Latuda
Psychiatry· 1442 cited findings· 2 source documents
Company: Angelini Pharma
What the regulatory reviews say
Latuda (lurasidone) is a drug indicated for the treatment of schizophrenia. The effective dose range for Latuda is 37 to 148 mg once daily. Lurasidone demonstrates high binding affinity for several receptors, including dopamine D2-receptors (0.994 nM), serotonergic 5HT2A-receptors (0.47 nM), and serotonergic 5-HT7-receptors (0.495 nM). It also exhibits partial agonistic effect at the 5HT1A receptor with a binding affinity of 6.38 nM.
Regulatory review documents indicate that the Marketing Authorisation Application for Latuda was submitted on 27 September 2012, following agreement for a centralised procedure by EMA/CHMP on 15 March 2012. The drug received Marketing Authorisation in the USA on 28 October 2010. Clinical development included 12 short-term studies, typically lasting 6 weeks, and 9 long-term studies, with pivotal studies extending to 12 months.
In terms of safety, 79% of subjects receiving lurasidone reported one or more treatment-emergent adverse events (TEAEs), compared to 72% in the placebo group. Discontinuation due to TEAEs was 9% for both lurasidone and placebo groups. Study medication-related TEAEs were reported by 72% of subjects receiving lurasidone 120 mg.
Key figures — cited to the source page
| Lurasidone binding affinity for dopamine D2-receptors | 0.994 nM | Angelini Pharma — Latuda EMA EPAR public assessment report, p.8 |
| Lurasidone binding affinity for serotonergic 5HT2A-receptors | 0.47 nM | Angelini Pharma — Latuda EMA EPAR public assessment report, p.8 |
| Effective dose range of Latuda | 37 to 148 mg once daily | Angelini Pharma — Latuda EMA EPAR public assessment report, p.8 |
| Proportion of subjects reporting one or more TEAE (lurasidone) | 79 % | Angelini Pharma — Latuda EMA EPAR public assessment report, p.53 |
| Discontinuation due to TEAE (lurasidone) | 9 % | Angelini Pharma — Latuda EMA EPAR public assessment report, p.53 |
| Marketing Authorisation Application submission date | 27 September 2012 | Angelini Pharma — Latuda EMA EPAR public assessment report, p.5 |
| Marketing Authorisation in USA | 28 October 2010 | Angelini Pharma — Latuda EMA EPAR public assessment report, p.6 |
| Indication applied for | treatment of schizophrenia | Angelini Pharma — Latuda EMA EPAR public assessment report, p.5 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.