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Introduction: Allergic rhinitis (AR) is one of the most common chronic conditions affecting both children and adults. The house dust mites (HDM) account for a substantial part of the overall sources of allergens. In patients where allergen avoidance and symptom-relieving pharmacotherapy do not provide adequate disease control, specific allergen immunotherapy (AIT) is indicated. While subcutaneous injection (SCIT) is considered as a time-consuming and invasive treatment regimen, sublingual allergy immunotherapy (SLIT) appears as more convenient treatment strategy. Areas covered: This Drug Profile reviews the clinical data behind the development of the SQ HDM SLIT-tablet, including both the early studies and the pivotal studies, which formed the basis for regulatory approval in Europe, Japan, and the U.S. Expert opinion: The clinical trials behind the development of the SQ HDM-SLIT have demonstrated that the tablet provides a safe, well-tolerated and robust efficacy in the treatment of HDM-induced allergic rhinoconjunctivitis. Further, studies show that the SQ HDM SLIT-tablet is a cost-effective treatment option compared with SCIT. [ABSTRACT FROM AUTHOR]

This open-label, nonrandomized study assessed single and repeat ascending doses of a new sublingual fentanyl (SLF) formulation in 48 healthy Japanese opiate-naïve subjects (47 completed). Subjects received single-dose SLF 100, 200, 400, or 800 µg followed by 13 doses 6 hourly, at their dose level. Subjects taking repeat-dose 400 and 800 µg were pretreated with naltrexone in order to block opiate-receptor–mediated effects on respiration, monitored by pulse oximetry and transcutaneous pco2. Sublingual fentanyl was rapidly and consistently absorbed. After single doses, median tfirst was 0.08 to 0.25 hours and tmax 0.50 to 1.00 hours. After repeat dosing, median tmax (tmax,ss) was 0.50 to 2.00 hours. Plasma concentrations were dose proportional both after single and repeat dosing, and naltrexone appeared to have no effect on SLF pharmacokinetics. Plasma fentanyl reached steady state within the 72-hour dosing period and accumulation was approximately 2-fold. After single doses, effects on respiratory variables were evident after the 400-µg and 800-µg doses. Transcutaneous pco2 was not helpful in detecting respiratory depression. Thus, SLF yielded rapid absorption of fentanyl and dose-proportional plasma concentrations that, for 400 µg and 800 µg, were within the typical analgesic range. Respiratory depression in these opioid-naïve volunteers was manageable with simple clinical measures. [ABSTRACT FROM PUBLISHER]