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Paliperidone palmitate 3 month formulation · 1 trial · 1 indication
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
| Arm | Type | Description |
|---|---|---|
| Paliperidone palmitate 3 month formulation (PP3M) | EXPERIMENTAL | Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq.) up to 525 mg eq. based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq. |
| Name | Type | Description |
|---|---|---|
| Paliperidone palmitate 3 month formulation (PP3M) | DRUG | Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq) up to 525 mg eq based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq. |
Inclusion Criteria: * Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia * Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the s...
Paliperidone palmitate 3 month formulation is used for the treatment of schizophrenia. It is a long-acting injectable antipsychotic being developed by Johnson & Johnson (JNJ) for patients who have been stabilized on the 1-month formulation. The drug is currently in Phase 3 clinical development.
Paliperidone palmitate 3 month formulation is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with schizophrenia who were previously stabilized on the 1-month formulation.
Paliperidone palmitate 3 month formulation is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 study has been completed to evaluate the transition from the 1-month to the 3-month formulation in patients with schizophrenia.
Paliperidone palmitate 3 month formulation has one completed Phase 3 clinical trial, NCT02713282, which enrolled 306 participants. The study evaluated transitioning patients with schizophrenia who were previously stabilized on the 1-month formulation to the 3-month formulation. The trial was conducted across multiple countries, including the United States and European nations.
Paliperidone palmitate 3 month formulation is a longer-acting version of the 1-month formulation. While both contain the same active ingredient, paliperidone palmitate, the 3-month formulation is designed to be administered every three months instead of monthly. The 3-month formulation is being studied for patients already stabilized on the 1-month formulation.