Pharma

Big pharma is finding new ways to expand drug life cycle by transitioning drugs from Rx to OTC

Pharmaceutical companies want to get as much mileage as they can from the drugs they […]

Pharmaceutical companies want to get as much mileage as they can from the drugs they develop before their patents end and generic versions hit the market. In a move to increase the life cycle of certain medications, Merck, Pfizer, Sanofi, Johnson & Johnson and other drug developers are identifying and transitioning prescription drugs to the over-the-counter market, with the blessing of the U.S. Food and Drug Administration.

I spoke with Robert Bianchini, the vice president of global research and development for Merck’s consumer care division at the CONVERGE conference in Philadelphia. It got the greenlight from the U.S. Food and Drug Administration earlier this year to make its drug to treat overactive bladders in women, Oxytrol, available for purchase over the counter. Merck expects it to be available to consumers this fall.

Drug developers are hiring regulatory and medical safety professionals to identify the best OTC candidates. Predictably, the medications that fit the criteria are drugs with few if any side effects or co-morbidities.

Last year, Pfizer paid AstraZeneca $250 million to acquire the global rights to market the over the counter version of its heart burn medication Nexium.

The FDA has been looking at expanding its classification of OTC medications as a way to improve adherence since it estimates that about 20 percent of patients fail to fill their prescription drug prescriptions.

“What we are asking is, should there be more flexibility in the concept of nonprescription drugs,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research on the FDA’s website. “Can we broaden the assistance a consumer gets and increase the types of medicines that might be available over-the-counter?”

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