New osteoarthritis drug 'is safe and effective'

Naproxcinod for the treatment of hip osteoarthritis has been found to be safe and effective, its manufacturer has announced after its third Phase III clinical trial.

French pharmaceutical company NicOx said that the drug, a derivative of the non-steroidal anti-inflammatory drug Naproxen, met efficacy targets without raising blood pressure.

The Phase III study found that blood pressure data gathered after treatment with 750mg of naproxcinod was the same as that collected in previous Phase III clinical trials of the drug.

Blood pressure levels were calculated at week two, six and 13. It was found that treatment with 750mg of the drug led to a very similar level of blood pressure as recorded in placebo treatment.

In addition, the level of blood pressure after 750mg of naproxcinod was lower than after 500mg.

Meanwhile, the drug and placebo show the same gastrointestinal (GI) side effects.

NicOx is to combine the data of the three Phase III studies and will submit the findings to the US Food and Drug Administration for approval.

Dr Pascal Pfister, chief scientific officer and head of research and development at NicOx, said: "We believe these are extremely good results, with naproxcinod demonstrating clear efficacy in this difficult type of osteoarthritis patients and showing the same GI adverse event rate as placebo.

"The blood pressure data are consistent with previous studies and we are keenly awaiting the important results of the pre-defined statistical analysis in the next few weeks, following the pooling of the [three studies'] blood pressure data.

"We are confident that these results will clearly demonstrate naproxcinod's non-detrimental blood pressure profile, in contrast to naproxen."

A spokeswoman for the Arthritis Research Campaign said NSAIDs were less commonly prescribed since they had become associated with side effects such as increased risk of heart attack and stroke.

"Any new NSAID has to be proven to be extremely safe - as well as effective," she added.

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