Demonstration of therapeutic equivalence of generic and innovator beclomethasone in seasonal allergic rhinitis. SAR Study Group.

BACKGROUND

Although generic formulations of drugs are chemically equivalent, they may not be bioequivalent to the innovator. Since bioequivalence of intranasal corticosteroids has been difficult to demonstrate by pharmacokinetic methods, clinical trials have been necessary to compare generic and innovator agents.

OBJECTIVE

We therefore designed a multicenter, randomized double-blind, parallel-group placebo-controlled study to examine the therapeutic equivalence of generic beclomethasone diproprionate to the innovator.

METHODS

A total of 518 patients, ages 12 to 60, with ragweed-induced seasonal allergic rhinitis from eight centers were randomized to receive intranasal generic or innovator beclomethasone 42 microg, 84 microg or placebo twice daily for 6 weeks. Efficacy was assessed by means of rhinitis symptom scores as recorded in patient diaries. Adverse events were recorded throughout the study to assess safety.

RESULTS

Mean rhinitis composite symptom scores (congestion, postnasal drip, runny nose, and sneezing) were significantly lower in patients receiving 42 microg (P = .0003) or 84 microg (P = .0001) beclomethasone twice daily compared with placebo. Generic beclomethasone was equivalent therapeutically to the innovator in alleviating nasal congestion (42 microg and 84 microg doses), postnasal drip (84 microg dose), runny nose (84 microg dose), sneezing (42 microg and 84 microg doses) and mean composite (42 microg and 84 microg doses) symptom scores during the 6-week study period. Similar and equivalent efficacy was also demonstrated during the 5-day period of peak pollen counts at each site. The type and incidence of drug-related adverse events were similar for both beclomethasone treatment groups and did not differ significantly from placebo in severity and frequency.

CONCLUSIONS

Generic beclomethasone was therapeutically equivalent to the innovator in regards to both efficacy and side effect profile in the treatment of ragweed-induced allergic rhinitis.