Location: Therapeutic Areas

Addiction and obesity continue to be significant problems that plague the United States and the rest of the world and are responsible for significant healthcare costs (See Figure 1). Most of the medications currently being used or considered for the treatment of substance abuse either (i) rely on the neurochemistry of the abused substance to try to block the effects (not prevent the use) of the addictive substance or (ii) mimic the effects of the addictive substance. In obesity, currently approved treatments alter the patient’s metabolism, reduce appetite, or act on selected receptors in the brain to reduce food intake; no currently approved medications address craving. These treatment strategies have seen limited success as evidenced by the meager proportion of the addicted population that successfully quits and the stable or growing populations of addicted and obese individuals. 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 addictive substances. Despite this research, there are currently very few marketed medications to treat addiction and none which specifically target craving.

Embera is developing EMB-001 to address the currently unmet need for effective treatments to blunt craving in addiction and obesity that can be incorporated into a comprehensive treatment program. Embera’s focus will be on those disorders where alleviating craving could play an integral role in successful treatment of the patient. These include:

Alcohol and Cocaine Addiction

According to the 2007 National Survey on Drug Use and Health conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA), an estimated 22.3 million Americans aged 12 or older in 2007 were classified with substance dependence or abuse in the prior year (9.4 percent of the total population). Of these, 3.2 million were dependent on or abused both alcohol and illicit drugs, and 15.5 million were dependent on or abused only alcohol. Of the 6.9 million persons classified with dependence on or abuse of illicit drugs, 1.6 million were dependent on or abused cocaine. Alcohol and illicit drug abuse treatment expenditures alone exceeded $21 billion in the U.S. in 2003¹. When considering all direct medical costs, the impact on the healthcare system exceeds $41 billion.

Nicotine Addiction

An estimated 43.4 million U.S. adults smoke cigarettes (19.8% of the population). Of this group, the majority (33.8 million) use cigarettes daily. While the percent of the population that uses cigarettes has declined from 20.8% in 2006 to 19.8% in 2007, cigarette smoking is still widespread and poses a significant long term health risk to those addicted to nicotine in cigarettes. Approximately 40% of smokers attempt to quit each year, resulting in a potential patient population motivated to seek treatment of 13.5 million daily smokers. When those who do not smoke daily are considered, this number increases to as many as 17.3 million smokers. ²

The costs associated with nicotine addiction place a tremendous burden on society. In the U.S. alone, cigarette smoking results in 440,000 deaths each year and $96 billion for direct medical care. Smoking remains the leading preventable cause of premature death in the United States, and lung cancer continues to be the leading cause of cancer deaths in both men and women.³

The need for new approaches is clear given that most smokers do not use cessation treatment (64%)⁴ and experience limited success in quitting (4-7% are successful). This limited success improves marginally when the smoker utilizes cessation treatments. A study that included 12,700 smokers using smoking cessation treatments found that 16.4% of the smokers were abstinent for at least 4 months at the time of survey.⁵

Obesity Population

Obesity has reached epidemic proportions in the U.S. In 2006, 67% of the population was reported to be overweight or obese (Body Mass Index > 25) and this number continues to grow. From 1994 to 2006 the obesity rate more than doubled from 15% of the U.S. population to 35%. Today, one third of the population (or 72 million people) is estimated to be obese.⁶ The costs associated with obesity rival those associated with smoking, resulting in 300,000 U.S. deaths annually and $117 billion in costs related to obesity, of which $61 billion are direct healthcare costs.⁷ This figure includes costs associated with cardiovascular disease, certain cancers, type 2 diabetes, arthritis, breathing disorders, and psychological disorders such as depression.

Food cravings have been associated with eating disorders such as binge eating and obesity.⁸ In a random sample of women, 21% reported having food cravings of strong intensity. Three percent (3%) of the obese population in the U.S. or 1.6 million people are binge eaters.⁹ This population rivals the cocaine dependent population.

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