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September 14, 2012
| Torii Pharmaceutical Co., Ltd. |
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| Top-line Results of Phase III Clinical Study of TO-194SL, a Sublingual Immunotherapy Drug for Cedar Pollinosis, in Japan |
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Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) has announced the top-line results of Phase III clinical study, study number 194-3-1, of TO-194SL, a sublingual immunotherapy drug for Japanese cedar pollinosis.
This is a randomized, placebo-controlled, double-blind, parallel-comparison study to evaluate the efficacy and safety of TO-194SL in patients with Japanese cedar pollinosis.
In the top-line results, the study demonstrated the drug was statistically superior to placebo, in lowering the "overall nasal symptom and medication score" at the end of treatment (primary efficacy endpoint).
Furthermore, this study demonstrated no specific clinically significant findings on safety and tolerability of TO-194SL within the treatment period.
Torii will conduct the full-analysis of the study results and aim to submit a New Drug Application in Japan in the fiscal year ending March 31, 2013.
About Cedar pollinosis
Japanese Cedar pollinosis collectively refers to an allergic disease caused by Japanese cedar pollen. Patients with cedar pollinosis have excessive immunological reaction to pollens and develop sneezing, nasal discharge, nasal occlusion, itchiness of the eyes, and runny eyes among other symptoms.
According to a nationwide survey, about 20% of Japanese people have pollinosis and about 70% of them have cedar pollinosis.
(A FY 2010 MHLW-subsidized research program for prophylaxis/treatment of immunological allergic diseases, "Research for Correct Treatment of Pollinosis")
About Sublingual immunotherapy
During sublingual immunotherapy, the causative allergen is sublingually administered at a concentration/dose which is low at first and is increased gradually.
When it reaches to a maximum level, the concentration/dose is administered daily as the maintenance dose to attenuate hypersensitivity to the allergen. Some foreign clinical reports show that sublingual immunotherapy achieves long term remission of allergic diseases.
Although injectable preparation used for immunotherapy is already approved in Japan, it is not popular enough because of concerns about the risk of rare but severe allergic reactions, the pain patients suffer from after a subcutaneous injection.
TO-194SL, which is administered sublingually not by injection, can relieve patients from the pain associated with subcutaneous injections and give them advantages of convenient administration.
About Overall nasal symptom drug score
The overall nasal symptom and medication score is a total overall score of nasal symptom (sum of the scores allocated as appropriate, depending on the severity of three symptoms, sneeze, nasal discharge, and nasal occlusion) and the medication score (sum of the scores allocated as appropriate, depending on the antihistaminic dose, etc. used to alleviate cedar pollinosis symptoms). Variable methods are used to measure the degree of alleviation of rhinitis and other allergic symptoms.
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