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NicOx’s osteoarthritis drug naproxcinod has been rejected by a panel of US regulators, after concerns were raised about its allegedly superior safety profile.
Voting 16-1 against the product, the Food and Drug Administration’s (FDA) Arthritis and Drug Safety and Risk Management Advisory Committees said that while there was clear evidence of a statistically significant benefit compared to placebo, there was insufficient information to determine whether the drug was as effective as naproxen.
Data proving the claim that the product had a superior safety profile to other nonsteroidal anti-inflammatory drugs (NSAIDs) was also lacking, the group added.
“I’m struggling with why I would give this drug to my patients instead of naproxen,” said panelist Christy Sandborg, pediatric rheumatology chief at Sanford University School of Medicine.
The company had argued that the presence of nitric oxide in the treatment mitigated the blood pressure problems associated with NSAIDs, and therefore improved its safety.
The FDA, which is expected to make a decision before July 24, is under no obligation to accept the advice.
Copyright Press Association 2010