Tough Times Ahead for Cox-2 Inhibitors

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.

"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."

"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."

"With the recall of Vioxx having impacted not only the Cox-2 inhibitor markets, but also the pharmaceuticals industry as a whole, 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."