SOURCE: Aoxing Pharmaceutical

December 06, 2010 08:30 ET

Aoxing Pharmaceutical Company Initiates Registration Clinical Trial of Buprenorphine / Naloxone Sublingual Tablets for Opioid Addiction Treatment

NEW YORK, NY--(Marketwire - December 6, 2010) -  Aoxing Pharmaceutical (NYSE Amex: AXN) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced initiation of the registration clinical trial of Buprenorphine/Naloxone sublingual tablets, indicated for opioid addiction treatment. 

The registration trial, approved by the SFDA, will be administered by the National Institute of Drug Dependence in China at Beijing University, the co-development partner for Aoxing Pharma. Patient enrollment will be led by four leading hospitals in drug addiction treatment in China. The trial is designed to establish the safety and efficacy of the Buprenorphine/Naloxone sublingual tablet therapy among patients who are suffering from opioid dependence.

"The initiation of this clinical trial is another significant clinical accomplishment for Aoxing and marks the beginning of a new chapter in medical therapies for Chinese opioid dependent patients who currently have no treatment options," said Zhenjiang Yue, Chairman and CEO of Aoxing Pharma. "We look forward to completing clinical trials by year end 2012 and believe that this drug could become an important therapeutic option for millions of patients and families in China who suffer painful drug dependence and its associated problems." 

The trial is a multi-center, randomized, single-blind and active-control study, which is planned to enroll approximately 240 patients registered at Drug Dependence Treatment Clinics or Centers. Subjects are randomized during a brief induction phase, a multi-week maintenance phase and a detoxification phase. 

About Buprenorphine/Naloxone Sublingual Tablets

Buprenorphine/Naloxone sublingual tablets are a combo formulation of buprenorphine HCl and naloxone HCl dihydrate. Total sales of the branded Buprenorphine/Naloxone sublingual tablets reached $900 million USD in 2009, sold by a global group of pharmaceutical companies in the US, France and many other countries. There is no domestic manufacturer for this product in China right now.

The tablets are typically taken once daily and are prescribed to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists, and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone prevent withdrawal symptoms when someone stops taking opioid drugs by producing effects similar to those produced by the opioids.

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 (SFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. It also has strategic alliance partnerships with QRxPharma, Phoenix PharmaLabs, Inc. and American Oriental Bioengineering, Inc. For more information, please visit: www.aoxingpharma.com.

Safe Harbor Statement from Aoxing Pharmaceutical Company, Inc.

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. The economic, competitive, governmental, technological and other risk factors identified in the Company's filings with the Securities and Exchange Commission, including the Form 10-K for the year ended June 30, 2010, 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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