Approval Probability
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Paliperidone palmitate eq · 1 trial · 1 indication
The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Paliperidone palmitate 25 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8 36 64 |
| 002 | EXPERIMENTAL | Paliperidone palmitate 100 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8 36 64 |
| 003 | EXPERIMENTAL | Paliperidone palmitate 150 mg eq. Paliperidone palmitate 150 mg eq. i.m. Days 1 8 36 64 |
| 004 | PLACEBO_COMPARATOR | Placebo Placebo i.m. Days 1 8 36 64 |
| Name | Type | Description |
|---|---|---|
| Paliperidone palmitate 25 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64 |
| Paliperidone palmitate 150 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64 |
| Placebo | DRUG | Placebo i.m. Days 1, 8, 36, 64 |
| Paliperidone palmitate 100 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64 |
Inclusion Criteria: * Met diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric pro...
Paliperidone palmitate eq is an investigational small molecule being studied for the treatment of schizophrenia. It is a long-acting injectable antipsychotic formulation of paliperidone palmitate, developed by Johnson & Johnson (JNJ). The drug is currently in Phase 3 clinical development for this psychiatric indication.
Paliperidone palmitate eq is an atypical antipsychotic that works by blocking dopamine D2 and serotonin 5-HT2A receptors in the brain. This mechanism helps to reduce the positive and negative symptoms of schizophrenia. The drug is a long-acting injectable formulation designed to provide sustained delivery of paliperidone.
Paliperidone palmitate eq is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's effectiveness and safety in patients with schizophrenia.
Paliperidone palmitate eq is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for the treatment of schizophrenia.
Paliperidone palmitate eq has one completed Phase 3 clinical trial, registered as NCT00590577. This randomized, double-blind, placebo-controlled study evaluated the effectiveness and safety of three fixed doses (25 mg eq., 100 mg eq., and 150 mg eq.) of the drug in 652 patients with schizophrenia across multiple countries.
Paliperidone palmitate eq is a formulation of paliperidone palmitate, which is the active ingredient in the marketed product Invega Sustenna. However, the specific formulation being studied in the Phase 3 trial may differ from the commercially available product. The drug is being developed by Johnson & Johnson for schizophrenia.