FDA Advisory Committee Recommends First Rx-to-OTC Steroid in Nearly 60 Years

On July 29, 2013 the FDA’s Nonprescription Drugs Advisory Committee (NDAC) recommended that Sanofi-Aventis’ Nasacort AQ be approved for over-the-counter sale. If the FDA endorses the NDAC decision, as it usually does, it will represent something of a regulatory milestone due to the fact that Nasacort’s active ingredient, triamcinolone acetonide, is a corticosteroid and the agency has been very reluctant to allow consumers direct access to products in this class.

To date, the only steroid to undergo an Rx-to-OTC switch in the U.S. is low strength topical hydrocortisone which was reclassified in 1956. In 2005, an agency advisory committee evaluated the possibility of allowing OTC sale of additional topical steroids and rejected the option due primarily to concerns over suppression of the hypothalamic-pituitary-adrenal (HPA) axis and growth suppression. A majority of panelists voted that they would recommend against OTC status unless trials showed zero observed events per 1,000 patients. Of note, HPA suppression is much higher in topical steroids than when the drug is administered nasally, as would be the case for Nasacort: 30-80% of topical patients show some degree of HPA suppression whereas the connection is largely hypothetical with inhaled steroid use.

Despite suggestions that inhaled steroids may have a lower side-effect burden, other recent Rx-to-OTC switch efforts have failed before the final regulatory stage: in 1997, GlaxoWellcome (as the company was then known) voluntarily withdrew a request for review of Beconase (beclomethasone) after two longitudinal studies which showed a previously unseen growth suppression effect. (The same studies led to labeling about growth suppression for all orally and nasally inhaled corticosteroids.) GSK also considered an Rx-to-OTC switch for Flonase as early as 2003 but halted development after concluding that the FDA would reject an application.

Todd Clark
Todd Clark


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