FDA's recent decision that the breakthrough UVA filtering ingredient ecamsule is "eligible for inclusion" in the OTC sunscreen drug monograph pending a safety and efficacy evaluation offers innovators more flexibility and could level the playing field among competing U.S. manufacturers.

The agency has determined ecamsule (terephthalylidene dicamphor sulfonic acid) eligible for inclusion in the OTC sunscreen drug monograph as a single active ingredient and with other generally-recognized-as-safe-and-effective sunscreen actives in concentrations up to 10 percent, based on its review of a time and extent application filed by L'Oreal, according to a Sept. 12 Federal Register notice.

The ingredient absorbs middle range UVA waves and is one of the most effective UVA filtering ingredients available today, according to experts.

Before the agency decides whether to add ecamsule to the monograph, it seeks data about the safety and efficacy of ecamsule as a single and combined active ingredient in sunscreen, according to the notice. Comments and data are due to FDA by Dec. 11.

L'Oreal, which owns ecamsule, explains in the TEA that ecamsule-containing sunscreen products have been marketed to consumers in 48 countries for more than five years. Indeed European and Canadian consumers could buy products with ecamsule since 1993, according to the Center for Drug Evaluation and Research's review of L'Oreal's TEA.

L'Oreal submitted the TEA to include ecamsule in the OTC monograph last September - a little more than a year after FDA approved a new drug application permitting the firm to sell ecamsule products in the U.S.

One month after the company submitted the TEA it launched Revitalift UV Daily Moisturizing Cream - the first item in the U.S. to contain ecamsule. Revitalift includes two percent ecamsule, significantly less than the 10 percent maximum FDA is considering for approval in the OTC monograph.

Other L'Oreal products sold in the U.S. that include ecamsule include Anthelios SX Daily Moisturizing Cream with Sunscreen SPF 15, Anthelios 40 Sunscreen, Vichy Capital Soleil SPF 20 with Mexoryl SX Daily Moisturizing cream SPF 20, Kiehl's UV Protective Suncare Sunscreen Cream SPF 20 and SkinCeuticals Active UV Defense SPF 15.

In the L'Oreal products, ecamsule is combined with two other active ingredients to protect against short- and long-wave UVA radiation. The other two ingredients, avobenzone and octocrylene, are both recognized as GRASE under the current OTC sunscreen monograph, according to FDA.

The combination, patented by L'Oreal as Mexoryl SX , is a stable UVA sun filter that is "virtually impervious ... to the action of solar energy," and is hydrosoluble, so it combines well with liposoluble filters (¹ Also see "L’Oréal’s Anthelios SX Will Launch Following FDA Approval Of UVA Filter" - HBW Insight, 31 July, 2006., p. 3).

Currently L'Oreal is the only manufacturer to sell ecamsule-containing products in the U.S. - an exclusive arrangement that will end if ecamsule is added to the monograph - especially considering the company's patents will expire soon. The majority of L'Oreal's patents on ecamsule products expire in July and October 2009. The longest protects exclusivity through March 2011.

Despite those pending expirations, L'Oreal wants to include ecamsule/Mexoryl SX in the monograph so that it has the flexibility to make ecamsule products available to all its consumers through all of its brands and product categories, Alan Meyers, senior vice president of L'Oreal USA's research and development, said in an email. If it is not added to the monograph, the only way L'Oreal can include ecamsule in all its products is to file separate NDAs.

If FDA includes ecamsule in the monograph and it becomes available to other sunscreen manufacturers, it "would be a considerable stimulus" for sunscreen innovation, said Joseph Stanfield, president of Suncare Research Laboratories in North Carolina.

"The only other absorber that is available for companies to use in the U.S. is avobenzone, which ... absorbs a little longer wave length. So when you put ecamsule with the avobenzone you have a real good formula for absorbing UVA," he added.

Ecamsule also is appealing to innovators because it is highly photostable and has a large molecular weight. This means it will not absorb into the blood stream, added Henry Lim, chairman of the dermatology department at Henry Form Hospital in Detroit.

- Elizabeth Crawford (e.crawford@elsevier.com)

FDA Deems UVA Filter Ecamsule Eligible For Monograph, Seeks Data

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