Launch of Regtect® Tablets 333mg, the first approved drug in Japan for support maintenance of abstinence in patients with alcohol dependence
Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan, President: Shigenobu Maekawa) today announced the launch of “Regtect® Tablets 333mg” (Generic name: Acamprosate calcium) for support maintenance of abstinence in patients with alcohol dependence.
Alcohol dependence is a clinical condition in which a patient is unable to control drinking behaviors due to addictive alcohol intake. Regardless of gender, age or occupation, anyone who drinks alcohol has a possibility of suffering alcohol dependence. Patients with alcohol dependence have the strong and irresistible craving for alcohol, which cause pathological alcohol intake such as addictive drinking.
The final therapeutic goal for alcohol dependence is that the patient overcomes alcohol-dependent life>
“Regtect® Tablets 333mg” affects central nerve system and inhibits the hyperactivity of glutamatergic nerve system induced by alcohol dependence, and such novel mode of action is thought to contribute to reduce craving for alcohol. According to the results of clinical studies conducted in Japan, Regtect® showed significant improvement on success rate of abstinence (complete abstinence rate at the end of 24-week administration period) than placebo, when used as combinational drug with psychosocial treatment including psychotherapy such as counseling or joining self-help group.
Even though Regtect® has been marketed in 24 countries all over the world, including EU and US, it was unapproved in Japan. Therefore, Regtect® was designated as unapproved drugs with high medical needs by Ministry of Health, Labor and Welfare in May 2010 and Nippon Shinyaku was requested to develop it.
By the launch of Regtect® and providing a novel treatment option for alcohol dependence in Japan, Nippon Shinyaku expects to contribute to the patients who desire to recover from the disease, their family and medical specialists.
[Brand name] Regtect® Tablets 333mg
[Manufactured and distributed by] Nippon Shinyaku Co., Ltd.
[Approval number] 22500AMX00874000
[Composition] 333mg of acamprosate calcium is contained in a tablet.
[Generic name] Acamprosate calcium
[Indication] Support maintenance of abstinence in patients with alcohol dependence.
[Dosage and administration] Generally, for adult patients, 666 mg of acamprosate calcium at a time, three times a day, is orally administered after meal.
[Approval date] March 25, 2013
[NHI price listing date] May 24, 2013
[NHI price] 50.10Yen / tablet
[Package] Bottle of 500 tablets, PTP 100 tablets, PTP 500 tablets