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...
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PP3M eq is used for the treatment of schizophrenia. It is an investigational long-acting injectable formulation studied in adults 18 years and older with schizophrenia. The clinical program enrolled 1,938 patients across two completed Phase 3 trials, both of which were randomized, double-blind, and placebo-controlled.
PP3M eq is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored both Phase 3 trials of the formulation in schizophrenia, one conducted mainly in the United States and Europe and the other across a broader set of countries including Asia and Latin America.
PP3M eq is in Phase 3 clinical development for schizophrenia. Both of its Phase 3 trials have been completed, and no trials are currently listed as active. It is an investigational product and is not described as approved by the FDA.
PP3M eq has been studied in two completed Phase 3 trials: NCT01529515, which enrolled 509 patients with schizophrenia, and NCT01515423, which enrolled 1,429 patients. Both were randomized, double-blind, and placebo-controlled, and both required participants to be at least 18 years old.
A total of 1,938 patients were enrolled across the two completed Phase 3 trials of PP3M eq. NCT01529515 enrolled 509 participants, and NCT01515423 enrolled 1,429. Both studies were randomized, double-blind, and placebo-controlled and included adults with schizophrenia.