An FDA advisory panel unanimously agreed that oral phenylephrine is not effective at relieving nasal stuffiness. The decision, voted on during FDA’s Nonprescription Drugs Advisory Committee meeting, could result in the removal of oral formulations of phenylephrine.
Leslie Hendeles, PharmD, from the University of Florida, said it’s important for the public to know that there are still several effective OTC products already available to relieve congestion, including phenylephrine and oxymetazoline nasal spray decongestants as well as oral pseudoephedrine. The potential removal of oral phenylephrine would not deprive patients, according to Hendeles.
“It is only the oral route that is not effective, because 99% of the parent drug is inactivated in the gut and during the first pass through the liver,” said Hendeles.
Hendeles and Randy Hatton, PharmD, led a University of Florida’s citizen petition that was filed in 2015 requesting the removal of oral phenylephrine from the final monograph for OTC nasal decongestant products. APhA submitted a letter to FDA in support of this. In the APhA letter, which was sent ahead of the FDA meeting to consider the data on oral phenylephrine, APhA noted that the CARES Act of 2020 included provisions that modified the way OTC monograph drugs are regulated. “Specifically, the CARES Act replaced the standard rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. This process allows FDA to review nonprescription drugs, like oral phenylephrine, and remove nonprescription drug products that do not meet the legal standard for OTC use,” the letter stated.
The FDA advisory committee focused on whether “the pharmacological effect of the drug, when used under adequate directions for use and warnings against unsafe use, will provide clinically significant relief of the type claimed.” Using that standard, “we have now come to the initial conclusion that orally administered PE [phenylephrine] is not effective as a nasal decongestant at the monographed dosage (10 mg of PE hydrochloride every 4 hours) as well as at doses up to 40 mg (dosed every 4 hours),” noted FDA documents ahead of the meeting.
FDA scientists presented the results of five studies conducted over the past two decades on the effectiveness of oral phenylephrine. All the studies found it to be no more effective than a placebo. FDA members also heard testimony from industry, physicians, pharmacists, and other experts during the 2-day meeting.
FDA will now need to decide whether to revoke the drug’s OTC designation as “generally recognized as safe and effective.” The designation, typically used for older drugs, allows drugmakers to include an ingredient in OTC products without the need to file an FDA application.