Mental Health Disorders
July 14, 2010
America’s pharmaceutical research and biotechnology companies are currently developing 313 medicines to help the nearly 60 million American adults today suffering from some form of mental illness—from Alzheimer’s disease to depression and from schizophrenia to addictive disorders, such as dependence on alcohol or drugs. All of the medicines are either in clinical trials or awaiting review by the Food and Drug Administration. (Click here to see full report.)
Over the past half century, pharmaceutical research has helped transform mental illnesses from misunderstood causes of shame and fear into often highly treatable conditions. For example, medicines for treating depression are helping thousands of people suffering from this disease live productive lives. Breakthrough schizophrenia medicines enable most patients to be treated in the community rather than institutional settings, and medicines for Alzheimer’s disease are helping elderly people maintain their independence longer.
Despite such progress, mental illnesses continue to exact a heavy human and economic toll. The National Institute of Mental Health (NIMH) estimates that 1 in 4 American adults suffer from a diagnosable mental disorder. According to the World Health Organization, more than 300 million people worldwide suffer from a mental health disorder. Mental illness, including suicide, accounts for more than 15 percent of the burden of disease in established market economies, which is more than the disease burden caused by all cancers. According to a study funded by the NIMH, serious mental illnesses cost the United States more than $317 billion annually in lost wages, health care expenditures and disability benefits.
New medicines today in the research and development pipeline offer hope of reducing the human and economic costs of mental illnesses. They include: 71 for depression (mood disorders), which affects nearly 21 million Americans; 33 for addictive disorders, including dependence on alcohol, tobacco or illicit drugs; 38 medicines for anxiety disorders, which affect more than 40 million adults ages 18 and older; 90 for dementias, including Alzheimer’s disease, which affects more than 5 million Americans; and 54 for schizophrenia, which strikes some 2.4 million American adults each year. Other potential medicines target attention-deficit/hyperactivity disorder, autism, eating disorders, personality disorders, premenstrual disorders and sleep disorders.
Alzheimer’s disease: More than 5 million Americans are living with Alzheimer’s disease, according to
the Alzheimer’s Association. Some 5.1 million people with Alzheimer’s are age 65 and older, but at least 500,000 people younger than age 65 either have early-onset Alzheimer’s or another dementia. A potential medicine in development is a humanized monoclonal antibody designed to remove beta amyloid protein from the brain and prevent or reverse progression of Alzheimer’s disease. The medicine provides the patient with antibodies (proteins involved in the body’s immune response) directly, rather than the patient having to create their own immune response to beta amyloid. This process – called passive immunization – may provide greater reduction of safety concerns due to the lack of stimulation to the patient’s immune response to beta amyloid. (bapineuzumab, Pfizer/Janssen, Phase III)
Anxiety (Social Phobia): Anxiety disorders affect more than 40 million adults in the U.S., with about 15 million of those suffering from acute social phobia, according to the National Institute of Mental Health. A potential medicine in development is part of a new class of psychotropic pherines. The drug, which has a unique mechanism of action, is administered in an intranasal spray and acts with rapid-onset on peripheral receptors from nasal chemosensory neurons that act on the hypothalamic-limbic system in the brain, which is thought to be the primary center of emotion. In clinical trials, it was shown to improve social performance and social interaction anxiety within 10 minutes of administration. (PH84B, Pherin Pharmaceuticals, Phase II)
Attention-Deficit/Hyperactivity Disorder: Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common reasons children in the United States are referred for mental health services. It affects as many as one in every 20 children and can persist into adulthood, according to Mental Health America. A new medicine in development targets specific types of neuronal nicotinic receptors (NNRs) found on the nerve cells in the central nervous system. NNRs modulate the release of several neurotransmitters, like acetylcholine and dopamine, and control the flow of neuron signaling. In clinical trials it has shown to improve the core symptoms of ADHD, improve quality-of-life and work effectiveness and reduce overall work impairment in adults with ADHD. (sofinicline, Abbott Laboratories, Phase II)
Cocaine Addiction: The National Institute on Drug Abuse estimates that about one in six Americans – 15 percent in 2007 – have tried cocaine by the age of 30. Currently no medication addresses cocaine addiction, but a therapeutic vaccine in development may prove an effective treatment. The vaccine is designed to induce cocaine-specific antibodies that bind to cocaine in the blood, blocking its uptake into the brain. The physiological response to cocaine is thus altered, reducing the reinforcing properties of cocaine and permitting patients to break the cycle of addiction. (TA-CD, Xenova Group, Phase II)
Depression: Mood disorders – major depressive disorder, dysthymic disorder, and bipolar disorder – affect nearly 21 million American adults, or 9.5 percent of the U.S. population, according to the National Institute on Mental Health. A key chemical in regulating the stress hormone cortisol is a brain hormone called corticotrophin-releasing factor (CRF). In patients with major depression the CRF hormone is overproduced and may also trigger anxiety-related disorders. The receptors for CRF are found in specific brain regions that are responsible for the regulation of mood. One medicine in development is a CRF receptor antagonist that offers a novel mechanism of action with the potential advantage of being more selective, potentially increasing efficacy and having a more rapid onset of action than current therapies while potentially reducing the number of side effects. (verucerfont, GlaxoSmithKline/Neurocrine, Phase II)
Depression with Anxiety: Nearly one-half of people diagnosed with depression are also diagnosed with an anxiety disorder, according to the Anxiety Disorders Association of America. Recent discoveries linking neurogenesis – the process by which stem cells in the adult human brain produce new brain tissue, including neurons – to central nervous system disease have presented new opportunities for addressing brain-related illness. A potential neurogenic treatment for depression with anxiety has the ability to help neurons differentiate and survive, two important aspects of the neurogenesis process. Because it also benefits from a novel mechanism that does not affect serotonin levels, it potentially eliminates negative side effects typical of medicines that act on serotonin. (BCI-540, BrainCells, Phase II)
Insomnia: The National Center for Sleep Disorders Research at the National Institutes of Health, estimates about 30-40 percent of adults have some symptoms of insomnia within a given year, and about 10-15 percent of adults have chronic insomnia. A first-in-class medicine in development targets the protein orexin in the brain, which regulate the sleep-wake cycle. By interacting with the hormones, the medicine could help to reduce or eliminate some of the side effects associated with current insomnia sleep treatments. It penetrates the blood-brain barrier to induce sleep without affecting REM sleep. (almorexant, Actelion and GlaxoSmithKline, Phase III)
Obesity: An estimated 32.7 percent of adult American over age 20 are overweight, 34.3 are obese and 5.9 percent are extremely obese, according to the U.S. Centers for Disease Control and Prevention. A naturally-occurring peptide hormone in the brain – endogenous opioids – enhances the pleasurable response to sugary and fatty foods. A potential medicine in development potentially stops this effect and may contribute to weight loss in obese patients. (1521498, GlaxoSmithKline, Phase I)
Schizophrenia: Schizophrenia affects some 2.4 million American adults, or 1.1 percent of the U.S. population, according to the National Institute on Mental Health. Symptoms of schizophrenia are typically divided into positive and negative because of their impact on diagnosis and treatment. Positive symptoms are those that appear to reflect an excess or distortion of normal functions, while negative symptoms are those that appear to reflect a diminished or loss of normal functions. One potential medicine in development has shown to relate to both the types of symptoms in animal studies. In addition, the medicine may also have a very low potential for side effects associated with some antipsychotic medicines. (LY2140023, Eli Lilly, Phase II)
* From Medicines in Development for Mental Illnesses, PhRMA, 2010
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