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The FDA approved Sunovion Pharmaceuticals' Latuda (lurasidone HCL), an atypical antipsychotic used to treat schizophrenia in adults 18 years and older.
Sunovion Pharmaceuticals’ Latuda
On October 28, 2010, the FDA approved Sunovion Pharmaceuticals’ Latuda (lurasidone HCl), an atypical antipsychotic used to treat schizophrenia in adults 18 years and older. Latuda functions to reduce dopamine and serotonin levels to help control both positive and negative symptoms associated with schizophrenia.1 The approval was based on four 6-week clinical trials.2
The mechanism of action of lurasidone is largely unknown, although it is believed to antagonize type 2 dopamine receptors and type 2 serotonin receptors. Lurasidone functions through the activity of the parent drug, achieving peak plasma concentrations in 1 to 3 hours, and reaching steady-state concentrations within 7 days of the first dose. When taken with food, lurasidone reaches maximum concentration 3 times faster than when taken without food.3
Dosage and Administration
Latuda is available in tablet form in doses of 40 and 80 mg. When starting Latuda, it is suggested that patients begin with a daily dose of 40 mg and recommended that a patient’s daily dose not exceed 80 mg.3 Latuda should be taken once daily with a meal consisting of at least 350 calories.3
Because it undergoes hepatic metabolism by cytochrome P450 (CYP) 3A4 enzyme, Latuda should not be coadministered with strong CYP3A4 inhibitors or strong CYP3A4 inducers, as this may affect the absorption of Latuda. When given with moderate CYP3A4 inhibitors, the maximum recommended dose is 40 mg per day. For those patients with hepatic or renal impairments, daily dosage should not exceed 40 mg. Due to the fact that efficacy and safety of Latuda for use longer than 6 weeks has not been established, prescribers should intermittently assess its value as a long-term treatment.3
The most frequent side effects associated with Latuda are tachycardia, blurred vision, abdominal pain, and diarrhea. Decreases in appetite and rash/pruitus are also common. Those patients taking Latuda are at risk for developing extrapyramidal symptoms, including dystonia, parkinsonism, and restlessness, in addition to neuroleptic malignant syndrome and tardive dyskinesia. In some cases, Latuda can cause hyperprolactinemia, orthostatic hypotension, leucopenia, seizures, and the potential for suicide. As with most atypical antipsychotics, metabolic changes such as weight gain and hyperglycemia are also possible.3
The safety and efficacy of Latuda was examined through the PEARL (Program to Evaluate the Antipsychotic Response to Lurasidone) 3 study. This study completed the third phase-3 worldwide clinical trial of Latuda.2
Latuda was analyzed in a 6-week, double-blind, fixed-dose, placebo-controlled trial involving 488 patients diagnosed with schizophrenia and with a Positive and Negative Syndrome Scale (PANSS) score totaling 80 or higher. Subjects were assigned to receive once daily dosing of 80 or 160 mg of Latuda or placebo. In this trial, an active comparator group received 600 mg of quetiapine XR once daily.
The primary efficacy end point was the change in the subjects’ total score on the PANSS scale. At week 6, subjects taking 80 and 160 mg of Latuda showed improvements of -22.2 and -26.5 respectively, whereas the placebo group only experienced an improvement of -10.3. These improvements showed as early as 4 days from the first dose. Additionally, patients taking 80 and 160 mg of Latuda showed improvements of -1.5 and -1.7 on the Clinical Global Impression Severity scale at week 6, the secondary efficacy end point, whereas the placebo group only experienced an improvement of -0.9.3
At the conclusion of the study, it was shown that Latuda was well-tolerated by patients and its discontinuation rate was lower than that of the placebo. The most commonly reported adverse events included akathisia, nausea, parkinsonism, dizziness, and somnolence. Lastly, weight gain and cholesterol/lipid measurements were similar for Latuda and placebo. Overall, Latuda was well received by patients and the overall safety profile of the drug did not change based on study.3 It is important to note the 160 mg/day dose has not been evaluated and approved by the FDA.
As with other antipsychotics, Latuda carries a boxed warning and should not be prescribed for elderly patients with dementia-related psychosis, as these patients are at an increased risk of death when treated with antipsychotics. The safety and effectiveness of Latuda in pediatric patients has yet to be established.3 Currently, there is little information known about the effects of Latuda on a human fetus. It is considered a pregnancy category B medication, and should only be taken by pregnant and breast-feeding women if “the potential benefit justifies the potential risk to the fetus.”1 PT
Both Ms. Belisle and Dr. Patel are pharmacists at Brigham and Women’s Hospital, Boston, Massachusetts. Ms. Platt and Ms. Vautrin are third-year PharmD candidates at Northeastern University School of Pharmacy in Boston, Massachusetts.
1. Sunovion Pharmaceuticals, Inc. announces commercial availability of Latuda® (lurasidone hydrochloride) for the treatment of schizophrenia in adults [press release]. Fort Lee, NJ: Sunovion Pharmaceuticals, Inc. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231512.htm. Accessed May 2, 2011.
2. Latuda [news release]. Marlborough, MA: Sunovion Pharmaceuticals, Inc; December 8, 2010.
3. Latuda [product information]. Marlborough, MA: Sunovion Pharmaceuticals, Inc; October 2010.