NicOx: FDA panel negative opinion casts future of osteoarthritis drug into doubt
17th May 2010 12:35
In September 2009, NicOx submitted a New Drug Application to the FDA for naproxcinod as a potential treatment for the signs and symptoms of osteoarthritis, supported by data from three large Phase III studies. However, due to insufficient safety data, the overwhelming majority of the FDA's advisory committee has opted to not recommend the drug for approval. The committee noted that the data were unclear, highlighting the imprecise interpretation of blood profile data for this new type of compound. NicOx will be hoping to clarify this with the FDA in the coming weeks.
The decision represents a major setback for the future commercial potential of naproxcinod, especially as the company has been gearing up to a US launch. Naproxcinod is the first in a new class of anti-inflammatory agents known as cyclo-oxygenase-inhibiting nitric oxide donators. As NicOx's lead candidate, naproxcinod generally received positive expert opinion throughout its clinical development and demonstrated a beneficial blood pressure profile in clinical studies. However, the FDA committee felt that naproxcinod did not generate enough data to show that it was non-inferior to standard naproxen, and has demanded further long-term cardiovascular outcomes. This will be costly and time-consuming for NicOx.
In 2007, the osteoarthritis market was valued at $4 billion in the seven major markets, with the non-steroidal anti-inflammatory drug (NSAID) class generating almost a quarter of sales. Despite this, however, naproxcinod risked entering a mature, genericized sector. Indeed, more recent market research (2009; click here for information on the report) has found that there were pressing unmet needs among physicians for drugs with improved gastrointestinal and cardiovascular side-effect profiles.
The decision is particularly significant following the withdrawal of Merck's Vioxx (rofecoxib) in 2004, a cyclooxgenase-2 selective NSAID which was found to increase the risk of cardiovascular disease in patients being treated for chronic or acute pain. The FDA's latest negative recommendation further demonstrates how stringent the safety profile is for new therapies in the osteoarthritis market.
The future for naproxcinod now looks bleak and the drug's commercial and clinical potential now appears dubious. While a decision from the European Medicines Agency in December 2009 retains some near-term hope for naproxcinod, a positive outcome for the NSAID in the EU is far from certain. The FDA is expected to issue NicOx with a Complete Response Letter on July 24, demanding extensive additional data.
Related research
- Stakeholder Insight: Osteoarthritis - Drug development lags behind rising osteoarthritis population priced $15,200 [further details]
- The osteoarthritis market - COX-2 inhibibitors, NSAIDs and corticosteroids $15,200 [further details]
- Nitric Oxide - Therapeutics, Markets and Companies $2,800 [further details]
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