Sublingual tablets

Allergen immunotherapy tablets have been at the centre of an unequalled clinical development plan in compliance with the new 2009 EMA (European Drug Agency) directives ^{1, 2} concerning:

-    the quality of products,
-    the methodology of clinical trials that document efficacy and safety of the product in adults and children.

Allergen immunotherapy tablets thus obtained European-wide registration as a pharmaceutical product. Offering unequalled levels of evidence based medicine to specialised physicians, these tablets also meet the requirements of patients in terms of practicality and easy administration. Thereby, galenic improvements have led to better treatment compliance which is vital to treatment efficacy.

Presently, allergen immunotherapy tablets are only available for the treatment of allergies to grass pollen. Other tablets are currently being developed (allergies to mites and birch pollen, etc.).

The treatment must be prescribed and initiated by a specialised physician trained and experienced in the treatment of allergic diseases.

Usual dosage is one tablet per day to be taken at home. The tablet must be kept under the tongue for at least 1 minute (until completely dissolved) and then swallowed.

Depending on available treatments various administration protocols exist for sublingual immunotherapy tablets:

• The pre- coseasonal protocol which starts every year approximately 4 months before the pollen season and is continued throughout the season (approximately 1 to 2 months depending on the country and regions) and then is stopped at the end of the season. The treatment will thus be repeated each year approximately 4 months before the pollen season in accordance with the same protocol.
• The perennial protocol can be started at any time (at least 4 months before the pollen season) and is administered continuously throughout the course of treatment.

In accordance with WHO³ recommendations the overall duration of sublingual allergenic immunotherapy treatment is 3 to 5 years or 3 to 5 consecutive seasons in the case of the pre- coseasonal protocol.

¹ EMA (European Medicines Agency). Committe for Medicinal Products for human use (CHMP). Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases. London, 20 November 2008. Doc. Ref. CHMP/EWP/18504/2006.
² EMA (European Medicines Agency). Committe for Medicinal Products for human use (CHMP). Guideline on allergen products standardization and quality issues London, 20 November 2008. Doc. Ref. CHMP/BWP/304831/2007
³ Bousquet J, Lockey RF, Malling HJ. et al. Allergy 1998; 53