The over-the-counter market for dermatological products stands to grow as firms explore options for Rx-to-OTC switches, inspired by recent first-in-class switch approvals and the promise of FDA’s Nonprescription Safe Use Regulatory Expansion (NSURE) 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,” said Susan Levine Coleman, president of NCI Consulting, in an interview.

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

Laura Mahecha, industry manager, healthcare, at market-research firm Kline & Company, noted in a separate interview that the dermatology category often is overlooked because it is not as lucrative as the allergy and heartburn-relief categories, which have seen numerous successful Rx-to-OTC switches since FDA formalized the current process in 1975.

However, dermatology holds potentially low-lying fruit for switch, Mahecha said.

Valeant Pharmaceuticals and GlaxoSmithKline are among firms with dermatological drug products that could be ripe for Rx-to-OTC switch applications, according to Kline & Company’s Laura Mahecha.

According to the analyst, 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 compared with, for example, cholesterol-management drugs, which address an asymptomatic condition and have systemic effects, Mahecha said. Also unlike cholesterol control drugs, dermatological drugs do not have a track record of FDA advisory committee denials.

She noted that 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, patents for which are good through 2020.

GlaxoSmithKline PLC also has potential switch targets in the dermatology area through its subsidiary Stiefel Also see "GSK Gains Foothold In U.S. Skin Care With Stiefel Deal" - HBW Insight, 27 April, 2009..

Despite its challenges, cholesterol management represents an emerging category of interest for switches, as do sleep management and nasal spray products for allergy treatment, according to Mahecha.

Filing of additional switch New Drug Applications for nasal sprays could depend on the market performance of Sanofi’s Nasacort 24HR (triamcinolone nasal), which launched in February without market exclusivity following an October 2013 switch approval ([A#29140205001]).

“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 speculated.

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

Merck & Co., Inc.’s Oxytrol for Women (oxybutynin transdermal system) was another first-in-class switch, approved in January 2013 as an OTC treatment for overactive bladder in women Also see "Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch" - Pink Sheet, 28 January, 2013..

Typically, the Rx-to-OTC switch process requires manufacturers to file NDAs with updated scientific data gleaned through marketing experience under a previous NDA approval.

“FDA experts review the application and determine if that product has a high-enough safety profile and if labeling can be developed so that the medicine can be marketed safely and effectively as an OTC medicine,” the agency explains on its website.

FDA notes that the switch mechanism “provides consumers with convenient, cost-effective access to safe and effective medicines without the required assistance of a healthcare provider,” helping to drive down overall health-care costs.

Dermatology Among Emerging Rx-To-OTC Switch Categories

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