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Also known as Risperidone Long Acting Injectable (LAI)
Risperidone long acting injectable · 7 trials · 4 indications
Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) \>12 or Montgomery-Åsberg Depression Rating Scale (MADRS) \>12 combined with Clinical Global Impression - Severity (CGI-S) \>=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.
Maintenance= Symptom severity assessed with PANSS scale vs baseline (Total, positive, negative, general psychopathology and cognitive cluster score); Remission= percentage of patients with 8 specific items PANSS simultaneously scoring \<= 3 for at least 6 months
Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Risperidone Long Acting Injectable (LAI) Intramuscular injections of risperidone LAI (25 37.5 or 50 mg) every 2 weeks and oral placebo daily |
| 002 | PLACEBO_COMPARATOR | Placebo Intramuscular injections of placebo every 2 weeks and oral placebo daily |
| 003 | ACTIVE_COMPARATOR | Olanzapine Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily |
| Risperidone Long-acting Injectable (LAI) | EXPERIMENTAL | Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg. |
| Name | Type | Description |
|---|---|---|
| Olanzapine | DRUG | Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily |
| Placebo | DRUG | Intramuscular injections of placebo every 2 weeks and oral placebo daily |
| Risperidone Long Acting Injectable (LAI) | DRUG | Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily |
| Risperidone long-acting injectable | DRUG | - |
| Risperidone Long-acting Injectable (LAI) 25 mg | DRUG | Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. |
| Risperidone LAI 37.5 mg | DRUG | Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. |
| Risperidone LAI 50 mg | DRUG | Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks. |
| Aripiprazole | DRUG | 10-30 mg oral once daily for 104 weeks |
| Quetiapine | DRUG | Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg. |
| Risperidone Long acting injectable | DRUG | - |
Inclusion Criteria: * Diagnosis of bipolar I disorder as defined by DSM-IV-TR criteria. All diagnoses will be confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.). Patients who present with additional signs or symptoms compatible with Axis I diagnoses of social anxiety disorder...
Top 10 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Xanomeline and trospium chloride, Xanomeline/Trospium Chloride |
| AbbVie, Inc. | ABBV | 3 | PHASE3 | Cariprazine, ABBV-932, Icalcaprant |
| Xenon Pharmaceuticals Inc. | XENE | 2 | PHASE3 | Azetukalner |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Rapport Therapeutics, Inc. | RAPP | 1 | PHASE2 | RAP-219 |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE2 | NBI-1117568 |
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-100 |
| LB Pharmaceuticals, Inc. | LBRX | 1 | PHASE2 | LB-102 |
| BioXcel Therapeutics, Inc. | BTAI | 1 | PHASE1 | BXCL501 |
| Alzamend Neuro, Inc. | ALZN | 1 | PHASE1 | AL001 |
Risperidone long acting injectable is a small molecule antipsychotic developed by Johnson & Johnson (ticker JNJ) for the treatment of schizophrenia and bipolar disorder. It is given as an intramuscular injection to provide sustained risperidone exposure over an extended dosing interval rather than daily oral dosing.
Risperidone long acting injectable is used for schizophrenia and bipolar disorder. Clinical trials have studied it in schizophrenia, schizoaffective disorder, and maintenance of efficacy in patients with schizophrenia or schizoaffective disorder, including comparisons of gluteal and deltoid intramuscular injection sites.
Risperidone long acting injectable targets HTR2A, HTR2C, and DRD2. It acts as an antagonist at these serotonin 5-HT2A, 5-HT2C, and dopamine D2 receptors, which underlies its antipsychotic activity in schizophrenia and bipolar disorder.
Johnson & Johnson, which trades under the ticker JNJ, develops risperidone long acting injectable. The company is the sponsor behind the clinical development program for this long-acting injectable formulation.
Risperidone long acting injectable is in Phase 3 development. It is an investigational long-acting injectable formulation studied in placebo-controlled, randomized, double-blind trials, and it has not been established as approved based on the development information available.
Completed trials include NCT01888107, a Phase 3 maintenance-of-efficacy study in schizophrenia or schizoaffective disorder with 347 patients, NCT00843687, a Phase 3 pharmacokinetic and safety comparison of gluteal versus deltoid injection sites, NCT00828958, a Phase 3 deltoid injection site tolerability study, and NCT00653406, a Phase 1 pharmacokinetic and safety study.
Yes. Risperidone long acting injectable is also known as risperidone long-acting injectable, risperidone LAI, and risperidone long-acting injectable 25 mg. These names refer to the same long-acting injectable risperidone product developed by Johnson & Johnson.