Allermi vs Astepro: Compounded Multi-Ingredient vs OTC Antihistamine
In June 2021, the FDA approved Astepro Allergy (azelastine HCl 205.5 mcg per spray) as the first over-the-counter antihistamine nasal spray Expert In a placebo-controlled trial of azelastine nasal spray 0.15%, onset of symptom relief was reported within 30 minutes of dosing (Shah 2009) Expert Azelastine is a fast-acting intranasal H1-receptor antihistamine that blocks histamine — a chemical released during allergic reactions — to relieve sneezing, itchy nose, runny nose, and nasal congestion Expert In a meta-analysis of three randomized Phase III trials (n=3,398 patients with moderate-to-severe seasonal allergic rhinitis), a single combined intranasal azelastine + fluticasone propionate spray reduced nasal symptoms more than either component alone or placebo, with improvement seen on the first day of treatment Expert Combining azelastine and fluticasone propionate (whether co-administered or as the co-formulated product Dymista / MP29-02) produces greater allergic-rhinitis symptom relief than either agent alone, demonstrated in three Phase III RCTs in moderate-to-severe seasonal allergic rhinitis (n=3,398) Expert Allermi is not currently prescribed during pregnancy or breastfeeding Expert Allermi is currently available to eligible patients ages 13 and older across most US states Expert Each active ingredient in Allermi is individually FDA-approved for the treatment of rhinitis. Allermi formulations are prepared by a state-licensed compounding pharmacy under the federal Food, Drug, and Cosmetic Act (section 503A); compounded drug products themselves are not FDA-approved as fixed-dose combinations and are primarily overseen by state pharmacy boards, with FDA conducting surveillance and for-cause inspections ExpertReferences
- Seidman 2015: Combined therapy systematic review · PubMed https://pubmed.ncbi.nlm.nih.gov/25644617/
This page is grounded in primary literature, reviewed by the BestAllergyNasalSprays editorial team. See our editorial methodology and the public claims library.