Fast-dissolving allergy immunotherapy tablet for sublingual administration has been, and are currently being, developed by the industry in comprehensive clinical development programs designed to satisfy current requirements for market authorization.
Currently, three allergy immunotherapy tablet products have been developed in accordance with applicable regulatory requirements for marketing authorization. The SQ grass allergy immunotherapy tablet (ALK, Denmark) and a ragweed allergy immunotherapy tablet in the same formulation, and the 5-grass allergy immunotherapy tablet (Stallergenes, France). The SQ grass allergy immunotherapy tablet is a fast-dissolving tablet of a freeze-dried formulation containing grass pollen extract from one grass species, Phleum pratense, whereas the 5-grass allergy immunotherapy tablet is a multiparticulate tablet produced by compression and containing a mixture of pollen from five homologous grass species with high IgE cross-reactivity.
For the SQ grass allergy immunotherapy tablet , simultaneous authorization in 27 European countries was based on Phase I–III studies comprising almost 1800 patients. A large dose-finding trial (N = 855 patients) established the optimal dose, which was then documented in a large safety and efficacy study (N = 634 patients). For the 5-grass allergy immunotherapy tablet , the clinical development program comprised Phase I, II, and III studies, including 1350 patients. A large dose-finding trial (N = 628 patients) established the optimal dose, which was then documented in a large safety and efficacy study (N = 633 patients).
A allergy immunotherapy tablet for the treatment of ragweed pollen allergy has also been developed. Two large randomized, double-blinded placebo-controlled trials have been published demonstrating clinical efficacy in adult patients with ragweed pollen-induced rhinitis with or without conjunctivitis.
The safety profile of the allergy immunotherapy tablet support at-home use once the first dose is tolerated when administered under physician supervision. This procedure allows for not only possible treatment of any immediate adverse effects in sensitive patients, but also discussion of local adverse effects, such as mild itching and mild swelling of the lips and floor of the mouth, which are common but usually of short duration and, in most patients, cease to occur after a few weeks of treatment.
Larsen J N et al. Allergy immunotherapy: the future of allergy treatment[J]. Drug discovery today, 2016, 21(1): 26-37.