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Friday, March 15, 2013
Kyowa Hakko Kirin announces Phase 3 results from a Japanese Phase 3 Clinical Trial on the Additional Indication of Chronic Pain for Fentos Tape, a Transdermal Long-Acting Cancer Pain Relief Patch
Kyowa Hakko Kirin Co., Ltd. announced that the Company was informed on March 8, 2013 by Hisamitsu Pharmaceutical Co., Inc. that results had been announced externally from a Japanese phase 3 clinical trial on the additional indication of chronic pain
Tape, a transdermal long-acting cancer pain relief patch.
Tape is a narcotic ethical (Rx) pharmaceutical product developed as a transdermal patch of fentanyl citrate, a synthetic narcotic that exhibits significant analgesic effects, using Hisamitsu Pharmaceutical's transdermal drug delivery system (TDDS). Kyowa Hakko Kirin and Hisamitsu Pharmaceutical have been collaborating on the distribution of this product and the provision and collection of information (one brand, two channels) since June 2010.
The Japanese phase 3 clinical trial was a randomized, double-blind study on the efficacy of once daily use of Fentos
Tape for the additional indication of chronic pain. The results showed that Fentos
Tape was effective for patients with moderate-to-severe chronic pain. Hisamitsu Pharmaceutical aims to file for approval of chronic pain as an additional indication for Fentos
Tape during 2013.
Kyowa Hakko Kirin will continue to market Fentos
Tape jointly with Hisamitsu Pharmaceutical. The companies hope that approval of the additional indication of chronic pain will contribute to improved quality of life in patients suffering from chronic pain.
Chronic pain is persistent pain that prevent patients from performing daily activities. Causes include chronic disorders(eg, cancer, arthritis) and low back pain.
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