Aoxing Pharma Announces Positive Results of Registration Trial of Buprenorphine/Naloxone Sublingual Tablets as Treatment of Opioid Dependence
Aoxing Pharmaceutical Company, Inc. (NYSE MKT: AXN) today announced positive results of its Buprenorphine/Naloxone sublingual tablets as a treatment for opioid dependence. This was a registration clinical study evaluating the safety and efficacy of the sublingual tablets in order to gain the final production and marketing clearance by the China Food and Drug Administration (CFDA).
In this multi-center, placebo-controlled, double-blinded, randomized, and paralleled study, 300 patients with opioid dependence were enrolled in 12-week therapy. The primary endpoints of this study were to evaluate the safety and effectiveness of the sublingual tablets for the opioid dependence patients, by measuring the rate of outpatient service. The secondary endpoints of the study included the negative rate of urine morphine test, and others. In the study, the drug demonstrated statistical significance in the measurements designed in the trial.
"We are very excited and encouraged by the progress of our Buprenorphine/Naloxone sublingual tablets program, which could be the first such therapy available in Chinese market for treating opioid dependence patients. We are working on the final preparation of the registration data package, and look forward to final clearance by the China CFDA," said Mr. Zhenjiang Yue, the Chairman and CEO of Aoxing Pharma.
Drug abuse has become a profound social problem in China. In 2014 it was estimated that there were 14 million individuals, or 1% of the whole population, with drug abuse or opioid dependence problems. The annual economic loss was estimated at approximately $100 billion USD due to drug abuse problem in China. At present, Methadone is the principal method of treating opioid dependence in China. Industry research has indicated at Buprenorphine/Naloxone is more effective than Methadone and significantly less injurious to the patient's overall health. For this reason, the Company believes that the product will find a large market when finally introduced in China.
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