Industry anxiously awaiting FDA decision on DXM’s fate

SILVER SPRING, Md. —While the fact that two Food and Drug Administration advisory committees collectively voted 15 opposed versus nine in favor of scheduling any product containing dextromethorphan suggests that DXM will remain available over the counter, there is no guarantee. The next steps include an FDA review of all material presented during the Sept. 14 meeting, as well as any material submitted outside of that meeting, in a process that typically takes months.

And while the agency heeds the majority vote of its advisory committees more times than not, DXM products may be only one sensational DXM-related-teen-death news story away from being scheduled as a controlled substance. That also may mean that DXM will become available only by prescription—as the FDA noted in its pre-meeting documents that OTC medicines might not be eligible for scheduling under current Controlled Substance Act regulations.

If the legislated migration of pseudoephedrine products behind the pharmacy counter in 2005 is any indicator, scheduling DXM would have a devastating impact on retail sales. For the third quarter ended September 2006, sales of products containing the decongestant PSE already were down by almost half, and the behind the-counter sales only went into effect in June 2006.

Considering that the top three cough syrup manufacturers—Reckitt Benckiser with Delsym, Pfizer Consumer with Robitussin and Procter & Gamble with Vicks—represent 78.7% of the overall cough syrup dollar share, if only those companies posted 50% declines in sales across their respective lines of cough syrup products, and all other sales remained static, that would represent a 39% decline in cough syrup sales alone. (For the 52 weeks ended Sept. 5, sales of cough syrups were up 5.2% to $318.1 million, according to SymphonyIRI Group data across food, drug and mass, excluding Walmart.) That, in turn, would imply a negative 310 basis point impact to all sales of OTC cough-cold products, and that’s across only those three brands.

There is a significant difference between the decongestant PSE and the antitussive DXM, however: A mono-graphed OTC decongestant alternative to PSE already existed; there is no cough suppressant alternative to DXM, save one. That one alternative is the first-generation diphenhydramine—one of the active ingredients in Advil PM indicated for cough that also causes drowsiness.

Retail sales notwithstanding, there would be a far greater impact on healthcare payers and cough sufferers, who now likely would be required to see a doctor for their cough—already the most common complaint for which they visit a physician office and also the most common symptom for which Americans self-medicate, according to Consumer Healthcare Products Association research.