China-based pharmaceutical company American Oriental Bioengineering has said that it is initiating a phase one clinical trial of AOBO-001, an oral capsule developed from traditional Chinese herbal medicine for the treatment of urinary incontinence in the United States.

The company said that it 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 (SFDA) in 2002.

The company said that the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) for AOBO-001 in late 2008. The U.S. clinical trial phase one will commence shortly in order to evaluate the safety of AOBO- 001 in American populations.

During the development of AOBO-001 in the U.S., 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 U.S. FDA regulations.

Mr Tony Liu, Chairman and CEO of American Oriental, sad: “This is an important milestone in our product development initiatives. We have observed the efficacy of AOBO-001 on urinary incontinence in Chinese populations since 2002 when we launched Cease Enuresis Oral Capsules in China. We are optimistic that we can navigate the U.S. FDA approval process in a time and cost efficient way.”