OTC MENTHOL NEEDS MULTIPLE DOSE STUDY TO SUPPORT DECONGESTANT USE
OTC MENTHOL NEEDS MULTIPLE DOSE STUDY TO SUPPORT DECONGESTANT USE, FDA told Smith-Kline Beecham in a recent letter. Responding to a petition from Beecham to include 10 mg menthol in the final monograph for OTC nasal decongestants, FDA said that "another study involving multiple doses is needed to support effectiveness." The petition was submitted on Feb. 10, 1988. FDA said that the study should "be done using the same dosage and given at the same time intervals as proposed for label directions" (the company proposed a 10 mg lozenge taken every two hours as needed). A "three-day study," FDA said, "is necessary to show effectiveness as a nasal decongestant if indicated for colds and seven days if indicated for allergies." The agency also suggested that the study look at the potential for rebound congestion. FDA noted that SmithKline Beecham's petition "will not be addressed in the final monograph...because the final monograph for OTC nasal decongestant drug products may [be published] prior to resolution of the...discussed issues." In support of the requested inclusion of menthol in the monograph, Beecham had submitted one study using a single dose of menthol. Results of the study, FDA said, were "supportive of the effectiveness of a 10 mg menthol lozenge," but "not sufficient to reclassify the ingredient from Category III to Category I." In addition to its traditional two-study requirement, the agency cited the fact that the study did not evaluate the multiple dose regimen proposed by the company ("every two hours as needed"). The submitted study measured nasal flow/resistance at 15, 30, 60, 90 and 120 minutes after treatment with a 10 mg menthol lozenge. Results, FDA said, "support a two-hour duration of action from a single dose." The agency reported that the study found a "negligible change from baseline" in subjects that received placebo, whereas "menthol reduced nasal flow/resistance 1.00 to 1.57 cm H20/L/sec over the interval 15 minutes to 120 minutes." * Menthol is the active ingredient in SmithKline Beecham's N'ICE lozenges. The ingredient is also contained in a number of other OTC cold products, including Rich-Vicks' Vicks cough drops and throat lozenges, Marion Merrell-Dow's Cepastat lozenges, and Warner-Lambert's Halls Mentho-Lyptus cough drops.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
Sign in to continue reading.
Need a specific report?
1000+ reports available
New to Pink Sheet?
Start a free trial today!
Register for our free email digests: