Teva's QNASL Nasal Aerosol Improves Pediatric PAR Symptoms
By Cyndi Root
Teva Pharmaceutical announced in a press release that pediatric patients taking QNASL (beclomethasone dipropionate) saw fewer symptoms after treatment. The Phase 3 clinical trial of children between the ages of 4 and 11 demonstrated evidence of QNASL’s safety and efficacy for Teva’s supplemental New Drug Application (sNDA) for perennial allergic rhinitis (PAR), or “year round” allergies. Teva will present the data from the study at the American College of Allergy, Asthma, & Immunology (ACAAI) Annual Scientific Meeting in Atlanta, Georgia. Dr. William Berger, study investigator from the Allergy and Asthma Associates of Southern California in Mission Viejo, California, said, “This treatment features a low-dose formulation and ‘waterless’ aerosol delivery, making it a promising option for children with allergic rhinitis.”
QNASL
QNASL was first approved in March 2012 for seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. In May 2014, the Food and Drug Administration (FDA) accepted Teva’s sNDA to treat both PAR and SAR in children 4-11 years of age. QNASL is a waterless aerosol intranasal corticosteroid spray. The active ingredient is beclomethasone, a man-made (synthetic) corticosteroid, which works to limit inflammation. The delivery system is waterless due to a propellant, hydrofluoroalkane (HFA). When administered intra-nasally, the agent works to tamp down inflammation and its associated unpleasant symptoms of stuffy nose, runny nose, nasal itching, and sneezing.
QNASL Study
Teva’s Phase 3 study to support its sNDA for pediatric patients with PAR was a 12-week, placebo-controlled trial with 547 patients. Investigators dosed the young allergy sufferers with two actuations of the aerosol, one in each nostril. They measured symptoms at 6 and 12 weeks using average morning (AM) and evening (PM) reflective and instantaneous nasal symptom scores. The results showed that patients treated with QNASL showed significantly improved symptoms compared to the placebo-treated patients. The safety profile was deemed good and the medication was well-tolerated.
Teva Studies
Teva has other studies running for different agents in varying indications. In September 2014, Teva announced follow-up data from a trial of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) who were treated with laquinimod in Phase 2, Phase 3, and open-label extension studies for two or more years. The safety analysis found that safety risks were most prevalent at the beginning of treatment.