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FDA panel rules against investigational NSAID after agency reviewers question BP-related benefits of drug
Wednesday, May 19 2010 | Comments
What's This?
A Food and Drug Administration panel voted 16-1 to recommend against approval of NicOx SA's naproxcinod, an investigational nonsteroidal anti-inflammatory drug (NSAID), for use in relieving the signs and symptoms of osteoarthritis.Panelists said there was not enough safety evidence from the company's trials of the NSAID to support its use.
In documents released prior to the meeting, NicOx said naproxcinod combines the established efficacy of the NSAID naproxen with the "well-known effect of nitric oxide," which is intended to improve the safety profile by mitigating the NSAID-induced increase in blood pressure that can occur.
In separate documents, agency reviewers questioned the drug's effect on reducing blood pressure, particularly the variability of the effect seen through the dosing interval.
"Typically drugs with meaningful effects on cardiac outcomes have an effect on systolic and diastolic blood pressure that persists through the dosing interval," they wrote. "In this case the potential impact on cardiac outcomes is unclear."
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