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July 21, 2015

Notice Concerning Announcement of Results of Phase 3 Clinical Trials of TT-063 Anti-inflammatory Analgesic Patch Formulation Containing S-Flurbiprofen at the Annual Meeting of the Japanese Clinical Orthopaedic Association

Taisho Pharmaceutical Co., Ltd. (“Taisho Pharmaceutical”) [Head Office: Toshima-ku, Tokyo, President: Shigeru Uehara] announced two results of phase 3 clinical trials for the anti-inflammatory analgesic patch formulation containing S-flurbiprofen (Development Code: TT-063) at the Annual Meeting of the Japanese Clinical Orthopaedic Association held on July 19-20 in Shimonoseki City, Yamaguchi Prefecture. In October 2014, Taisho Pharmaceutical filed for manufacturing and marketing approval in Japan for TT-063 with planned application for osteoarthritis.

TT-063 was created by Taisho Pharmaceutical’s subsidiary TOKUHON Corporation (“TOKUHON”) [Head Office: Toshima-ku, Tokyo; President: Jun-ichi Fukudome], which Taisho Pharmaceutical subsequently joined to co-develop.

On July 20, Taisho Pharmaceutical announced two results of phase 3 clinical trials in Japan targeting patients with osteoarthritis at the Annual Meeting of the Japanese Clinical Orthopaedic Association, as follows:

1. The clinical trials investigated the efficacy of applying TT-063 for two weeks, targeting 633 patients with osteoarthritis of the knee joint. The patients were divided into a group of patients to whom TT-063 was administered, and a group of patients to whom a flurbiprofen gel patch (FP) was administered as a control drug. The trials compared the two groups.
The primary endpoint of the study was the change in the assessment of pain when standing (evaluation method: Visual Analogue Scale, “VAS”). The change in this pain assessment before and after application of the patch was 40.9 mm for the TT-063 group and 30.6 mm for the FP group. As a result, the TT-063 group demonstrated significantly superior efficacy relative to the FP group. In other areas, the TT-063 group demonstrated clinically higher efficacy in terms of the assessment of pain when walking (VAS) and clinical symptoms, compared with the FP group.

2. As a long-term trial, the clinical trials investigated the continuous application of TT-063 for 52 weeks, targeting 201 patients with osteoarthritis. The trials showed that 80% of the patients were able to continuously apply TT-063 over the trial period. Therefore, TT-063 was confirmed to possess good tolerability even during long-term use.

Osteoarthritis is a chronic degenerative disease of the joints, mainly involving degeneration and abrasion of joint cartilage. It is classified into osteoarthritis of the knee joint, lumbar spondylosis and other conditions depending on the affected area. The number of patients in Japan is estimated to be 24 million for osteoarthritis of the knee joint and 35 million for lumbar spondylosis, with approximately 30% of these patients showing symptoms of pain. Considering that pain is a major cause of a reduced quality of life (QOL), there are high hopes for the development of drugs that possess a powerful analgesic action.