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news.Merck's investigational allergy immunotherapy tablet (AIT) has reduced the total combined score that measured nasal and eye symptoms and use of rescue allergy medicines, compared to placebo, in ragweed-allergic adults with or without asthma.
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AIT, a dissolvable oral tablet is being studied to determine whether AIT may help to prevent allergy symptoms by stimulating an immune response against targeted allergens.
Phase III trial is a multicenter double-blind randomized placebo-controlled parallel group study that included 565 adults aged 18 to 50 years with ragweed-induced allergic rhinoconjunctivitis.
The study is designed to evaluate the efficacy and safety of once-daily tablet of ragweed allergen extract at a dose of 6Amb a 1-U or 12Amb a 1-U or placebo.
Patients treated with ragweed AIT 12Amb a 1-U or AIT 6Amb a 1-U showed 27% and 21% reductions in total combined score, respectively, compared to placebo.
Both the doses of ragweed AIT also reported 45% and 34% reductions in daily medication score, respectively, relative to placebo.
Merck Research Laboratories Respiratory & Immunology senior vice president and franchise head Rupert Vessey said patients who took AIT in the study experienced reduction in the nasal and eye symptoms caused by ragweed allergies.
The company plans to file New Drug Applications for its ragweed and grass AITs with the US Food and Drug Administration in 2013.