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- || Clinical, Retrospective data, Journal: Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial. (Pubmed Central) - Feb 28, 2024
P3b
Results were consistent with known safety profiles of AL and PP and support the safety of AL 1064 mg every 2 months initiated using ALNCD plus 30-mg oral aripiprazole. Trial Registration: ClinicalTrials.gov identifier: NCT03345979.
- || Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Review, Journal, Monotherapy: Evaluating the efficacy and safety of the currently available once-every-two months long-acting injectable formulations of aripiprazole for the treatment of schizophrenia or as a maintenance monotherapy for bipolar I disorder in adults. (Pubmed Central) - Feb 1, 2024
An aripiprazole long-acting injectable (LAI) antipsychotic is now available for gluteal administration every 2?months via two different formulations: aripiprazole lauroxil (AL) and aripiprazole monohydrate (Ari 2MRTU)...Multiple doses of AL 1064?mg or Ari 2MRTU 960?mg are generally well tolerated, in line with the safety profile of oral aripiprazole, with the exception of the injection-site reactions. While AL may require a 1-day initiation regimen, Ari 2MRTU 960 covers all the recommended doses of oral aripiprazole (10-20?mg).
- | Abilify Maintena (aripiprazole extended release) / Otsuka, Lundbeck, Abilify Asimtufii (aripiprazole two-month) / Lundbeck, Otsuka
Phase classification: A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (clinicaltrials.gov) - Nov 18, 2023
P1/2, N=266, Completed, Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
While AL may require a 1-day initiation regimen, Ari 2MRTU 960 covers all the recommended doses of oral aripiprazole (10-20?mg). Phase classification: P1b --> P1/2
- Long-Acting Injectable Antipsychotic Adherence Among Texas Medicaid Enrollees with Schizophrenia () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_226;
Phase classification: P1b --> P1/2 Mean PDC was highest for paliperidone palmitate 3-month (PP3M)(0.91
- | Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada LAI 6-Week (aripiprazole lauroxil 6 week formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Journal: Aripiprazole Lauroxil Dosing Regimens: Understanding Dosage Strengths and Injection Intervals. (Pubmed Central) - May 29, 2022
Mean PDC was highest for paliperidone palmitate 3-month (PP3M)(0.91 No abstract available
- || Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, Journal, Patient reported outcomes: Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Acute Schizophrenia: ALPINE Exploratory Efficacy and Patient-Reported Outcomes. (Pubmed Central) - Dec 30, 2021
No abstract available In ALPINE, patients who initiated AL or PP in the hospital and continued treatment during outpatient care experienced improvement in schizophrenia symptoms and reported satisfaction with medication, decreased caregiver burden, and stable quality of life.
- || Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, Journal, Patient reported outcomes: Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. (Pubmed Central) - Oct 27, 2021
P3b
A similar benefit pattern was observed for PP. These results support the feasibility of starting either long-acting injectable in the hospital and transitioning to outpatient treatment.
- || Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, P1 data, PK/PD data, Journal: Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study. (Pubmed Central) - Oct 22, 2021
P1
AL 1064 mg q8wk provided continuous exposure to aripiprazole throughout the 8-week dosing interval and had a safety profile consistent with the 4- and 6-week regimens. These findings were used to support FDA approval of the 1064-mg dose administered every 2 months.
- || Aristada LAI 6-Week (aripiprazole lauroxil 6 week formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, Review, Journal: Aripiprazole Lauroxil, a Novel Injectable Long-Acting Antipsychotic Treatment for Adults with Schizophrenia: A Comprehensive Review. (Pubmed Central) - Jul 22, 2021
Known side effects include weight gain, akathisia, neuroleptic malignant syndrome, tardive dyskinesia, and orthostatic hypotension. Aripiprazole lauroxil is an FDA-approved drug that can be administered monthly, every six weeks, or every two months and has been shown to be both safe and effective.
- || Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, Journal: Safety and Tolerability of Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Treatment of Schizophrenia in the ALPINE Study. (Pubmed Central) - Jun 16, 2021
No unexpected safety and tolerability findings were identified in patients treated with AL or PP who were hospitalized for acute schizophrenia exacerbation and transitioned to outpatient care in ALPINE. AESI profiles were consistent with each treatment's respective known safety profile.
- Aristada two-month (aripiprazole lauroxil XR) / Alkermes
[VIRTUAL] Breakthrough Manic Symptoms Upon Changing Injection Site of a Long-Acting Injectable Antipsychotic: A Case Study () - May 2, 2021 - Abstract #APA2021APA_288;
Abilify Aristada (aripiprazole lauroxil), on the other hand, has been used off label for the same indication [5]...When her dose was given in the gluteal region in the following month, her symptoms resolved. Such a presentation could warrant studying the difference in pharmacokinetics between the gluteal and deltoid injections of the Aristada 882mg.
- ||| Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, P3 data, Journal: Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. (Pubmed Central) - Sep 16, 2020
P3b
Such a presentation could warrant studying the difference in pharmacokinetics between the gluteal and deltoid injections of the Aristada 882mg. AL and PP were efficacious and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing outpatient treatment.
- ||| Abilify Maintena (aripiprazole extended release) / Otsuka, Lundbeck, Abilify Asimtufii (aripiprazole two-month) / Lundbeck, Otsuka
Trial completion, Trial completion date, Trial primary completion date: A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (clinicaltrials.gov) - Aug 7, 2020
P1b, N=266, Completed, Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
AL and PP were efficacious and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing outpatient treatment. Active, not recruiting --> Completed | Trial completion date: Apr 2021 --> Jul 2020 | Trial primary completion date: Apr 2021 --> Jul 2020
- || Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, Journal: 167 Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil with 1-Day Initiation in Acutely Ill Patients with Schizophrenia. (Pubmed Central) - Apr 28, 2020
Active, not recruiting --> Completed | Trial completion date: Apr 2021 --> Jul 2020 | Trial primary completion date: Apr 2021 --> Jul 2020 AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting.
- Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
[VIRTUAL] Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Acute Schizophrenia: ALPINE Study Exploratory Efficacy and Patient-Reported Outcomes () - Apr 16, 2020 - Abstract #ASCP2020ASCP_103;
Learning Objectives: 1. To understand the results of exploratory efficacy outcomes, including PANSS Positive, Negative, and General subscales, for patients with an acute exacerbation of schizophrenia treated with AL or PP in the ALPINE study 2.
- Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Actigraphic Monitoring of Sleep-Wake Cycle in Schizophrenia Outpatients Receiving a Long-Acting Injectable Antipsychotic: Feasibility and Initial Results from a Prospective RCT (Spadolini - Ground Floor) - Jan 17, 2020 - Abstract #SIRS2020SIRS_511;
Methods Exploratory actigraphy assessments were carried out in a 25-week, prospective, randomized, controlled trial (RCT) primarily designed to evaluate safety and effectiveness of aripiprazole lauroxil (AL) for treatment of schizophrenia (1-day initiation regimen and a 2-month dose interval)...This dataset offers some evidence on the relative stability of SWC for individual patients over time, as well as possible group differences based on demographic, symptom, or treatment factors. Data from this analysis can provide guidance for future actigraphy studies in schizophrenia.
- || Abilify Maintena (aripiprazole extended release) / Otsuka, Lundbeck, Abilify Asimtufii (aripiprazole two-month) / Lundbeck, Otsuka
Enrollment closed: A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (clinicaltrials.gov) - Dec 5, 2019
P1b, N=266, Active, not recruiting, Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Data from this analysis can provide guidance for future actigraphy studies in schizophrenia. Recruiting --> Active, not recruiting
- | Abilify Maintena (aripiprazole extended release) / Otsuka, Lundbeck, Abilify Asimtufii (aripiprazole two-month) / Lundbeck, Otsuka
Enrollment open: A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (clinicaltrials.gov) - Aug 26, 2019
P1b, N=258, Recruiting, Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Abilify Maintena (aripiprazole extended release) / Otsuka, Lundbeck, Abilify Asimtufii (aripiprazole two-month) / Lundbeck, Otsuka
New P1 trial: A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (clinicaltrials.gov) - Jul 22, 2019
P1b, N=258, Not yet recruiting, Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
- | Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada LAI 6-Week (aripiprazole lauroxil 6 week formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Clinical, P1 data, PK/PD data, Journal: A Phase-1 Study Comparing Pharmacokinetic and Safety Profiles of Three Different Dose Intervals of Aripiprazole Lauroxil. (Pubmed Central) - Jun 28, 2019
The results of this study show that 1064 mg AL may be suitable for a 2-month dose interval. The three doses/dose intervals studied have the potential to help clinicians and patients expand their choice of AL treatment to best meet the needs of the individual patient.
- ||||| Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Trial completion, Trial completion date, Trial primary completion date: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia (clinicaltrials.gov) - Apr 12, 2019
P3b, N=200, Completed, Sponsor: Alkermes, Inc.
The three doses/dose intervals studied have the potential to help clinicians and patients expand their choice of AL treatment to best meet the needs of the individual patient. Active, not recruiting --> Completed | Trial completion date: Aug 2019 --> Mar 2019 | Trial primary completion date: Aug 2019 --> Mar 2019
- risperidone / Generic mfg., Egis, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Change in Prolactin and Sexual Side Effects in Patients With Schizophrenia Who Switched From Paliperidone Palmitate or Risperidone Long-Acting Injection to Aripiprazole Lauroxil (Regency S-V) - Apr 3, 2019 - Abstract #SIRS2019SIRS_187;
On average, mean prolactin level normalization occurred within 2 months of AL initiation. Overall, self-reported sexual side effects improved following the switch; the greatest improvement was noted in the domain of sexual interest.
- | Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Enrollment closed: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia (clinicaltrials.gov) - Nov 9, 2018
P3b, N=200, Active, not recruiting, Sponsor: Alkermes, Inc.
Overall, self-reported sexual side effects improved following the switch; the greatest improvement was noted in the domain of sexual interest. Recruiting --> Active, not recruiting
- |||||| Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Enrollment open: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia (clinicaltrials.gov) - Jan 17, 2018
P3b, N=180, Recruiting, Sponsor: Alkermes, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| Aristada two-month (aripiprazole lauroxil XR) / Alkermes
New P3 trial: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia (clinicaltrials.gov) - Nov 17, 2017
P3b, N=180, Not yet recruiting, Sponsor: Alkermes, Inc.
- ||| Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Trial completion, Trial primary completion date: An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia (clinicaltrials.gov) - May 3, 2016
P1, N=140, Completed, Sponsor: Alkermes, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial primary completion date: Jul 2016 --> Apr 2016
- Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Enrollment closed: An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia (clinicaltrials.gov) - Jul 2, 2015
P1, N=140, Active, not recruiting, Sponsor: Alkermes, Inc.
Active, not recruiting --> Completed | Trial primary completion date: Jul 2016 --> Apr 2016 Recruiting --> Active, not recruiting
- Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Enrollment open: An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia (clinicaltrials.gov) - Mar 11, 2015
P1, N=140, Recruiting, Sponsor: Alkermes, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes, Aristada two-month (aripiprazole lauroxil XR) / Alkermes
New P1 trial: An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia (clinicaltrials.gov) - Dec 19, 2014
P1, N=140, Not yet recruiting, Sponsor: Alkermes, Inc.