor of medicine, University of
Illinois College of Medicine. "The committee discussion reinforces
the potential CV risk of NSAIDs and the need for physicians to
discuss this with their patients. While the committee vote was split,
the committee did acknowledge the potential to differentiate naproxen
from the other NSAIDs. While we still need to determine how best to
manage the CV risk, we can manage the more common risk of GI events
through gastroprotection."
"Recognizing that individuals respond differently to NSAIDs, we make
available two prescription strength NSAID options, VIMOVO(R) and
DUEXIS(R), both of which have demonstrated a significant reduction in
gastrointestinal ulcers, allowing prescribers the ability to treat a
broad range of arthritis patients," said Timothy P. Walbert,
chairman, president and chief executive officer, Horizon Pharma. "We
are committed to bringing safe and effective treatment options to
patients."
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