Cox-2 inhibitor drugs face a bleak future

With the recent recall of Vioxx, a critical challenge facing the Cox-2 inhibitor markets in the United States is the need to conclusively demonstrate the safety of these drugs in long-term use. New analysis from Frost & Sullivan reveals that this market generated revenue of $3.6 billion in 2004. Total market revenues are expected to decrease to $3.13 billion in 2010. It may be pointed out that the German authorities have already issued guidelines restricting prescription of all Cox-2 inhibitors drugs till more data is available. In the United States, however, there is no restriction yet on Cox-2 as a whole, but Bextra, a Cox-2 drug, carries a much stronger warning due to its adverse side effects.

Vioxx was voluntarily recalled after data from a clinical trial revealed that it increased patients' risks of getting heart attacks and strokes. Proving the safety of other Cox-2 inhibitors in long-term use is, therefore, likely to be a difficult task. "Post recall, gaining the approval of the Food and Drug Administration (FDA) for new Cox-2 inhibitors is likely to be a long-drawn out process," says Frost & Sullivan Research Analyst Elisa Perez. "The FDA may even require additional information that will prolong the return on investment (ROI) for these products." (Related article: Americans scared after Vioxx recall)

Extensive clinical trials are necessary to demonstrate the safety of using Cox-2 inhibitors over a prolonged period of time. While these trials will involve additional expenses, they are essential if companies hope to gain the required FDA approval and successfully penetrate the market.

The market also faces the challenge of getting physicians and patients to accept these drugs for use as pain management therapies. "Physicians' reluctance to prescribe Cox-2 inhibitors for pain therapy is increasing," remarks Perez. "A growing amount of data - suggesting that other Cox-2 inhibitors may also carry the risk of cardiovascular adverse effects - is likely to further hurt this market as physicians and patients look to over-the-counter (OTC) products or traditional non-steroidal anti-inflammatory drugs (NSAIDs) for pain management." (Related article: Vioxx alternatives may not be totally safe)

Removing the stigma associated with the adverse side effects of Vioxx, and potentially other Cox-2 inhibitors as well, will require companies to adopt aggressive marketing strategies targeted at physicians as well as patients. Physician education will help in increasing their prescriptions of these therapies, which in turn will make patients more amenable to using them.
"With the recall of Vioxx having impacted not only the Cox-2 inhibitor markets, but also the pharmaceuticals industry as a whole (Related article: Fundamental changes are needed in drug approval process), patient and physician education is critical," remarks Perez. "Pharmaceutical companies should work closely with the FDA to determine the best strategy in the event of recall of a drug. Clinical trials to ensure long-term efficacy and safety are very important for the success of a drug."

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Source: Frost & Sullivan