Press Releases / Notices

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NEWS 2012

September 19, 2012 Pharmaceuticals

New Drug Application of

Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) announced that it has submitted a New Drug Application (NDA) of “Tramal® Capsule 25mg” and “Tramal® Capsule 50mg”(generic name: tramadol hydrochloride) for the treatment of chronic pain today.

“Tramal® Capsule” is a nonnarcotic opioid analgesic which acts as μ-opioid receptor agonist and monoaminergic action (reuptake inhibition of noradrenalin and serotonin), and has been launched as the treatment of mild to moderate cancer pain since September 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 for an indication extension in 2009.

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.

The daily dosage can be adjusted from 100mg to 300mg (Maximum 400mg daily) according to the symptoms with 2 kinds of strengths (25mg and 50mg).

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.

[For your reference] Tramal® Capsule
Brand name: “Tramal® Capsule 25mg”, “Tramal® Capsule 50mg”
Generic name: Tramadol hydrochloride
Indication: mild to moderate cancer pain
Manufactured and distributed by: Nippon Shinyaku Co., Ltd.
NHI price: 37.50Yen / 25mg capsule, 65.90Yen / 50mg capsule
Release date: September, 2010