Lurasidone

ArticlesMedicine Compliance Aid StabilityLactation Safety InformationNew Medicines ·
26664311000001101

Articles

Medicine Compliance Aid Stability

LatudaSunovion Pharmaceuticals Europe Ltd

Sunovion Pharmaceuticals Europe Ltd
Latuda
Tablets f/c 18.5mg, 37mg, 74mg.
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light.
1 October 2015

Lactation Safety Information

No published evidence of safety
Low levels anticipated in milk due to the drug’s properties
Long half-life increases risk of accumulation in breastfed infants
9 November 2018

New Medicines

LatudaSchizophrenia in children and adolescents aged 13 years and older

Information

Latuda
Licence extension / variation
Sunovion
Dainippon Sumitomo

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
July 2020
Jul 20Licence extension to include use in adolescents aged 13 and over approved in the EU [5].
Jul 20Recommended for EU approval by CHMP - the amended indication is "for the treatment of schizophrenia in adults and adolescents aged 13 years and over." [4]

Category

Dopamine D2 receptor & serotonin 5HT2A/7 receptor antagonist
Childhood schizophrenia affects about 1.6 to 1.9 per 100,000 child population, prevalence increasing from the age of 14 years onwards [1].
Schizophrenia in children and adolescents aged 13 years and older
Oral