IR News 2013


March 25, 2013 Pharmaceuticals

Nippon Shinyaku Co., Ltd, obtains approval for Regtect® Tablet 333mg for support maintenance of abstinence in patients with alcohol dependence

Nippon Shinyaku Co.,Ltd, (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) today announced that Regtect® Tablet 333mg (Code No.: NS-11, Generic name: Acamprosate calcium) has been granted marketing authorization by the Ministry of Health, Labor and Welfare (MHLW) of Japan for support maintenance of abstinence in patients with alcohol dependence. Regtect® was licensed-in from Merck Sante s.a.s.1 in 2003, and has been developed in Japan by Nippon Shinyaku since then.

Alcohol dependence is a clinical condition that patients are unable to control drinking behaviors due to addictive alcohol intake. Alcohol dependence is characterized by the strong and irresistible craving for alcohol, which causes psychological and physical disorders to the patients, and which also has serious influence on their family members followed by social issues. However, alcohol dependence is a disease that could recover if treated properly. For the recovering, it is very important for patients to receive treatment by experienced medical specialists.

Regtect® affects central nerve system and inhibits the hyperactivity of glutamatergic nerve system induced by alcohol dependence, and such mode of action is thought to contribute to reduce craving for alcohol. Regtect® has been marketed in 24 countries all over the world, including EU and US. In Japan, Regtect® was designated as unapproved drugs with high medical needs by MHLW in May 2010 and Nippon Shinyaku was requested to develop it.

According to results of clinical studies conducted in Japan, Regtect® shows 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.

Since no drug for the curative treatment is currently available in Japan, medical specialists as well as the patients have been longing for the development of a new drug over the years. By the launch of Regtect®, Nippon Shinyaku expects to contribute to the treatment of alcohol dependence in Japan.

[Brand name] Regtect® Tablet 333mg
[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

Upon drug price listing, Nippon Shinyaku is planning to launch Regtect® in Japan.

Merck Sante s.a.s. is a subsidiary of Merck KGaA, Darmstadt, Germany, operating within the Merck Serono division