Latuda (lurasidone HCl), an atypical antipsychotic class of drug, in tablet form, has been approved by the FDA (Food and Drug Administration). According to the FDA, approximately 1% of US adults are affected by schizophrenia in any given year. Schizophrenia, a mental disorder, generally appears during early adulthood or late adolescence, although it can do so at any time. Males who develop the disorder generally do so between the ages of 15 and 25, while among females onset of signs and symptoms usually appear between 25 and 35 years of age. Typically, it develops slowly and the patient is unaware of what is wrong for a long time. Sometimes though, it can strike suddenly and progress rapidly.
Schizophrenia is a complex, long-term (chronic), severe and disabling brain disorder, and is probably several illnesses masquerading as one, many experts believe. Symptoms include hallucinations (hearing things much more common than seeing things that are not there), delusions, disordered behavior, disordered thinking, and suspiciousness/paranoia.
Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said:
Schizophrenia can be a devastating illness requiring lifelong treatment. Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.
Latuda is an atypical antipsychotic; it contains a boxed warning that tells doctors there is a higher risk of death linked to off-label use when treating elderly patients with dementia-related psychosis.
Currently, there is not approved medication for behavioral problems in elderly patients with dementia-related psychosis.
Four clinical trials, lasting six weeks each, showed that participants taking Latuda had fewer signs and symptoms of schizophrenia compared to those on a placebo (dummy drug).
Some patients may experience drowsiness, restlessness, tremors, muscle stiffness, agitation and nausea.
Latuda is made and marketed by Sunovion Pharmaceuticals Inc., a US subsidiary of Dainippon Sumitomo Parma Co. Ltd.
Sunovion says Laduta is a first-line treatment option for individuals with schizophrenia. The company expects the medication to become available in the USA during the first three months of 2011.
Masayo Tada, President and CEO of Dainippon Sumitomo Parma Co. Ltd., said:
Laduta marks both a significant achievement for our company as well as the first FDA approval for Sunovion since becoming a US subsidiary of Dainippon Sumitomo Parma Co. Ltd. With this approval, we've taken another big step towards becoming a truly competitive global company by enhancing the presence of Sunovion in the USA.
Dr. Antony Loebel, executive Vice President, Clinical Research and Medical Affairs, Sunovion, said:
Latuda offers a once-daily treatment option that has been shown to be both effective and tolerable, adding to psychiatrists' ability to address the challenging therapeutic needs of people with schizophrenia.
The company adds that the effectiveness of Latuda for longer than 6 weeks - long-term use - has not been established in controlled studies. Therefore doctors choosing to use the medication for long periods should monitor the patient carefully and regularly.
Sources: FDA, Sunovion
Written by Christian Nordqvist