Aristada LAI 6-Week (aripiprazole lauroxil 6 week formulation) / Alkermes - LARVOL DELTA

Aripiprazole Lauroxil: Development and Evidence-Based Review of a Long-Acting Injectable Atypical Antipsychotic for the Treatment of Schizophrenia. (PubMed, Neuropsychiatr Dis Treat) - "In short-term and long-term studies, AL was generally well tolerated at initiation and during acute and maintenance treatment. Pharmacokinetic, efficacy, and safety characteristics support the use of AL across inpatient and outpatient treatment settings."

Journal • Review • CNS Disorders • Psychiatry • Schizophrenia

Key Characteristics of the Long-Acting Injectable Atypical Antipsychotic Aripiprazole Lauroxil for the Treatment of Adults with Schizophrenia (ASCP 2024) - "2) At the conclusion of this presentation, attendees will be able to describe the short-term and long-term efficacy and safety findings from aripiprazole lauroxil phase 3 clinical trials. 1"

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis. (PubMed, Innov Clin Neurosci) - P4 | "Clinically stable adults with residual symptoms of schizophrenia or intolerance following three or more doses of paliperidone palmitate or risperidone LAI were switched to flexibly dosed open-label AL treatment (441mg, 662mg, or 882mg every 4 weeks or 882mg every 6 weeks) for six months (ClinicalTrials.gov identifier: NCT02634320)...In clinically stable patients with schizophrenia who initiated AL, self-reported functioning was maintained over six months of treatment. Clinician-, caregiver-, and patient-reported cognitive function was stable at baseline and maintained in all NY-AACENT domains; patient-clinician agreement on level of cognitive impairment increased over six months of treatment with AL."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

APPRAISE: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (clinicaltrials.gov) - P4 | N=20 | Terminated | Sponsor: University of California, Los Angeles | N=128 ➔ 20 | Trial completion date: Jun 2025 ➔ Oct 2022 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Oct 2022; Withdraw of financial support by industry collaborator

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Depression • Psychiatry • Schizophrenia • Schizophreniform Disorder

Aripiprazole Lauroxil, a Novel Injectable Long-Acting Antipsychotic Treatment for Adults with Schizophrenia: A Comprehensive Review. (PubMed, Neurol Int) - "Schizophrenia is a severe psychiatric disorder if left untreated. There are multiple medications to help treat schizophrenia. One antipsychotic agent, aripiprazole lauroxil, offers long duration injections that optimize and improve compliance. 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."

Clinical • Journal • Review • CNS Disorders • Hypotension • Mental Retardation • Movement Disorders • Psychiatry • Schizophrenia

Alkermes to Showcase Data From Psychiatry Portfolio at Upcoming Scientific Conferences Throughout Mental Health Awareness Month (PRNewswire) - "Alkermes plc...today announced plans to present clinical data and outcomes research from its psychiatry portfolio at three scientific conferences during Mental Health Awareness Month in May. The meetings, all held virtually, include: American Psychiatric Association (APA) Annual Meeting, May 1-3; International Society for Bipolar Disorders (ISBD) Annual Conference, May 13-15; International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting, May 17-20."

Retrospective data • Review • CNS Disorders • Schizophrenia

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2020 and Provides Financial Expectations for 2021 (PRNewswire) - "Net sales of ARISTADA® were $241.0 million, compared to $189.1 million in the prior year, representing an increase of approximately 27%. Manufacturing and royalty revenues for the year were $484.0 million, compared to $447.9 million in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $345.6 million, compared to $323.3 million in the prior year."

Commercial • Sales • CNS Disorders • Schizophrenia

ALKERMES PLC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) (Market Screener) - "In October 2020, U.S. Patent No. 10,813,928 relating to ARISTADA was granted. The patent has claims to methods of treatment by rapid and continuous intramuscular injection and expires in 2035."

Patent • CNS Disorders • Schizophrenia

Effects of aripiprazole long-acting injectable antipsychotic on hospitalization in recent-onset schizophrenia. (PubMed, Hum Psychopharmacol) - "Results suggest that ALAI is an important therapeutic option in patients with ROS. It leads to reduced usage of hospital services, potentially reducing the socio-economic healthcare burden."

Clinical • Journal • CNS Disorders • Psychiatry • Schizophrenia

A safety evaluation of aripiprazole in the treatment of schizophrenia. (PubMed, Expert Opin Drug Saf) - "Uniquely, aripiprazole treatment is associated with reduced serum prolactin levels and QT interval. A variety of LAI options with dosing intervals as infrequent as every 8 weeks provide a compelling reason to select aripiprazole in patients with limited oral treatment adherence."

