Product
Latuda
Approval Date
October 28, 2010
Release Date
February 2011
Company
Sunovion
Class
Atypical antipsychotic
Indication
For the treatment of schizophrenia in adults
Active Ingredient
Lurasidone HCl
Agency Roster
Abelson-Taylor (professional)
Marketing Strategy/Execution
Sunovion, the US subsidiary of Japanese drug maker Dainippon Sumitomo Pharma Co., will market Latuda to those patients and their physicians who are interested in a new treatment option for adults with schizophrenia. Messaging will likely advocate the drug as an alternative which does not cause weight gain, sedation or cognitive side effects in patients. And, since compliance is an important issue in this population, the once-daily dosing regimen may also figure in ads. The company says it will employ a variety of channels to commercialize the drug, which is part of the atypical antipsychotics class—the top-selling drug class in the US in 2009, with combined sales of $14.6 billion. Latuda should be available in February 2011.
Physician Outlook
Physicians will find value for patients who have failed other longer established agents. I suspect we will hear more about improved cognition in conversations about this product, but how Latuda will differentiation itself from other available agents based on this treatment benefit and others like “less impact on weight gain” must be deemed as “wait and see” for now.
—Geoff Penney, Vice President, Research, GfK HealthCare
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: OPC 14597
Manufacturer:Bristol-Myers Squibb
Indication: Bipolar disorders
Active ingredient: Aripiprazole
Phase: III
Drug: MP 214
Manufacturer: Forest Laboratories
Indication: Bipolar disorders
Active ingredient: Cariprazine
Phase: III
Drug: ALXZ-004
Manufacturer: Alexza Pharmaceuticals
Indication: Schizophrenia
Active ingredient: Loxapine inhalation
Phase: Preregistration
Drug: Paliperidone palmitate
Manufacturer: Johnson & Johnson
Indication: Schizoaffective disorder
Active ingredient: Paliperidone
Phase: III
Drug: LY 404039 prodrug
Manufacturer: Eli Lilly
Indication: Schizophrenia
Active ingredient: LY 2140023
Phase: II/III
Source: Wolters Kluwer Pharma Solutions
Adverse Reactions
Somnolence, akathisia, nausea, parkinsonism, agitation; orthostatic hypotension, syncope, hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia, leukopenia/neutropenia, possible NMS, tardive dyskinesia.
Adults
Take with food (≥350 calories). 40mg once daily. Max 80mg/day. Moderate to severe renal or hepatic impairment, concomitant moderate CYP3A4 inhibitors: max 40mg/day.
Children
Not recommended.
Contraindications
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole) and inducers (eg, rifampin).
Precautions
Elderly (not for dementia-related psychosis); increased risk of death. Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Moderate to severe hepatic or renal impairment. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia. History of seizures. Exposure to extreme heat. Dysphagia. Write ℞ for smallest practical amount. Pregnancy (Cat. B). Nursing mothers.
