SUPPLEMENTARY TABLE 2.
Clinical outcome assessments in approved antipsychotic agents (2010–2020)
| DRUG, GENERIC NAME (BRAND NAME) | APPROVAL DATE | SPONSOR | AGENCY | COA IN LABELa |
|---|---|---|---|---|
| Lumateperone (Caplyta) | 20-Dec-19 | Intra-Cellular Therapies, Inc. (NY, US) | FDA | PANSS |
| Asenapine (Secuado) | 11-Oct-19 | Hisamitsu Pharmaceutical Co., Inc. (FL, US) | FDA | PANSS, CGI-I |
| Brexpiprazole (Rexulti) | 26-Jul-18 | Otsuka Pharmaceutical Netherlands B.V. | EMA | PANSS, CGI-S |
| Aripiprazole (Abilify MyCite) | 13-Nov-17 | Otsuka Pharmaceutical Company, Ltd. (NJ, US) | FDA | PANSS, CGI-S |
| Cariprazine (Reagila) | 13-Jul-17 | Gedeon Richter, Ltd. (Hungary) | EMA | PANSS, CGI-S |
| Aripiprazole lauroxil (Aristada) | 5-Oct-15 | Alkermes, Inc. (MA, US) | FDA | PANSS, CGI-I |
| Cariprazine (Vraylar) | 17-Sep-15 | Allergan Sales, LLC (NJ, US) | FDA | PANSS, CGI-S |
| Brexpiprazole (Rexulti) | 10-Jul-15 | Otsuka Pharmaceutical Company, Ltd. (MD, US) | FDA | PANSS |
| Paliperidone (Invega Trinza) | 18-May-15 | Janssen Pharmaceuticals, Inc. (NJ, US) | FDA | PANSS |
| Paliperidone (Trevicta) | 9-Dec-14 | Janssen-Cilag International NV (Belgium) | EMA | PANSS, PSP |
| Lurasidone hydrochloride (Latuda) | 21-Mar-14 | Aziende Chimiche Riunite Angelini Francesco S.p.A. (Italy) | EMA | PANSS, CGI-S |
| Aripiprazole (Abilify Maintena) | 15-Nov-13 | Otsuka Pharmaceutical Netherlands B.V. | EMA | Relapse,b PANSS, PSP |
| Aripiprazole (Abilify Maintena) | 28-Feb-13 | Otsuka Pharmaceutical Company, Ltd. (MD, US) | FDA | PANSS, CGI-I, Relapse |
| Paliperidone (Xeplion) | 4-Mar-11 | Janssen-Cilag International NV (Belgium) | EMA | PANSS, PSP |
| Lurasidone hydrochloride (Latuda) | 28-Oct-10 | Sunovion Pharmaceuticals, Inc. (MA, US) | FDA | PANSS, BPRSd, CGI-S |
aBy necessity, COAs contained in labels are generally restricted to the primary and key secondary outcomes; additional secondary and exploratory outcomes are usually not mentioned in labels but can be found in regulatory documents (e.g., drug approval packages) and in the literature when eventually published.
bCOA of interest not included in label.
BPRSd: Brief Psychiatric Rating Scale derived from the PANSS; CGI-I: Clinical Global Impressions Scale-Improvement; CGI-S: Clinical Global Impressions Scale-Severity; COA: clinical outcome assessment; EMA: European Medicines Agency; FDA: United States Food and Drug Administration; PANSS: Positive and Negative Syndrome Scale; PSP: Personal and Social Performance Scale