Greer short ragweed sublingual allergen immunotherapy liquid: Phase III data

A double-blind, North American Phase III trial in 429 patients ages 18-55 with moderate to severe allergic rhinoconjunctivitis showed that once-daily RW-SAIL met the primary endpoint of reducing average TCS from baseline over the entire ragweed pollen season vs. placebo (placebo-adjusted reduction of 43%, p=0.0005). On secondary endpoints, RW-SAIL led to placebo-adjusted reductions of 42% in average TCS during peak season (p=0.0007), 42% in average daily symptom score during the entire season (p=0.0022) and 41% in average daily symptom score during peak season (p=0.0022).

The incidence of adverse events was similar between treatment arms and the most common adverse events were mild to moderate oral/ throat itching, edema, hives or rash and diarrhea. No treatment-related serious adverse events were reported and there was no occurrence of anaphylaxis. The trial enrolled patients with moderate to severe allergic rhinoconjunctivitis attributable to ragweed pollen that normally required anti-allergy medications to receive once-daily RW-SAIL or placebo beginning 8-16 weeks before and through the end of the ragweed pollen season. Data were published in Journal of Allergy and Clinical Immunology. ...