Horizon Pharma Updates On FDA Committee Meeting On Cardiovascular Risk Of NSAIDs

(RTTNews) - Horizon Pharma Inc., (HZNP), a commercial stage company that markets two gastroprotective nonsteroidal anti-inflammatory drugs (NSAIDs), Vimovo and Duexis, 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 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 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 Bello, director of clinical research, Illinois Bone and Joint Institute and clinical associate professor of medicine, University of Illinois College of Medicine.

"Recognizing that individuals respond differently to NSAIDs, we make available two prescription strength NSAID options, Vimovo and Duexis, 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 Walbert, chief executive officer, Horizon Pharma.