Embera's Combination Treatment: EMB-001
EMB-001 is a novel addiction treatment that acts by uniquely modulating multiple stress-related pathways to address the craving that drives addiction and to maximize potential efficacy. EMB-001 acts by mechanisms distinct from those of existing addiction treatments, and is based on the contribution of the body's stress response to the acquisition and maintenance of addiction. This patent-pending treatment comprises two FDA-approved medications, the benzodiazepine oxazepam and the cortisol synthesis inhibitor metyrapone, a combination that is based on discoveries made by the company's scientific founder Dr. Nicholas Goeders' work on the role of physiologic responses to chronic stress in addiction.
EMB-001 may substantially reduce craving and loss of control, potentially resulting in long term abstinence from smoking and drug use. Therapies that break these barriers to recovery would be significant contributions to the treatment of a broad range of addictions.
Clinical Development
Embera has completed a randomized, double-blind, placebo-controlled pilot clinical study of EMB-001 in cocaine-dependent subjects. EMB-001 treatment resulted in significantly reduced cocaine use, compared to placebo, by the end of the study. Additionally, treatment with EMB-001 led to significant reductions in cocaine craving at several time points during the study, and was well tolerated over the 6-week treatment period.
The Company's clinical development program is supported by positive preclinical studies in which the EMB-001 combination reduced self-administration of nicotine, as well as cocaine and methamphetamine, in relevant models of addiction. In nicotine studies, EMB-001 demonstrated statistically significant performance versus the positive control, varenicline. Cocaine studies of EMB-001 established the drug combination's efficacy at doses which, when tested as monotherapy, had no effect. These results suggest that EMB-001 has the potential to break the barriers to addiction recovery.
Research and Information
Effects of the combination of metyrapone and oxazepam on cocaine and food self-administration in rats
Goeders NE, Guerin GF., Pharmacol Biochem Behav. 2008 Nov;91(1):181-9. Epub 2008 Jul 19
Stress, the hypothalamic-pituitary-adrenal axis, and vulnerability to drug abuse. (Please contact Embera for a copy of this article)
Goeders NE, NIDA Res Monogr. 1998 Mar;169:83-104. Review. No abstract available. PMID: 9686412
Effects of surgical and pharmacological adrenalectomy on the initiation and maintenance of intravenous cocaine self-administration in rats.
Goeders NE, Guerin GF., Brain Res. 1996 May 25;722(1-2):145-52.
Stress and cocaine addiction.
Goeders NE,, J Pharmacol Exp Ther.2002 Jun;301(3):785-9. Review.PMID: 12023504
The HPA axis and cocaine reinforcement.
Goeders NE.,Psychoneuroendocrinology.2002 Jan-Feb;27(1-2):13-33. Review.PMID: 11750768
The impact of stress on addiction.
Goeders NE., Eur Neuropsychopharmacol.2003 Dec;13(6):435-41. Review. PMID: 14636959