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NEWS 2013

June 14, 2013 Pharmaceuticals

Nippon Shinyaku receives marketing authorization of "Tramal® Capsule 25mg" and "Tramal® Capsule 50mg" in Japan for the treatment of chronic pain as an indication extension

Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) today announced that it has received marketing authorization of “Tramal® Capsule 25mg” and “Tramal® Capsule 50mg” (generic name: tramadol hydrochloride) in Japan for the treatment of chronic pain as an indication extension.

Chronic pain is pain that has lasted for more than several months after the healing of illness or trauma or despite remission of physical abnormality and includes pain caused by refractory chronic diseases.

Tramal®, a central analgesic and licensed-in from Grunenthal GmbH (Germany), has been approved and launched in more than 100 countries in the world. In Japan, it has been launched as the treatment of mild to moderate cancer pain since 2010.

Since tramadol hydrochloride is widely distributed as the treatment of chronic pain as well as cancer pain in abroad, Nippon Shinyaku initiated clinical studies in 2009 for an indication extension in Japan.

By the indication extension of “Tramal® Capsule”, Nippon Shinyaku expects to contribute more to the QOL of the patients who are suffering from such chronic pain as well as cancer pain.

[About Tramal® Capsule]
Brand name: “Tramal® Capsule 25mg”, “Tramal® Capsule 50mg”
Generic name: Tramadol hydrochloride
Indication: Treatment of pain with following diseases in patients with insufficient pain relief with nonopioids.
  - Cancer pain in patients with various cancers
  - Chronic pain
Dosage: Generally, daily dose of 100-300 mg of tramadol hydrochloride should be administered orally, divided into 4 times a day, for adults.
Meanwhile, the dosage should be adjusted to the symptom and the sensitivity of the individual patient. However, a single dose of 100 mg and daily dose of 400 mg should not be exceeded.

NHI price: 37.50Yen / 25mg capsule, 65.90Yen / 50mg capsule
Release date: September, 2010