- Published: 13 July 2015
- Written by Editor
Aoxing Pharma Announces Positive Results of Registration Trial of Buprenorphine/Naloxone Sublingual Tablets as a Treatment of Opioid Dependence
JERSEY CITY, NJ / July 13, 2015 / Aoxing Pharmaceutical Company, Inc. (NYSE MKT: AXN) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing, and distribution of narcotic, pain-management and addiction treatment pharmaceuticals, 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.
About Aoxing Pharmaceutical Company, Inc.
Aoxing Pharmaceutical Company, Inc. is a US incorporated specialty pharmaceutical company with its operations in China, specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. Headquartered in Shijiazhuang City, outside Beijing, Aoxing has the largest and most advanced manufacturing facility in China for highly regulated narcotic medicines. Its facility is one of the few GMP facilities licensed for the manufacture of narcotic medicines by the China State Food and Drug Administration (CFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. For more information, please visit: www.aoxingpharma.com.
Safe Harbor Statement from Aoxing Pharmaceutical Company, Inc.
Certain statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. All forward-looking statements included herein are based upon information available to the Company as of the date hereof and, except as is expressly required by the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. To the extent that any statements made here are not historical, these statements are essentially forward-looking. Undue reliance should not be placed on forward-looking information. The economic, competitive, governmental, technological and other risk factors identified in the Company's filings with the Securities and Exchange Commission, specifically, Item 1A, "Risk Factors," in the Form 10-K for the year ended June 30, 2014, may cause actual results or events to differ materially from those described in the forward looking statements in this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.
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SOURCE: Aoxing Pharmaceutical Company, Inc.