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.
Baby boomers, preventive solutions drive OTC
Overall, the OTC sector in 2013 realized $40.2 billion in sales, according to data culled from OTC categories tracked by IRI. That’s up from the $38.3 billion that DSN reported last year. The 2013 sales numbers reflect a strong 2012-2013 cough-cold season and the relaunch of Tylenol, Excedrin and Motrin.
The aging of the baby boomer is reflected across the best-selling OTC brands. Two of the top five brands are pain relievers. The adult incontinence brand Poise holds the No. 2 spot in terms of OTC sales, and standing at No. 6 is Ensure’s RTD protein shakes.
While baby boomers will continue to drive the pound of cure, overall more Americans are more often seeking their ounce of prevention. According to Bain & Co.’s recent Healthy Living Survey, 75% of consumers are in pursuit of a healthier lifestyle. Take that predominant mindset, coupled with the outcomes-driven preventive focus associated with the Affordable Care Act, and you have a formula for OTC success at retail pharmacy.
Retailers are already supplying preventive health solutions. H-E-B and Rediclinic last month augmented its Weigh Forward weight-loss clinic with an online component. Also, GlaxoSmithKline and Walgreens teamed up to launch Sponsorship to Quit, a free online quit-smoking program.
Reckitt Benckiser acquires K-Y
SLOUGH, England — Reckitt Benckiser announced that it would acquire global rights to personal lubricant brand K-Y from Johnson & Johnson. The transaction is expected to close mid-2014.
K-Y started as a prescription medical device in 1917 before switching to the OTC category in 1980. K-Y will join Reckitt Benckiser brand Durex in the sexual wellness category.
Net sales of K-Y in 2013 totaled greater than $100 million. It is sold in more than 50 countries around the globe, with the United States, Canada and Brazil accounting for the top majority of 2013 sales.