Location: Product

EMB-001 - A Key to Treating Addiction?

The scientific foundation of Embera is based on the patented approach to stress and addiction developed by Dr. Nicholas Goeders. The initial product is the company's patent-pending drug combination of two off-patent, FDA approved drugs, called EMB-001. Embera believes that this technology may represent a breakthrough in the treatment of addictive and other stress-related psychiatric disorders in breaking the neural pathways related to cravings. This breakthrough technology may stop the cravings and urges related to the relapse to drug use rather than blocking or mimicking the effect of the abused drug, the approach most companies are taking.

The Technology Behind EMB-001

Insights into the understanding of drug abuse and addiction have revealed that the desire to use drugs and the process of addiction depends on the effect of the drug on brain function. There is overwhelming scientific evidence that most drugs, including cocaine, methamphetamine, heroin, ethanol, and nicotine, result in addiction.

Addictive drugs directly activate the Hypothalamo-Pituitary-Adrenal axis (HPA) and the sympathetic nervous system. The activation of the HPA axis causes the adrenal glands to produce a steroid chemical called cortisol (corticosterone), which is a stress hormone in humans that has many important functions in every organ system of the body. The activation of the HPA axis leads to biological changes such as an increase in heart rate and other signs of stimulation. Other psychiatric disorders have also been shown to either stimulate the HPA axis, with a resulting increase in circulating cortisol, or may otherwise alter the normal function of the HPA axis.

Most other medicines designed to treat drug and alcohol addictions typically only target the limbic system of the brain. The Company's approach however, targets the prefrontal cortex, which is a higher cognitive center than the limbic system. Embera's lead therapeutic patent-pending drug, EMB1001, developed by Dr. Goeders, is a novel composition of two off-patent, FDA-approved drugs. Both drugs, approved for other indications, have a long history of use with a well established safety profile. EMB001 is a specific combination of each drug at a concentration lower than the effective dose of either drug alone, further reducing safety concerns.

Market and Indications

Addiction continues to be a significant problem that plagues the United States and the rest of the world. The development of effective strategies for the prevention and treatment of addiction, including the use of medications, are, of paramount importance. As a result, over the past 30 years, neurobiologists have been decoding the brain's addiction pathways in an effort to develop medications that act on brain receptors located in these pathways to blunt cravings, ease withdrawal symptoms and dull the euphoric effects of drugs and alcohol. Despite this research, no medications have been developed that successfully prevent the cravings that produce drug and alcohol addiction.

Cocaine

In 2004, an estimated 1.6 million Americans could be classified as dependent on or abusing cocaine in the past 12 months, according to the National Survey on Drug Use and Health.

• Approximately 34.2 million Americans ages 12 and older had tried cocaine at least once in their lifetimes, representing 14.2% of the population ages 12 and older.
• Approximately 5.7 million (2.4%) has used cocaine in the past year.

Methamphetamine

According to the 2004 National Survey on Drug Use and Health, nearly 12 million Americans have tried methamphetamine. Methamphetamine abuse, long reported as the dominant drug problem in the California area, has become a substantial drug problem in other sections of the West and Southwest, as well. There are indications that it is spreading to other areas of the country, including both rural and urban sections of the South and Midwest. Methamphetamine, traditionally associated with white, male, blue-collar workers, is being used by more diverse population groups that change over time and differ by geographic area.

Alcohol

The National Institute on Drug Abuse's latest research report on alcohol abuse finds that 50% of the adult U.S. population (aged 18 and over) are current drinkers who have consumed at least 12 drinks in the preceding year. Although most people who drink do so safely, the minority who consume alcohol heavily produce an impact that ripples outward to encompass their families, friends, and communities.

• More than one fifth (22.8 percent) of persons aged 12 or older participated in binge drinking at least once in the 30 days prior to the survey in 2004. This translates to about 55 million people, comparable with the 2002 and 2003 estimates.
• In 2004, heavy drinking was reported by 6.9 percent of the population aged 12 or older, or 16.7 million people. These figures are similar to those of 2002 and 2003, when 6.7 and 6.8 percent, respectively, reported heavy drinking.

Anxiety Disorders

Anxiety disorders include panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and phobias (social phobia, agoraphobia, and specific phobia).

• Approximately 40 million American adults ages 18 and older, or about 18.1 percent of people in this age group in a given year, have an anxiety disorder.1
• Anxiety disorders frequently co-occur with depressive disorders or substance abuse.1
• Most people with one anxiety disorder also have another anxiety disorder. Nearly three-quarters of those with an anxiety disorder will have their first episode by age 21.5

Research and Information

Stress, the Hypothalamic- Pituitary- Adrenal Axis, and Vulnerability to Drug Abuse
by Nick E. Goeders

Stress, Motivation, and Drug Addiction
by Nick E. Goeders

Effects of Corticotropin-Releasing Hormone Receptor Antagonists on Cocaine-Induced Dopamine Overflow in the Medial Prefrontal Cortex and Nucleus Accumbens of Rats
by Olga V. Gurkovskaya, Vitaly Palamarchouk, Gennady Smagin, And Nick E. Goeders

Effects of surgical and pharmacological adrenalectomy on the initiation and maintenance of intravenous cocaine self-administration in rats
by N.E. Goeders and G.F. Guerin

Effects of the CRH Receptor Antagonist CP-154,526 on Intravenous Cocaine Self-administration in Rats
by Nick E. Goeders, Ph.D., and Glenn F. Guerin, B.S.

Ketoconazole reduces low dose cocaine self-administration in rats
by Nick E. Goeders, Rachel L. Peltier and Glenn F. Guerin

Potential role for the hypothalamo-pituitary-adrenal axis in the conditioned reinforcer-induced reinstatement of extinguished cocaine seeking in rats
by Nick E. Goeders and David M. Clampitt

Stress and Cocaine Addiction
by Nick E. Goeders

The HPA axis and cocaine reinforcement
by Nick E. Goeders

The impact of stress on addiction
by Nick E. Goeders

Terms of Use - Privacy Policy