May 12, 2010 / 8:00 PM / 8 years ago

UPDATE 2-NicOx's arthritis drug rejected by US advisers

* FDA panel recommends against approval

* Drug has potential, but not enough data-FDA panel

* FDA expected to make final decision by July 23 (Adds comments from panelist and FDA, background, share price, byline)

By Susan Heavey

SILVER SPRING, Md., May 12 (Reuters) - NicOx SA’s (NCOX.PA) arthritis drug should not be approved until there is more data to prove it is safe, a U.S. Food and Drug Administration advisory panel said on Wednesday.

The French biotech company wants the FDA’s approval to market its first product, a non-steroidal anti-inflammatory drug (NSAID) called naproxcinod, to treat patients with osteoarthritis with the claim that it has fewer heart risks than some other drugs.

In a 16-1 vote against approval, the panel said that data from the company’s small trials was not sufficient to support safe use of the drug, which may be widely used by older people with other health problems who are likely to be taking other medications. One panelist abstained.

The biotech had been planning to partner with a larger drug maker to market the product.

The FDA will weigh the panel’s recommendation before making its final decision, expected by July 23. It often follows panelists’ advice.

“It’s really something that’s at the margins,” panel member Robert Harrington, a Duke University Medical Center cardiologist, said of the drug. While “there’s actually a lot to be hopeful about,” the company’s data simply did not meet FDA’s standards, he said.

The FDA’s panel of outside medical experts agreed that more options were needed to treat the growing number of people with arthritis, a painful joint disease.

NicOx told the FDA’s panel that naproxcinod was an improved version of naproxen, a widely used NSAID that can increase blood pressure and cause stomach problems. The company said naproxcinod did not cause such side effects because of its nitric oxide-releasing properties.

Such a claim would set the drug apart from dozens of over-the-counter and prescription pain relievers, including AstraZeneca Plc (AZN.L) (AZN.N) and Pozen Inc’s POZN.O recently-approved naproxen-based drug Vimovo.

Nonprescription strength naproxen is sold over the counter as Bayer AG’s (BAYGn.DE) Aleve.

    Naproxcinod would also compete against Pfizer Inc’s (PFE.N) Celebrex, another type of pain medicine known as a COX-2 drug.

    Panelists echoed FDA staff concerns that the biotech’s clinical trials did not prove its drug had a significant heart benefit.

    “There is some tantalizing data that may suggest that there may be a protective effect ... but that will take long-term studies to determine,” said panel chairwoman Kathleen O‘Neil, a pediatric rheumatologist at the University of Oklahoma College of Medicine.

    Most of the panelists agreed that NicOx’s drug appeared to be more effective than a sugar-pill but was not necessarily shown to be as effective as naproxen.

    FDA officials at the meeting called the company’s data “unclear.”

    NicOx officials said they would continue talking with the FDA and would not withdraw their application. They said they were heartened that the panel noted the need for additional medications and that the drug was more effective than a placebo.

    “We remain convinced that this drug is viable,” said Elizabeth Robinson, a co-founder of NicOx and president of the NicOx Research Institute. The company is also seeking approval in Europe. (Reporting by Susan Heavey)

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