Translation
Nov 28, 2008
| Maruho Co., Ltd. Chugai Pharmaceutical Co., Ltd. |
Maruho Co., Ltd. [Head Office, Kita-ku, Osaka; President, Koichi Takagi] (hereafter, "Maruho") and Chugai Pharmaceutical Co., Ltd. [Head Office, Chuo-ku, Tokyo; President, Osamu Nagayama] (hereafter, "Chugai") are pleased to announce that the Ministry of Health, Labour and Welfare approved a new indication for Oxarol® Ointment 25mcg/g (hereafter, "Ointment") and Oxarol® Lotion 25mcg/g (hereafter, "Lotion"), treatment drugs for keratosis including psoriasis vulgaris, for extended treatment of palmoplantar pustulosis as of November 25, 2008. Chugai has the marketing approval and Maruho distributes for the products.
Maxacalcitol, an active ingredient of the drugs, is an active vitamin D3 derivative developed by Chugai. It inhibits proliferation and induces differentiation of epidermal keratinocytes.
Since market launch of "Ointment" in October 2001, it has been widely used in patients with keratosis including psoriasis vulgaris, remarkably improving the symptoms.
"Lotion" was launched in June 2007. It has been improved so that patients can easily apply the product to hairy areas such as head, a common site of psoriasis vulgaris.
The efficacy and safety of the drugs for palmoplantar pustulosis were demonstrated in the clinical trials conducted in applying for approval for extended indication.
Currently, steroids are mainly used for topical treatment of palmoplantar pustulosis. However, since low-concentration tacalcitol is the only active vitamin D3 derivative that is indicated for palmoplantar pustulosis, the additional indication of topical treatment Oxarol® for palmoplantar pustulosis is expected to provide more treatment choices to patients with palmoplantar pustulosis.
[Reference]
<Product Summary>
| Product Name | Oxarol® Ointment Oxarol® Lotion |
| Nonproprietary Name | Maxacalcitol |
| Composition | One gram of Oxarol® product contains 25mcg of maxacalcitol |
| Indications | Psoriasis vulgaris, ichthyosis, palmoplantar keratosis, palmoplantar pustulosis |
| Dosage and Administration | Appropriate amount of Oxarol® product should be applied to the affected area twice daily. Depending on the symptom, application frequency should be decreased as necessary. |
| Precaution concerning Dosage and Administration | The maximum recommended daily dose of maxacalcitol is 250mcg, or 10g of topical maxacalcitol. |
| Package | Ointment: tube 10g x 1, 10g x 10 Lotion: bottle 10g x 1, 10g x 10 |
| Marketing authorization holder | Chugai Pharmaceutical Co., Ltd. |
| Drug Price | 138.40 yen per 1g |
<Palmoplantar Pustulosis>
Palmoplantar pustulosis is a chronic skin disease characterized mainly by symmetrical distribution of sterile pustules on the palms and soles, and the cause of the pathogenesis is currently not understood. It has been reported that the onset reaches a peak in the age of 40 to 49 years both in men and women and the ratio of women to men tends to increase in the ages of 50 years and older.
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