Aoxing Pharmaceutical Company, Inc. /quotes/comstock/14*!axn/quotes/nls/axn (AXN 2.33, -0.05, -2.10%) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced that the China SFDA has granted approval of the company's New Drug Application to initiate the registration clinical trial of Buprenorphine/Naloxone sublingual tablets for opioid addiction treatment. The approval enables Aoxing Pharma to move forward to the final development stage with this therapy, which is novel in China as it is not yet available to patients.
The registration trial will be administered by the National Institute on Drug Dependence of China at Beijing University, the co-development partner of Aoxing Pharma. The patient enrollment will take place in at least three Compulsory Drug Dependence Treatment Centers. 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.
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