OTC Antitussive Menthol Chewing Gum Requires NDA Deviation – FDA
This article was originally published in The Tan Sheet
Executive Summary
A menthol-containing topical antitussive drug with chewing gum as a delivery form necessitates submission of an NDA deviation, FDA states
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A menthol-containing topical antitussive drug with chewing gum as a delivery form necessitates submission of an NDA deviation, FDA states. Both in vitro and in vivo data on the release of menthol from chewing gum are needed to substantiate such a dosage form, the agency says in a Nov. 9 denial of a citizen petition requesting inclusion of gum in the Cough/Cold (Antitussive) Products final monograph. Submitted by McDermott, Will & Emery (Washington, D.C.) on behalf of an unnamed gum manufacturer, the May 25 petition asked FDA to amend the monograph to allow a chewing gum that releases 5 mg-10 mg menthol in 20 minutes, on par with marketed lozenges (1 (Also see "Chewing Gum Acceptable Menthol Delivery Form, Petitioners Suggest" - Pink Sheet, 11 Jun, 2001.), p. 16). The petition included in vitro test data suggesting similar menthol release rates from the gum dosage form when compared with three lozenges containing the active ingredient. However, FDA says the product is "limited to an NDA deviation because assurance is needed that an individual piece of gum containing 17 mg of menthol releases the intended monograph dosage quantity of 5 mg of menthol in 20 minutes." "We do not agree that the release mechanism for chewing gum is identical to lozenges," FDA states, noting while both affect respiratory tract nerve receptors, the chewing mechanism required of gum differs from the slow dissolution of a lozenge. FDA also deems the petitioners' data "insufficient to demonstrate that the rate and extent o f release of menthol for chewing gum are comparable to that of a menthol-containing lozenge." In order to satisfy a "dNDA," FDA says applicants must show "a correlation between the in vitro data and actual in vivo extractions and...an in vivo determination of menthol release from the gum product compared to a similar product," such as a lozenge. An NDA deviation is a relatively new mechanism that enables applicants to file only data necessary to support a change in a monographed drug instead of all product data, as would be required with an NDA. The first product approved under a dNDA was Pfizer's Maximum Strength Rid Mousse in March 2000 (2 (Also see "Pfizer Rid Mousse Pediculicide Approved Under "NDA Deviation"" - Pink Sheet, 13 Mar, 2000.), p. 4). |