Aristada two-month (aripiprazole lauroxil XR) / Alkermes - LARVOL DELTA

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

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, J Clin Psychiatry) - 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."

Clinical • Journal • Retrospective data • Anesthesia • CNS Disorders • Hypotension • Psychiatry • Schizophrenia • Suicidal Ideation

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, Expert Rev Neurother) - "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)."

Journal • Monotherapy • Review • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Aripiprazole Lauroxil 2-Month Formulation for Acute Schizophrenia: A Post Hoc Analysis of Panss Five-Factor Scores in the Alpine Study (ACNP 2023) - P3b | "In patients with schizophrenia treated with AL 1064 mg every 2 months or PP 156 mg monthly, PANSS five-factor scores improved over time, consistent with previously reported changes in PANSS total score."

Retrospective data • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress (PRNewswire) - "Alkermes plc...announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville."

Clinical data • Observational data • Real-world evidence • Retrospective data • Bipolar Disorder • CNS Disorders • Schizophrenia • Schizophreniform Disorder

Long-Acting Injectable Antipsychotic Adherence Among Texas Medicaid Enrollees with Schizophrenia (ISPOR 2023) - "Mean PDC was highest for paliperidone palmitate 3-month (PP3M)(0.91±0.20), followed by aripiprazole lauroxil 2-month (0.69±0.34), risperidone 4-week (0.64±0.34), aripiprazole monohydrate once monthly (0.63±0.33), paliperidone palmitate once monthly (PP1M) (0.62±0.33), and aripiprazole lauroxil once monthly (0.57±0.33). While results of previous research were inconclusive, this large observational real-world study showed that 3-month administration frequency was superior regarding LAI SGA adherence. There were no significant differences regarding 1- or 2-month administration frequencies."

Adherence • Medicaid • Reimbursement • US reimbursement • CNS Disorders • Psychiatry • Schizophrenia

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, BMC Psychiatry) - P3b | "ALPINE patients initiating the 2-month AL formulation using the 1-day initiation regimen as inpatients and continuing outpatient care experienced schizophrenia symptom improvement, sustained patient satisfaction with medication, stable quality of life, and reduced caregiver burden. 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."

Clinical • Journal • Patient reported outcomes • CNS Disorders • Psychiatry • Schizophrenia

Alkermes plc Reports Second Quarter 2021 Financial Results (PRNewswire) - "Net sales of ARISTADA were $72.4 million, compared to $58.8 million for the same period in the prior year, representing an increase of approximately 23%. Manufacturing and royalty revenues for the quarter were $142.3 million, compared to $116.5 million for the same period in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $95.5 million, compared to $83.1 million for the same period in the prior year."

Commercial • Sales • CNS Disorders • Schizophrenia

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

Safety and Tolerability of Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Treatment of Schizophrenia in the ALPINE Study. (PubMed, CNS Spectr) - "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."

Clinical • Journal • Anesthesia • CNS Disorders • Dystonia • Hypotension • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia • Suicidal Ideation

Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Acute Schizophrenia: ALPINE Exploratory Efficacy and Patient-Reported Outcomes. (PubMed, CNS Spectr) - "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."

Clinical • Journal • Patient reported outcomes • CNS 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

[VIRTUAL] Breakthrough Manic Symptoms Upon Changing Injection Site of a Long-Acting Injectable Antipsychotic: A Case Study (APA 2021) - "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."

Clinical • Bipolar Disorder • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

Aristada: Expiry of patents in US in 2030, 2032, 2033 and 2035 (Alkermes) - Annual Report 2020

Patent • 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

Association between discontinuation due to withdrawal of consent and use of long-acting injectable antipsychotics: A meta-analysis of randomized trials for schizophrenia. (PubMed, J Psychiatr Res) - "The average DWC of each LAI-AP was as follows: LAI-aripiprazole = 10.98%, LAI-fluphenazine = 7.65%, LAI-flupenthixol = 3.33%, LAI-haloperidol = 6.71%, LAI-olanzapine = 10.50%, LAI-paliperidone = 10.38%, LAI-perphenazine = 7.06%, LAI-risperidone = 10.39%, LAI-zuclopenthixol = 4.45%, pooled LAI-APs = 9.88%, and placebo = 11.17%. LAI-AP use was unlikely to be associated with DWC. Although the LAI-aripiprazole had a higher DWC than did the placebo, its average DWC was similar to other those of LAI-APs."

Journal • Retrospective data • CNS Disorders • Psychiatry • 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

Alkermes Presents New Psychiatry Data at Psych Congress 2020 Virtual Experience (PRNewswire) - "Alkermes plc...today announced the presentation of new real-world outcomes research and clinical data related to its psychiatry portfolio at the Psych Congress 2020 Virtual Experience, held Sept. 10-13, 2020. The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder....In addition to the outcomes data, Alkermes presented several posters related to the company's psychiatry products and development candidates, ARISTADA® (aripiprazole lauroxil), ARISTADA INITIO® (aripiprazole lauroxil) and ALKS 3831 (olanzapine/samidorphan)."

Clinical data • P3 data • Retrospective data • CNS Disorders • Schizophrenia

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, J Clin Psychiatry) - P3b | "AL and PP were efficacious and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing outpatient treatment."

Clinical • Journal • P3 data • CNS Disorders • Pain • Schizophrenia

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (clinicaltrials.gov) - P1b; N=266; Completed; Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Apr 2021 ➔ Jul 2020; Trial primary completion date: Apr 2021 ➔ Jul 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Schizophrenia

Alkermes plc Reports Second Quarter 2020 Financial Results and Issues 2020 Financial Expectations (PRNewswire) - "Net sales of ARISTADA were $58.8 million, compared to $48.4 million for the same period in the prior year, representing an increase of approximately 21%...Manufacturing and royalty revenues were $116.5 million, compared to $127.9 million for the same period in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $83.1 million, compared to $91.9 million for the same period in the prior year, primarily driven by a decrease in manufacturing and royalty revenues related to 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