Over-the-counter (OTC) drugs often start out as prescription medications. If a prescription drug sees widespread use, and its side effects and safety profile are well characterized, the US Food and Drug Administration (FDA) may approve the drug’s conversion to OTC availability.
This approval, however, comes with a few stipulations: the drug must be deemed as safe for the broad population, and the drug must be offered at the lowest effective dose to minimize the risk of adverse events. Still, a prescription to OTC conversion can result in boosted sales for pharmaceutical companies.
Pfizer’s recently-completed PRECISION study aimed to compare the risk profile of its painkiller, Celebrex, with other nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen and naproxen. As NSAIDs are known to increase the risk of heart attack and stroke in patients taking prescription doses for long periods of time, the study coordinators were specifically looking to characterize any adverse cardiovascular effects associated with Celebrex.
The results of the PRECISION study showed that Celebrex is as safe as the two other NSAIDs tested. Just over two percent (2.3 percent) of patients taking Celebrex died as a result of a cardiovascular event, compared to 2.7 percent of ibuprofen patients, and 2.5 percent of those taking naproxen.
“NSAIDs are an important treatment option for millions of arthritis patients around the globe,” said Dr. Freda Lewis-Hall, chief medical officer and executive vice president of Pfizer Inc. “The results of the PRECISION study underscore the cardiovascular and gastrointestinal safety of Celebrex for the long-term treatment of chronic arthritic conditions.”
Celebrex was approved by the FDA 17 years ago, and has since been the subject of a number of clinical trials and safety studies. Based on its similar risk-benefit profile compared to other OTC NSAIDs, and it’s lack of liver toxicity compared to acetaminophen, Celebrex could be ripe for an OTC conversion.
In addition to providing consumers with another OTC pain medication, the potential future availability of Celebrex on the shelf would be a big win for payers. As OTC medications are not covered by insurance companies, they wouldn’t need to pay for this version of Celebrex.