Clinical • Journal • CNS Disorders • Movement Disorders • Psychiatry • Schizophrenia

Alkermes plc Reports Third Quarter 2020 Financial Results and Raises 2020 Financial Expectations (PRNewswire) - "Net sales of VIVITROL were $80.3 million, compared to $85.2 million for the same period in the prior year, representing a decrease of 6%,...Net sales of ARISTADA were $62.4 million, compared to $53.6 million for the same period in the prior year, representing an increase of 16%, driven primarily by continued growth of the ARISTADA provider base and growth of the ARISTADA two-month dose. Manufacturing and royalty revenues were $120.4 million, compared to $103.8 million for the same period in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $87.9 million, compared to $76.7 million for the same period in the prior year, primarily driven by an increase in royalty revenue from INVEGA SUSTENNA and the timing of manufacturing shipments of RISPERDAL CONSTA."

Commercial • Sales • CNS Disorders • Schizophrenia

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, CNS Drugs) - 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."

Clinical • Journal • P1 data • PK/PD data • CNS Disorders • Dystonia • Movement Disorders • Pain • Psychiatry • Schizophrenia

[VIRTUAL] Efficacy of the New Formulations of Atypical Antipsychotics in Patients with Chronic Schizophrenia (EPA 2020) - " Pharmacological properties of risperidone microspheres, paliperidone palmitate 1-month and paliperidone palmitate 3-month administered formulations, olanzapine pamoate, aripiprazole monohydrate and aripiprazole lauroxil were analysed and specific properties were underlined... A relatively wide range of long acting injectable atypical antipsychotics is available, therefore choosing between them in clinical practice should be based on a careful analysis of drugs’ specific farmacological properties."

Clinical

Alkermes Plc reports financial results for the fourth quarter and year ended Dec. 31, 2019 and provides financial expectations for 2020 (PRNewswire) - "Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $79.1 million, compared to $81.4 million for the same period in the prior year....Total revenues increased 7% to $1.17 billion in 2019, which included VIVITROL net sales of $335.4 million, ARISTADA net sales of $189.1 million..."

Commercial • Sales

APPRAISE: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (clinicaltrials.gov) - P4; N=128; Recruiting; Sponsor: University of California, Los Angeles

New P4 trial

Alkermes Plc reports third quarter 2019 financial results and implementation of restructuring (PRNewswire) - "Net sales of ARISTADA were $53.6 million, compared to $36.1 million for the same period in the prior year, representing an increase of approximately 48%. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $76.7 million, compared to $77.2 million for the same period in the prior year, reflecting lower manufacturing revenues from RISPERDAL CONSTA."

Sales

Size matters: the importance of particle size in a newly developed injectable formulation for the treatment of schizophrenia. (PubMed, CNS Spectr) - "...A 1-day AL initiation regimen using a NanoCrystal® Dispersion formulation of AL (ALNCD; Aristada Initio®) combined with a single 30 mg dose of oral aripiprazole has been developed as an alternative approach...Safety and tolerability of the 1-day regimen were consistent with the known profile of aripiprazole. Each part of the 1-day initiation regimen, together with AL, is necessary for continuous aripiprazole exposure from treatment initiation until the next regularly scheduled AL injection is administered."

Journal

75 Formulation Properties of Long-acting Injectable Antipsychotics and the Impact on Administration: Focus on Aripiprazole Lauroxil. (PubMed, CNS Spectr) - "...Beyond this common element, formulation properties lead to differences in administration for each of the available LAIs.We reviewed the formulations of LAIs indicated for the treatment of schizophrenia and how they impact instructions for use, with a focus on aripiprazole lauroxil.Aripiprazole monohydrate and olanzapine pamoate are lyophilized powders that require reconstitution before administration and should be injected slowly. Risperidone is formulated as microspheres in powder form that require reconstitution before injection, although the injection speed is not specified...Because the suspension is shear-thinning, aripiprazole lauroxil requires rapid injection, which is not required when using other LAIs. An understanding of the differences in formulation design and how they impact the specific techniques associated with an LAI is essential for successful administration.Funding Acknowledgements: This study was funded by Alkermes, Inc."

Journal

Alkermes Plc reports financial results for the year ended Dec. 31, 2018 and provides financial expectations for 2019 (Alkermes Press Release) - "Net sales of ARISTADA were $48.8 million, compared to $28.3 million for the same period in the prior year, representing an increase of approximately 72%. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $81.4 million, compared to $78.2 million for the same period in the prior year."

Commercial • Sales