The FDA issued two new guidances for sponsors of products designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies — and said it considers the delivery system for a topical drug as part of its review, so the whole product is evaluated as a hybrid drug/device.
Sponsors should enroll seasonal-allergy sufferers with at least a two-year history of hay fever—and participants shouldn’t start an immunotherapy or change their regular treatment or dose within at least a month of the trial. Patients with acute or chronic sinusitis, chronic asthma and/or a history of using corticosteroids, leukotriene modifiers (asthma drugs like Singulair) or long-acting antihistamines should probably be excluded from trials, the agency said.
The FDA recommends that “all key trials in the development program, including dose-ranging trials and confirmatory efficacy and safety trials, be conducted with the to-be-marketed product,” the guidance says. “Depending on the nature and extent of the changes, the altered product may be viewed as a new product, necessitating a separate development program with efficacy and safety trials.”
Read the hay fever guidance here: www.fdanews.com/09-05-18-AllergicRhinitis.pdf.
Read the non-allergic rhinitis guidance here: www.fdanews.com/09-05-18-NonallergicRhinitis.pdf. — Bill Myers