Dermatology, Nasal Sprays Among Emerging OTC Switch Categories

FDA threw the switch floodgates open with the NSURE initiative and it has fueled interest with the recent first-in-class switches of Nasacort and Oxytrol for Women. Likely categories for successful switches include dermatology, nasal sprays in allergy, sleep, migraine relief and cholesterol management.

Firms are exploring switch options in emerging categories including dermatology and nasal spray products, inspired by the recent first-in-class Rx-to-OTC switches for Nasacort 24HR and Oxytrol for Women and the promise presented in FDA’s Nonprescription Drug Safe Use Expansion initiative.

“I would say the flood gates are pretty open” right now for Rx-to-OTC switch applications, in part because firms see “an opening in increased receptivity from FDA to switch,” says Susan Levine Coleman, president of NCI Consulting.

Firms are exploring “an extraordinary number of options” for potential switches, she added.

In addition to dermatology and nasal spray products, potential switch options are emerging in the categories of sleep and cholesterol management, says Laura Mahecha, industry manager, health care, at Kline Management Consulting Market Research.

The dermatology category often is overlooked because it is not as lucrative as the allergy and heartburn relief categories, but it holds potentially low-lying fruit for switch, Mahecha said.

She said topically applied treatments for eczema, psoriasis and acne are not systemic drugs that work throughout the body and therefore do not face the same safety concerns frequently raised by FDA during switch reviews. Likewise, these are conditions that consumers can readily recognize and understand because they have been diagnosed and have treated themselves with expensive prescription medications for years.

Topical dermatological drugs are not as contentious or complicated to switch as a cholesterol management drug, for example, which is an asymptomatic condition and a systemic drug that acts throughout the body, Mahecha said. Also unlike cholesterol control drugs, dermatological drugs do not have a track record of FDA advisory committee denials.

She noted Valeant Pharmaceuticals International Inc. offers several Rx dermatological products, including Elidel (pimercrolimus cream) for eczema, which is patent protected through 2018; Acanya Gel (clindamycin phosphate and benzoyl peroxide) for acne with patents through 2029; Atralin (tretinoin) for acne with patents through 2014; and Renova (tretinoin cream) for smoothing skin with patents through 2020.

GlaxoSmithKline PLC also has potential switch targets in the dermatology area through its subsidiary Stiefel (Also see "Glaxo Augments OTCs With Stiefel Deal, Gains Strong Dermatology Foothold" - Pink Sheet, 27 Apr, 2009.).

More Nasal Sprays?

Another potential area for switch is additional nasal sprays in the allergy category. Filing of additional switch NDAs in the category could depend on the market performance of Sanofi’s Nasacort 24HR (triamcinolone nasal), which launched in February without market exclusivity .

“If that goes really well, and turns into a big product despite private label competition, you might see Flonase and Nasonex or some of those other allergy nasal spray products try to enter that already crowded category,” Mahecha said.

Again she noted the allergy category offers easier switches because many consumers understand the category and how to self-treat their allergies.

Difficult Categories Offer Hope

Migraine management is a slightly more complicated but also promising switch category, Mahecha said. She noted GSK could try to switch Imitrex, which lost patent exclusivity in February 2009 and was predicted by analysts at Morgan Stanley to switch as early as 2012 (Also see "Brands With Probability of Near Term Rx-To-OTC Switch" - Pink Sheet, 4 Feb, 2008.). It gained switch approval in the U.K. in 2006.

The sleep category also is appealing to firms, but difficult to navigate for switch because several drugs are controlled substances and ripe for abuse.

Nonetheless, Mahecha suggests Takeda Pharmaceutical Co. Ltd.’s Rozerem is a potential candidate because it works with users’ sleep-wake cycle as opposed to affecting the brain like other controlled substances in the category, including Ambien and Lunesta. Rozerem also is a strong candidate for switch because it goes off patent in 2019.

If switched, Rozerem would enter a relatively crowded OTC category, but Mahecha does not see this as an obstacle.

“Sleep is a huge category, like allergy, that grows and grows because more people suffer from more problems and I think that will just continue. … People are so wired from the morning to night and are falling asleep with their iPads and phones in the bed, so they are not having restful sleep,” she said. This is why sales of melatonin products and Procter & Gamble Co.’s OTC sleep aid Zzzquil (diphenhydramine HCl), which launched in June 2012, “took off like crazy.”

Finally, Mahecha sees some potential for switch in the cholesterol management category, although she notes these products face significant challenges.

Pfizer Inc. likely is banking on FDA’s interest in innovative switches through NSURE to move its cholesterol managing statin Lipitor OTC. The firm currently is conducting a large actual-use trial of the drug, with results due in December, that will influence the ultimate decision whether to apply for switch (Also see "Pfizer Lipitor OTC Bid Would Face FDA Evolving On Switch Innovation" - Pink Sheet, 4 Mar, 2014.).

[Editor’s note: Each week, “The Pink Sheet” DAILY features a story from “The Tan Sheet,” highlighting an issue in the consumer medicines or nutritional supplements sectors.]