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Horizon Pharma Issues Update on Feb. 10-11th FDA Joint Panel Meeting on CV Risk of NSAIDs

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Horizon Pharma, Inc., (NASDAQ: 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."

Posted-In: News FDA


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