Serotonin-agonist antianxiety drug Sediel approved for sale in China
Sumitomo Pharmaceuticals, Co., Ltd. has been working in the People's Republic of China to develop serotonin-agonist antianxiety drug Sediel (generic name: tandospirone citrate, marketed as Sediel in Japan), and is now able to announce receipt of approval from the State Food and Drug Administration of the People's Republic of China on June 9. (Permit for import and sale issued on May 21.) The drug will be marketed under the name "Sediel" ("Xide") and is recognized to be effective for conditions including generalized anxiety disorder. Training for medical representatives on this and other preparations for sale are now in progress, and plans are for a full-scale sales setup to be put in place by the start of 2004.
Sediel is a new type of antianxiety drug developed independently by Sumitomo Pharmaceuticals, and is different from the benzodiazepines. It acts selectively on only the serotonin nerves in the brain that play an important part in the formation of anxiety and depression, and demonstrates antianxiety and anti-depression effects. Since it does not act on the other nerves that are so extensive in the brain, there is virtually no hypnotic or sedative effect, and the drug displays virtually no drug-dependence or side effects such as drowsiness and dizziness. Sediel has been on sale in Japan since December 1996, and is recognized for its effectiveness in treating psychosomatic and neurotic disorders.
The Chinese authorities have approved Sediel for treatment of generalized anxiety disorder (GAD). GAD is considered by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), to be a form of anxiety disorder characterized by "excessive anxiety and worry (apprehensive expectation) occurring for longer than at least 6 months." Symptoms caused by the disorder continue for long periods, with repeated cycles of improvement and relapse.
As China modernizes, stress is reported to be taking a hold on society in the same way as it did in Japan, so as an antianxiety drug with little adverse impact on day to day living, Sediel can also make a useful contribution in China.
Sumitomo Pharmaceuticals has a record of marketing products in China, starting with Almarl (marketed under the same name in Japan), a therapeutic agent for hypertension, angina pectoris, arrhythmia and essential tremor in 1996, followed by Cefpiran (Sepatren in Japan), a cephalosporin antibiotic, and Mepem (Meropen in Japan), a carbapenem antibiotic. The company maintains its own promotion setup in the PRC, having opened an office in Beijing in 1997 and a second office in Shanghai in 2000, and will continue to actively promote the sale of products of our origin in the Chinese market.