Embera NeuroTherapeutics, Inc. and Collaborators Publish Paper in Psychopharmacology Supporting its Novel Drug Combination, EMB-001, for Smoking Cessation

BOSTON & SHREVEPORT, La.--(BUSINESS WIRE)--Embera NeuroTherapeutics Inc., a specialty pharmaceutical company developing novel treatments for smoking cessation and other addictions, announced today the publication of 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.”

About EMB-001

EMB-001 is a novel addiction treatment that acts by uniquely modulating multiple stress-related pathways to address the cravings that drive addiction. EMB-001 acts by mechanisms distinct from those of existing addiction treatments, and is based on the contribution of stress and the hypothalamic-pituitary-adrenal (HPA) axis to the acquisition and maintenance of addiction. This treatment comprises two FDA-approved medications, the benzodiazepine oxazepam and the cortisol synthesis inhibitor metyrapone. This patent-pending combination is based on a discovery made by the company’s scientific founder, Dr. Nicholas Goeders at LSU Health Shreveport, on the role of physiologic responses to chronic stress in addiction.

About Embera NeuroTherapeutics

Embera NeuroTherapeutics, Inc. is a development-stage pharmaceutical company focused on treating a broad range of addictions where the major clinical challenge is a limited range of effective drug therapies. Embera is developing a novel drug combination (EMB-001) targeting specific brain functions related to stress response that drive craving and relapse associated with these disorders. Embera is advancing EMB-001 development programs in smoking cessation and cocaine dependence. Embera is supported by Louisiana Fund I and BVM Capital.

For additional information about the company, please visit www.emberaneuro.com.

Contacts

Embera NeuroTherapeutics, Inc.:

Bob Linke, 617-719-9406

President and CEO

rlinke@emberaneuro.com

or

Media:

MacDougall Biomedical Communications

Jennifer Conrad, 781-235-3060

jconrad@macbiocom.com