2, indications: schizophrenia
3. Status: clinical approval was obtained on July 1 1 2005 (approval number: 2005L02339); Pass SFDA audit
4. Approved category: chemical medicine 3. 1.
5. Features: Atypical antipsychotics in China are blank.
6. Transfer quotation: 500,000 yuan.
7, the purpose of the topic and product characteristics.
Schizophrenia is a group of diseases with unknown etiology, which occupies an extremely important position in psychiatry because of its high incidence. At present, the treatment of schizophrenia mainly depends on drug treatment. According to the clinical characteristics of antipsychotic drugs, they can be divided into typical and atypical drugs. At present, atypical antipsychotics in the domestic market are all imported from abroad, and the prices are relatively high.
The treatment of schizophrenia is a long-term task. Patients need to take medicine for a long time, and some patients need to take medicine for life. Therefore, anti-schizophrenia drugs should not only be effective, but also have fewer side effects. At present, domestic antipsychotic drugs are typical antipsychotic drugs, which have serious side effects during long-term use, which often leads to patients' inability to persist in long-term use. Atypical antipsychotic drugs have good curative effect and few side effects, which represents the development direction of schizophrenia drugs.
Peropirone hydrochloride is an atypical antipsychotic, and its main pharmacological mechanism is to antagonize 5-HT and dopamine D2 receptors. Studies have shown that peropirone is effective in the treatment of various problem behaviors caused by excessive activity of dopaminergic nervous system, and can significantly improve the negative symptoms and emotional disorders caused by the ineffectiveness of traditional antipsychotics. Clinical double-blind trial shows that the improvement of positive symptoms of schizophrenia by peropirone is equivalent to that of droperidol, but the negative symptoms are obviously better than that of droperidol, and the extrapyramidal side effects are lower than that of droperidol. Therefore, as an antagonist of 5-HT and D2 receptors, peropirone has a wide range of clinical effects, low extrapyramidal adverse reactions and a slight increase in prolactin.
At present, it is estimated that there are 8 million schizophrenics in China, but there are few kinds of antipsychotics on the domestic market. At present, classic antipsychotics such as haloperidol and 5- fudol are still widely used. Clozapine is the most widely used atypical antipsychotic drugs with better efficacy, but it can lead to severe agranulocytosis, lower seizure threshold and salivation. At present, the sales volume of clozapine in China has become the first among antipsychotics, indicating that atypical antipsychotics have become the mainstream. As a new atypical antipsychotic drug, peropirone hydrochloride has higher efficacy and safety than traditional antipsychotics. By antagonizing 5-HT and D2 receptors, the positive and negative symptoms of schizophrenia can be alleviated, and the spectrum of action is wider. Another feature is better tolerance and compliance, and small oral dose. The recommended initial dose is 4mg tid and the maximum dose is 48mg/ day. The treatment cost is low. The price of 4mg tablets in Japan is 27 yen/tablet, which is about equal to 2 yuan RMB. It has an ideal curative effect/price ratio and will have a strong market competitiveness in antipsychotics. Therefore, peropirone hydrochloride is expected to replace clozapine after it is listed in China.
8. The research survey and clinical application of this product at home and abroad.
Peropirone hydrochloride was developed by Sumitomo Pharmaceutical Co., Ltd. (now merged with Dainippon Pharmaceutical Co., Ltd.) and was approved to be listed in Japan in February, 20001year, with the trade name of "Lulan tablets, ルーランンン ingots". At present, the annual sales are about10 billion yen (. This product has not applied for patent and administrative protection in China, so there is no intellectual property problem in developing this product.
At present, there are 1 manufacturers in China, and 5-6 are in the clinical research stage.