Feb. 03, 2011Products
Dainippon Sumitomo Pharma Co. Ltd. (DSP) Announces Launch of Latuda (lurasidone HCl) in the United States
Dainippon Sumitomo Pharma Co., Ltd. (DSP) (DSP, Headquarters: Osaka, Japan; President: Masayo Tada) today announced the launch of LATUDA® (lurasidone HCl) tablets (40 mg and 80 mg tablet strengths) in the United States by Sunovion Pharmaceuticals Inc., a subsidiary of DSP, as of February 4, 2011. LATUDA is a once-daily atypical antipsychotic agent approved by the U.S. Food and Drug Administration (FDA) on October 28, 2010 for the treatment of patients with schizophrenia.
"The U.S. launch of LATUDA is a significant achievement for our company and brings us closer to our goal of growing as an internationally recognized global pharmaceutical company," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. "This launch is the result of a tremendous collaboration between DSP and our U.S. colleagues at Sunovion Pharmaceuticals who worked tirelessly to launch LATUDA.
With the launch of LATUDA in the U.S, I am delighted that we have this important new treatment option for patients with schizophrenia."
The impact of the LATUDA launch on the company financial results for FY2011 will be announced with the FY2010 financial results announcement in May 2011.
LATUDA is an atypical antipsychotic indicated for the treatment of patients with schizophrenia.
Efficacy was established in four 6-week controlled studies of adult patients with schizophrenia.
The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
The recommended starting dose for LATUDA is 40mg/day taken with food (at least 350 calories) with no initial dose titration required. The maximum recommended dose is 80 mg/day. For patients with moderate to severe renal or hepatic impairment, the dose of LATUDA should not exceed 40 mg/day. LATUDA should not be administered with strong CYP3A4 inhibitors such as ketoconazole or strong CYP3A4 inducers such as rifampin.