CardiovascularChina Aoxing Pharmaceutical Company Acquires A Novel Menstrual Pain Drug
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a pharmaceutical company specializing in research, development, manufacturing and marketing of narcotic and pain-management products, announced that it has acquired all rights to TJSL, a novel drug at Phase II development stage to treat primary dysmenorrhea ("PD"), or menstrual pain, in adult women.
The prevalence rates of PD among women are from 60 to 90 percent. It is estimated that 64% of women in China purchase menstrual pain drugs on regular basis. The market size of healthcare product to address menstrual pain is estimated at $3 billion per year in China.
TJSL is a capsule form of selected herbal medicines at Phase II clinical development under the protocol approved by the China State Food and Drug Administration ("SFDA"). The mechanism of action of the drug deserves further investigation, but appears to be its capability of reversing the effects of endometrial prostaglandin, reducing the frequency and strength of uterine contraction as well as providing pain relief, based on in vivo study.
The ongoing Phase II clinical study is a multi-center, randomized, double-blind and placebo-controlled trial of over 200 female patients under three month oral therapy at four academic hospitals in China. The endpoint of the studies is the drug"s efficacy and safety, including improvement of abdominal pain during menstruation, measured by visual analogue scale ("VAS"). The study has progressed well and already moved into post-treatment observation stage for its enrolled patients between 18 and 35 years old. The Phase II clinical study is expected to be completed in second half of 2009.
"China Aoxing has made the strategic decision to expand our commitment within the field of pain management," stated Juan Yue Han, Chairman and the CEO of China Aoxing. "The acquisition of TJSL product significantly enhances our profile within the women health community while enabling us to serve yet another greatly underserved market segment in pain management."
"Based on the progress and results to date, TJSL appears to be very promising for routine treatment of PD. A large body of evidence has indicated the drug"s efficacy and safety empirically collected from the treatment of over 800 patients who suffered from PD. We look forward to additional supporting data from the ongoing trial with over 200 patients, which we believe to be the most comprehensive and robust Phase II study for PD indication in China," commented Ms. Liying Yang, the Vice President of Research & Development in China Aoxing.
About Primary Dysmenorrhea ("PD")
Primary dysmenorrhea is defined as recurrent, cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of demonstrable pelvic disease, such as endometriosis. Prevalence rates are as high as 90 percent. Initial presentation of PD typically occurs in adolescence. It is a common cause of absenteeism and reduced quality of life in women. Women with PD have increased production of endometrial prostaglandin, resulting in increased uterine tone and stronger, more frequent uterine contractions.
Pharmacological interventions available in the market include non-steroidal anti-inflammatory drugs (NSAIDs), hormomal contraceptives, levonorgestrel intrauterine contraception and tocolytics.
About TJSL Capsules
TJSL was originated by Professor X. Tian, a well-known gynecologist in China. The drug is composed of several herbal medicines optimized based on her 40 years of medical research in treating PD. The drug has been used empirically by over 800 patients who suffered from PD. From in vivo studies, the drug was capable of reversing the effects of endometrial prostaglandin, reducing the frequency and strength of uterine contraction as well as providing pain relief.
China Aoxing Pharmaceutical Company, Inc.