Monday, September 13, 2010

Will Coricidin® OTC (Now A Merck Product) Ultimately Be Subject To Schedule II Regs, After Tomorrow's FDA Advisory Committee Meeting?

Tomorrow, an FDA Advisory Committee will hold a day-long meeting to discuss the abuse potential of the drug dextromethorphan (the active cough suppressant in Merck's Coricidin® OTC and HBP Tablets). The FDA committee will weigh the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. This meeting was scheduled after HHS received a request from the DEA for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of illicit use, and drug abuse, especially among adolescents in the United States.

While all the major OTC cough syrup manufacturers make plain that their drugs should not be taken for recreational use, there is a stong probability that additional regulation of the active ingredient dextromethorphan will be recommended by the FDA committee tomorrow. For example, these OTC products could be moved back "behind the counter" -- even though no prescription would be required. This would force potential abusers to request the item from the pharmacist -- and consequently allow the pharmacist to evaluate whether the purchaser seemed legitimate -- all of which will (very likely) decrease sales volumes for these products, at least to some degree.

It seems an open question as to whether a material amount of the overall sales of such OTC dextromethorphan-containing products are for illicit use. Obviously no pharmaceutical manufacturer (nor the DEA, itself even) discloses projections on that account.

In any event, here are the FDA Advisory Committee's briefing materials (a 132 page, 3.2 Mb PDF file).

If the Advisory Committee makes any surprising recommendations, I'll report them at end of day tomorrow. In any event, here is what Merck's subpage [on the legacy Schering-Plough/New Merck website for Coricidin® (OTC Liquid, and below -- the HBP Tablets)] page has to say about the issue:

. . . .We are proud to provide a product that plays an important role in treating cold and flu symptoms for the 65 million Americans who suffer from hypertension. At the same time, we are tremendously concerned about improper use of one of our products — the reported abuse of CoricidinHBP Cough & Cold tablets by teenagers.

Unfortunately, the abuse of over-the-counter (OTC) products by teens is a long-standing issue. This includes the abuse of products containing Dextromethorphan, one of the active ingredients in Coricidin HBP Cough & Cold. . . .

I'll keep you posted.

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