Tokyo, Japan, June 20, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin" ) announced today that Hisamitsu Pharmaceutical Co., Inc. (Tosu, Saga, President and CEO: Hirotaka Nakatomi, "Hisamitsu Pharmaceutical") obtained an approval for additional indication of chronic pain* for Fentos® Tape (development code: HFT-290, "Fentos® Tape"), a Transdermal Long-Acting Pain Relief Patch on June 20, 2014.
Fentos® 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.
On July 2013, Hisamitsu Pharmaceutical made the application seeking approval based on the results of domestic clinical trials of the drug, which demonstrated its efficacy and safety for patients with moderate-to-severe chronic pain.
Kyowa Hakko Kirin will continue to market Fentos® Tape jointly with Hisamitsu Pharmaceutical. Through providing appropriate information of the product, the company hopes that the drug will contribute to improve quality of life in patients suffering from cancer pain and chronic pain.
In the International Association for the Study of Pain, chronic pain is defined as pain without apparent biological value that has persisted beyond the normal tissue healing time (usually taken to be three months).