FDA makes unprecedented Rx-to-OTC switches

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy. They both address chronic care needs, and they both represent first of their kind medicines to the nonprescription aisle.

The first of the two is Merck Consumer Care’s Oxytrol for Women, a thin, flexible patch for the relief of overactive bladder in women. It is the first and only over-the-counter option that treats OAB symptoms, including urinary incontinence, urgency and frequency. With 20 million OAB sufferers, sales of Oxytrol are projected to reach as high as $50 million.

The second is Chattem’s Nasacort Allergy 24HR — the first and only nasal corticosteroid on OTC shelves. Kline Healthcare’s industry analyst Laura Mahecha projected Nasacort Al-lergy’s annual sales potential to reach as high as $200 million.

“You are seeing a new openness, I think, on the part of the FDA to the switching of products that maybe heretofore wouldn’t have been considered for switch,” Jim Mackey, Merck Consumer Care SVP, U.S. region head, told DSN. “[Oxytrol] is the type of product — treating a chronic condition — that is really a first for the FDA,” said Mackey, who also is chairman of the Consumer Healthcare Products Association. “We’re very favorably disposed to the direction that the FDA is following, and we [as an industry] are very interested in working with them to enable more novel switches in the future.”

“[All told], Rx-to-OTC switches are expected to continue, with more than $10 billion in branded prescription sales likely to switch in the next five years,” said Joseph Papa, Perrigo chairman, CEO and president.

Much of that includes other medicines in the respective classes of Oxytrol (e.g., Pfizer’s Detrol LA) and Nasacort (e.g., Merck’s Nasonex). Pfizer is expected to bring the proton-pump inhibitor Nexium and its $2.1 billion volume in prescription dollars over-the-counter this spring, if not later this year.

Statins, such as Pfizer’s Lipitor, also remain speculative switch potentials despite the FDA having denied statin switches in the past. To date, no switch application has taken advantage of the FDA’s Nonprescription Drug Safe Use Regulatory Expansion that opens the door to utilizing healthcare professionals and technology in expanding the FDA’s conditions of safe use.

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