This site is intended for health professionals only!

Published on 13 May 2010

Share this story:
Twitter
LinkedIn

Panel advises against NicOx drug

teaser

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
NicOx



Most read




Latest Issue

Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine
Share this story:
Twitter
LinkedIn