The company currently manufactures and markets the oral capsule in China under the Cease Enuresis oral capsule brand, which was approved by China’s State Food and Drug Administration in 2002.
The FDA accepted the company’s investigational new drug for AOBO-001 in late 2008. The US Phase I clinical trial will commence shortly in order to evaluate the safety of AOBO- 001 in American populations. During the development of AOBO-001 in the US, various preclinical and clinical studies also will be conducted in China or other regions in order to expedite the development process, and all studies will be subject to relevant FDA regulations.
Tony Liu, chairman and CEO of American Oriental Bioengineering, said: “This is an important milestone in our product development initiatives. We believe that AOBO-001 is one of the herbal drug candidates with great development potential according to the guidance for industry, botanical drug products issued by the FDA in 2004, and we are particularly excited about the market opportunity for AOBO-001 in the US.”