Embera NeuroTherapeutics has released the results from a preclinical study of the combination use of metyrapone and oxazepam to treat nicotine addiction. Metyrapone and oxazepam, both of which are FDA-approved drugs, comprise EMB-001, Embera's lead pipeline candidate. Researchers found that at the lowest doses tested, the combination more effectively reduced nicotine intake than did either drug alone.
Results for the moderate dose level of EMB-001 were similar to those observed for the positive control varenicline, an FDA-approved smoking cessation product. In addition, EMB-001 demonstrated a dose response, and efficacy at the highest dose was greater than that of varenicline. The study, which published online on March 15, 2012 in the journal Psychopharmacology, was authored by Nicholas E. Goeders, Ph.D., Chief Scientific Officer of Embera and colleagues; Louisiana State University (LSU) Health Shreveport; Behavioral Pharma Inc; and The Scripps Research Institute.
"The data continue to suggest the potential efficacy of EMB-001 in treating stress-related addiction disorders, such as nicotine and cocaine dependence, and support further study of EMB-001 in our Phase 1 clinical trial, planned for 2013," said Bob Linke, Chief Executive Officer of Embera. "In a pilot clinical study published online in the January 2012 issue of the Journal of Psychopharmacology, the Embera team showed that EMB-001 was well tolerated and reduced cocaine usage and craving in cocaine-dependent subjects. This finding supports the further clinical testing of EMB-001 in cocaine dependence and other clinical indications, such as nicotine dependence."
"In the preclinical study, we not only established that the drug combination reduced nicotine intake, but also that the combination did not otherwise affect behavior," said Dr. Goeders, who is the lead author of the study. Dr. Goeders is also Professor and Head of the Department of Pharmacology, Toxicology & Neuroscience at LSU Health Shreveport. "The observation of effectiveness at the lowest combination doses tested in our models shows immense promise for patients suffering from addiction."