Petition Answers FDA Questions On Oral Phenylephrine Efficacy, Suggests Removal From Monograph
This article was originally published in The Tan Sheet
A citizen petition says studies have answered the question FDA and advisory committee members asked in 2007, for studies on the most effective dose of PE as a nasal decongestant. The studies show “PE is no more effective than placebo,” the petition says.
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The agency's website soon could include petitions' status in the process, potentially providing some solace to affected sponsors. FDA dockets management staff members are preparing to add live status updates and a listing of all pending citizen petitions to the website.
Researchers say “an optimal dose of PE that is safe and produces clinically significant decongestion is still unknown,” and advocates for removing phenylephrine from the OTC monograph say their study is the proof FDA requested.
FDA's Nonprescription Drugs Advisory Committee recommends additional studies on phenylephrine efficacy for treatment of nasal congestion, although members say current data support the efficacy of the OTC cough/cold ingredient