Staff Writer

Even though an FDA advisory panel has rejected NicOx SA's naproxcinod for osteoarthritis and called for additional studies, company officials said they aren't so sure the FDA is on the same page.

The day after an FDA panel turned solidly thumbs down on naproxcinod's comparative efficacy, the Sophia Antipolis, France-based firm said it plans to meet with the agency as soon as possible to "clarify all these gray areas regarding the need for future studies," CEO Michele Garufi said in a conference call yesterday.

He indicated that there was a "lot of confusion" and "no clear agreement" between the FDA and its advisers on the issue of what the requirements are for approvability of naproxcinod. The company hopes to discuss with the agency the committee's request for additional safety data.

Garufi did not want to speculate what additional studies might be required - a postmarketing, prior marketing or an outcome study. But he did concede that "the chance [of] a straightforward approval is not very high."

Wall Street agreed, knocking down NicOx's shares by nearly 45 percent.

The FDA, which is expected to make its decision by July 24, is not required to take the advice of its advisory committees, but generally follows their recommendation.

Sam Fazelli, a senior research analyst, with Piper Jaffray, stated in a research note that he expects the FDA to follow the committee's advice and that outcome trials would likely be required for naproxcinod approval.

In a 16-to-1 vote, with one abstention, Fazelli noted that the panel's recommendation was "overwhelmingly against U.S. approval for naproxcinod, citing a need for longer-term cardiovascular and gastrointestinal safety data. The panel recommended outcome studies that would delay approval for many years."

But Garufi contended that the safety data generated in the regulatory submission for naproxcinod exceeded the minimum requirements under guidelines by the International Conference on Harmonization for product registration in the U.S., Europe and Japan.

As he has pointed out during the panel meeting, the FDA determined in 2006 that it would not require NicOx to conduct any long-term safety outcome studies, permitting the company instead to use data from naproxen studies, since naproxcinod is essentially a mixture of naproxen and nitric oxide.

During the conference call he reiterated that point, saying that the company had received a letter from the agency indicating that it would be possible to file for approval of naproxcinod without an outcome study.

However, many FDA panel members suggested that the agency should now consider the long-term outcome safety studies before approving naproxcinod, especially since the agency is considering the drug a new molecular entity.

Although Garufi expressed disappointment with the panel's recommendation, he said, "we continue to believe in the strength of the data from our extensive clinical program and have confidence in naproxcinod to provide a useful therapeutic choice for physicians treating patients for osteoarthritis."

The FDA's Arthritis and Drug Safety and Risk Management Advisory Committees agreed that there was clear evidence naproxcinod is more effective than a placebo in treating osteoarthritis. But they said the data were insufficient to determine whether the drug was as effective as naproxen. (See BioWorld Today, May 13, 2010.)

Shares in NicOx (OTC:NICXF) were down $2.97 Thursday, closing at $3.66.