Solvay Pharmaceuticals recently signed extensive agreements with Wyeth Pharmaceuticals to co-develop and co-commercialize several central nervous system (CNS) compounds. The compounds in development include bifeprunox, and three others (SLV310, SLV 313 and SLV 314) in early clinical development for the possible treatment of schizophrenia, bipolar disorder or a variety of other CNS conditions.
Bifeprunox and the other three SLV compounds are the product of Solvay Pharmaceuticals’ research and developments efforts. Solvay Pharmaceuticals developed bifeprunox together with our skilled partner Lundbeck.
Bifeprunox is being studied in phase III clinical trials. We are confident that with bifeprunox, we are developing a compound that will offer additional benefits to patients suffering from schizophrenia and bipolar disorder. Bifeprunox is expected to be as efficacious as current treatment with an improved safety profile.
Bifeprunox is a partial agonist at the dopamine D2 receptors and the serotonin 5-HT1A receptors. Dopamine and serotonin are so called ‘neurotransmitters’. Neurotransmitters are chemical messengers. They transmit nerve signals (impulses) from one nerve cell (neuron) to another. Dopamine and serotonin are both involved in the regulation of emotions.
Central Nervous System (CNS)
The Central Nervous System (CNS) is the collective name for the brain and the spinal cord. The CNS contains billions of nerve cells called neurons. They are the body’s ‘controlling’ cells. They perform many of the more complex functions in humans and animals including thought, memory, control of bodily functions (both conscious and unconscious), processing of sensory information, voluntary and involuntary movement and transmission of nerve signals both to and from all parts of body.
Schizophrenia is a psychiatric disorder characterized by profound disturbances in thinking and perception. Prominent symptoms are delusions, hallucinations and social withdrawal. Clarity of consciousness and intellectual capacity are usually intact, although cognitive symptoms may arise. Depressive symptoms are common. The disease is often chronic. It is one of the most common psychotic disorders and is frequently associated with poor social skills and occupational performance. In addition to the suffering experienced by the patients and their families, schizophrenia represents an enormous cost for the health care system and the society.
Approximately 1 percent of the population develops schizophrenia during their lifetime. Schizophrenia usually appears in young adulthood.
Schizophrenia is a severely debilitating psychiatric disorder with fundamental disturbances in thinking and perception. Symptoms encompass a wide range of dysfunctions such as: delusions (often persecutory, referential or somatic and bizarre in nature); hallucinations (most often auditory in the form of voices conversing or commenting the patient); disorganized speech (incoherence, irrelevant speech, neologisms); and behavioral disturbances (e.g. difficulties in activities of daily living, apparently unmotivated agitation, catatonic behavior). These symptoms are often referred to as positive symptoms because they may be considered as an excess or distortion of normal functions. Negative symptoms are also an important feature of schizophrenia. Negative symptoms encompass such features as absence of emotion, lack of motivation and social withdrawal and by their nature can be particularly disabling. They tend to be associated with long term unremitting illness. Approximately one half of patients has recurrent illness and often has enduring negative symptoms, such as apathy and social withdrawal, between florid psychotic episodes.
The sudden onset of severe psychotic symptoms is referred to as an “acute” phase of schizophrenia. Some people have only one such psychotic episode; others have many episodes during a lifetime, but lead relatively normal lives during the interim periods. However, the individual with “chronic” schizophrenia, or a continuous or recurring pattern of illness, often does not fully recover normal functioning and typically requires long-term treatment, generally including medication, to control the symptoms.
Medications and other treatments for schizophrenia, when used regularly and as prescribed, can help reduce and control the distressing symptoms of the illness. Even when treatment is effective, persisting consequences of the illness – lost opportunities, stigma, residual symptoms, and medication side effects – may be very troubling.
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in a person’s mood, energy, and ability to function. Different from the normal ups and downs that everyone goes through, the symptoms of bipolar disorder are severe. Cycles, or episodes, of depression, mania, or “mixed” manic and depressive symptoms typically recur and may become more frequent. They can result in damaged relationships, poor job or school performance, and even suicide.
The lifetime prevalence for bipolar disorder ranges from 0.3% to 1.6%. Bipolar disorder typically develops in late adolescence or early adulthood. However, some people have their first symptoms during childhood, and some develop them late in life. Like diabetes or heart disease, bipolar disorder is a long-term illness that must be carefully managed throughout a person’s life.
Depression: Symptoms include a persistent sad mood; loss of interest or pleasure in activities that were once enjoyed; significant change in appetite or body weight; difficulty sleeping or oversleeping; physical slowing or agitation; loss of energy; feelings of worthlessness or inappropriate guilt; difficulty thinking or concentrating; recurrent thoughts of death or suicide.
Mania: Abnormally and persistently elevated (high) mood and/or irritability accompanied by at least three of the following symptoms (four if the mood is merely irritable): overly-inflated self-esteem; decreased need for sleep; increased talkativeness; racing thoughts; distractibility; increased goal-directed activity such as shopping; physical agitation; hypersexuality; excessive involvement in risky behaviors or activities.
“Mixed” state: Symptoms of mania and depression are present at the same time. The symptom picture frequently includes agitation, trouble sleeping, significant change in appetite, psychosis, and suicidal thinking. Depressed mood accompanies manic activation.
Most people with bipolar disorder can be helped with treatment. A variety of medications are used to treat manic-depressive illness (lithium, mood- stabilising medication, antidepressants, antipsychotics and benzodiazepines). Psychotherapy, in combination with medication, often can provide additional benefit.