Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PP3M eq · 2 trials · 1 indication
Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (\>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (\<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (\>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was \<=3 at randomization; had a score of \>=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Paliperidone palmitate 3-month (PP3M) | EXPERIMENTAL | A formulation of paliperidone palmitate with a 3-month injection interval |
| Paliperidone palmitate 1-month (PP1M) | ACTIVE_COMPARATOR | A formulation of paliperidone palmitate with a 1-month injection interval |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PP3M 175 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| PP3M 263 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| PP3M 350 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| PP3M 525 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| Placebo (20% Intralipid) | DRUG | Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks. |
| PP1M 50 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| PP1M 75 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| PP1M 100 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| PP1M 150 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| Placebo (20% Intralipid emulsion) | DRUG | Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. |
Inclusion Criteria: * Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator * A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120 * Signed informed consent * Women must not be pregnant, breastfeeding, an...
PP3M eq is an investigational small molecule being developed for the treatment of schizophrenia. It is a long-acting formulation of paliperidone palmitate, designed to be administered every three months. The drug is currently in Phase 3 clinical development and has been studied in two completed trials.
PP3M eq is a long-acting formulation of paliperidone palmitate, which is an atypical antipsychotic. It works by targeting dopamine and serotonin receptors in the brain, specifically acting as an antagonist at D2 and 5-HT2A receptors. This mechanism helps to manage the symptoms of schizophrenia.
PP3M eq is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting Phase 3 clinical trials for this drug in the treatment of schizophrenia.
PP3M eq is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 1,938 participants, but the drug remains in clinical development.
PP3M eq has been studied in two completed Phase 3 clinical trials. The first, NCT01515423, enrolled 1,429 participants with schizophrenia across multiple countries. The second, NCT01529515, enrolled 509 participants. Both trials were randomized, double-blind, and placebo-controlled.
PP3M eq is a long-acting formulation of paliperidone palmitate, specifically designed for administration every three months. While it shares the active ingredient with other paliperidone palmitate products, PP3M eq is a distinct formulation with a longer dosing interval, currently in Phase 3 development for schizophrenia.