Sixteen years after pharmacists from the University of Florida College of Pharmacy in Gainesville petitioned the FDA to require new efficacy studies of an ingredient in decongestants, their efforts came to fruition. In September, an FDA panel unanimously declared the ingredient ineffective.
Oral phenylephrine — often found in drugs like Sudafed — was first approved as a decongestant in 1976, but since then data has revealed it is much less effective than initially thought.
So in 2007, Leslie Hendeles, PharmD, and Randy Hatton, PharmD, from UF's College of Pharmacy petitioned the FDA. The agency did recommend further safety and efficacy studies of the ingredient, but they note in an Oct. 27 news release from the American Society of Health-System Pharmacists, that at the time it did not appear the agency prioritized the matter.
A 2015 study that "showed that four times the maximum FDA-approved dose of phenylephrine was no different than placebo," Dr. Hendeles said, prompted a citizen petition to the agency requesting the removal of oral phenylephrine from FDA monographs. That too fell short of leading to a formal change by the federal agency.
However, it did lead to further research led by the Nonprescription Drug Advisory Committee in September, which found that the ingredient was not effective orally, only when administered via the nasal cavity. This ultimately drove the FDA's recent decision.
The advisory committee, after reviewing all of the evidence, voted unanimously to validate what we first said nearly 20 years ago," Dr. Hatton stated in the release.
The two pharmacists noted that other drugs that may be ineffective are still on the market, like guaifenesin — an ingredient in products like Mucinex — but their decades-long work in at least one area has finally been realized.