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Asenapine WHITE raspberry flavor · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment A, C, B, A, C, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 2 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment A, B, C, A, B, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 3 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment B, C, A, B, C, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 4 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment B, A, C, B, A, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 5 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment C, B, A, C, B, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 6 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment C, A, B, C, A, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Name | Type | Description |
|---|---|---|
| Asenapine WHITE raspberry flavor (Treatment A) | DRUG | Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets |
| Asenapine RED raspberry flavor (Treatment B) | DRUG | Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets |
| Asenapine WHITE UNFLAVORED (Treatment C) | DRUG | Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets |
Inclusion Criteria: * are at least 18 years of age and of legal minimum age for trial participation; * are a male, or a female who is not of childbearing potential * are free from an acute exacerbation of psychosis for at least 3 months; * have a current DSM-IV diagnosis of schizophrenia (paranoid,...
Asenapine WHITE raspberry flavor is a raspberry-flavored oral formulation of asenapine, a small molecule studied in stable patients with a psychotic disorder. It was evaluated in a Phase 2 acceptability study comparing the raspberry flavored version with unflavored asenapine. It is also known as Asenapine WHITE raspberry flavor (Treatment A).
Asenapine WHITE raspberry flavor was studied in patients with psychosis, specifically stable patients with a psychotic disorder. The Phase 2 trial assessed acceptability of the raspberry flavored formulation compared with unflavored asenapine in this patient population. It is an investigational formulation and is not described as approved.
Asenapine WHITE raspberry flavor targets DRD2 and HTR2A, acting as an antagonist at both. DRD2 is the dopamine D2 receptor and HTR2A is the serotonin 5-HT2A receptor. This receptor profile is the basis for its study in psychosis.
Asenapine WHITE raspberry flavor is developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor associated with the clinical development program for this flavored asenapine formulation.
Asenapine WHITE raspberry flavor is in Phase 2 development. The single recorded trial, NCT00878462, is a completed Phase 2 acceptability study. It is an investigational formulation, and the available information does not indicate that it is FDA approved.
Asenapine WHITE raspberry flavor was studied in trial NCT00878462, titled an acceptability study of unflavored asenapine versus raspberry flavored asenapine in stable patients with a psychotic disorder. The Phase 2 trial enrolled 174 patients, was randomized and controlled, and is completed.