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Companies -
Biotechnology Companies
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Written by Hugh McManus
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Monday, 10 May 2010 17:15 |
The FDA issued the Review Committee background package for naproxcinod earlier today; here's the link.
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/UCM211466.pdf Naproxcinod is a drug developed by the French company NicOx.
Based on what I read, I'd say that competing therapies don't appear to have anything to worry about. The reviewer concluded that from the analysis of the data, claims that naproxcinod performed better than a competing therapy were not supported. The drug was effective in reducing the symptoms of osteoarthritis and the safety profile is similar to other NSAID drugs. The data also didn't support the idea that the drug is an antihypertensive agent.
Based on what I read in the review, there is nothing special about this drug. The agency asked the committee to analyze very specific topics, so they may not commment on whether it should be approved; but based on my reading of the data, it doesn't seem to me that this drug would introduce anything new to the market were it to be approved. Based on what has been made public thus far, I would not be surprised to see the FDA decline to give marketing approval for this drug.
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