Study information on celecobix
According to a new study published in the New England Journal of Medicine, celecobix (Celebrex) is as safe as, and "may even be safer than the alternatives," of ibuprofen and naproxen. From the article in the Washington Post, "there is evidence that Celebrex is less likely than the other two to cause kidney and gastrointestinal problems associated with NSAIDS."
All of this should be of interest from a regulatory perspective as well. If celecobix can replace NSAIDS, it can potentially have implications in clinical trials, and as such, there are many interactions which companies will need to understand, including the drug/drug interactions. Will they be similar to the NSAIDS, or will they differ. As yet, this is just a published study, but it can impact the future of drug development. It behooves all Regulatory professionals, especially consultants to keep abreast of these kinds of studies as much as it does to keep up with changes to 21CFR.
