Abbott Laboratories submits New Drug Application for sertindole for treatment of psychosis -- new treatment shows promise against the symptoms of schizophrenia.ABBOTT PARK, Ill.--(HealthWire)--Oct. 9, 1995--Abbott Laboratories has submitted a New Drug Application to the U.S. Food and Drug Administration, seeking clearance for the use of sertindole to treat the manifestations of psychotic disorders including the positive and negative symptoms Negative symptoms Symptoms of schizophrenia characterized by the absence or elimination of certain behaviors. DSM-IV specifies three negative symptoms: affective flattening, poverty of speech, and loss of will or initiative. Mentioned in: Schizophrenia of psychosis. More than two million Americans suffer from schizophrenia, a chronic and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction mental disorder mental disorder Any illness with a psychological origin, manifested either in symptoms of emotional distress or in abnormal behaviour. Most mental disorders can be broadly classified as either psychoses or neuroses (see neurosis; psychosis). Psychoses (e.g. that costs the U.S. health care system $33 billion annually. Physicians estimate that up to 50 percent of patients do not respond adequately to available medications. Research results suggest that sertindole may treat the symptoms of schizophrenia and other psychotic conditions. In two, eight-week controlled clinical trials that compared sertindole to standard antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic therapy (haloperidol haloperidol /hal·o·peri·dol/ (hal?o-per´i-dol) an antipsychotic agent of the butyrophenone group with antiemetic, hypotensive, and hypothermic actions; used especially in the management of psychoses and to control vocal utterances and ) and placebo in hospitalized patients, sertindole and standard therapy demonstrated significant and comparable improvements in the positive symptoms of schizophrenia. Additionally, sertindole demonstrated significant improvement in the negative symptoms of schizophrenia. Positive symptoms include symptoms such as delusions and hallucinations Hallucinations Definition Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even . Negative symptoms of the condition can include diminished emotional expressiveness, decreased fluency and productivity of speech, and an inability to initiate and persist in goal-directed activities. In these clinical trials, the occurrence of Parkinsonian-like movement side effects between sertindole and placebo was not statistically significant, while both showed significant superiority to standard therapy. Nineteen percent of sertindole-treated patients (number equals 520) experienced Parkinsonian-like movement side effects vs. 22 percent of placebo-treated patients (number equals 231), and 50 percent of patients treated with the standard therapy (number equals 364). Parkinsonian-like adverse events (also called extrapyramidal symptoms) can cause extreme discomfort and be confused with psychotic symptoms. Adverse events with an incidence of 5 percent or more in patients treated with sertindole and at least twice that of placebo were: dry mouth, nasal congestion, vaginitis vaginitis Inflammation of the vagina. The chief symptom is a whitish or yellowish vaginal discharge. Treatment depends on the cause: appropriate drugs for sexually transmitted diseases (often from Gardnerella bacteria or trichomonads) or yeast infections; estrogen cream for , and, in male patients, decreased ejaculatory e·jac·u·la·to·ry adj. Relating to an ejaculation. volume. Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1994, the company's sales and net earnings were $9.2 billion and $1.5 billion, respectively, with earnings per share of $1.87. CONTACT: Abbott Laboratories, Abbott Park Laureen Cassidy, 708/938-7743 or Douglas Petkus, 708/938-3531 |
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