Aristada once-monthly (aripiprazole lauroxil once-monthly 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

Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. (PubMed, J Clin Psychiatry) - P3, P3b | "Objective: Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic, has 2 initiation options: 1-day (AL NanoCrystal Dispersion [ALNCD] injection plus 30 mg oral aripiprazole on day 1 only) and 21-day (15 mg oral aripiprazole for 21 days)...Engaging patients in discussions regarding options for initiating AL may help facilitate shared decision-making and personalization of treatment for patients with schizophrenia. Trial Registration: ClinicalTrials.gov identifiers: NCT03345979 and NCT01469039."

Clinical • Journal • Retrospective data • 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

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

Initiation of Aripiprazole Lauroxil Long-Acting Injectable in Adolescents During Hospitalization: A Case Series. (PubMed, J Child Adolesc Psychopharmacol) - "Our study illustrates that AL LAI may hold potential as an acceptably tolerated treatment in adolescents with varying psychiatric diagnoses. Further studies are needed to evaluate long-term safety and effectiveness of AL LAI in youth."

Journal • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Pain • Pediatrics • Psychiatry • Schizophrenia

Switching to Long-Acting Injectable Antipsychotics: Pharmacological considerations and practical approaches. (PubMed, Expert Opin Pharmacother) - "Recent improvements include a one-day initiation option for aripiprazole lauroxil, aripiprazole once-monthly, risperidone in situ microparticles and subcutaneous risperidone. Future LAI developments should focus on longer dosing intervals, subcutaneous administration, expansion of LAIs beyond currently available antipsychotic agents and indications beyond schizophrenia and bipolar disorder. In the future, LAIs might become a first-line treatment after initial oral stabilization for chronic mental disorders with need for maintenance treatment and presence of significant non-adherence."

Journal • Review • Bipolar Disorder • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Aripiprazole: Examining the Clinical Implications of D2 Affinity (APA 2023) - "She historically has had good response to oral and long-acting formulations of Risperidone and Paliperidone...Those that have proposed mechanisms typically refer to Aripiprazole’s partial agonist activity as the causative factor, rather than an impediment to antipsychotic binding which we have described. Prescribers should be aware of this potential interaction and carefully consider initiating long-acting injectable forms of Aripiprazole to avoid this phenomenon."

Clinical • CNS Disorders • Psychiatry • Schizophrenia • DRD2

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

Long-Term Safety and Symptom Trajectory with Aripiprazole Lauroxil in Female Patients with Schizophrenia: A Post Hoc Subgroup Analysis (ASCP 2023) - P3 | "Long-term treatment with AL was safe and effective in females with schizophrenia. Symptom trajectory and safety outcomes in females by age and illness severity were consistent with the overall study population results. Learning Objectives 1."

Clinical • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Long-Term Health Outcomes in Patients with Schizophrenia Treated with the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil for 1 Year (ISPOR 2022) - P3 | "The majority of patients with stable schizophrenia reported “no problems” or “slight problems” over 5 health outcome dimensions after 1 month of OLE treatment with AL. The proportion of patients with “no problems” or “slight problems” was even greater after 1 year of AL treatment, indicating that long-term consistent treatment is associated with improvements in self-reported health-related quality of life."

Clinical • HEOR • CNS Disorders • Depression • Mood Disorders • Pain • Psychiatry • Schizophrenia

Long-Term Health Outcomes in Patients With Schizophrenia Treated With the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil for 1 Year (ACNP 2022) - P3 | "The majority of patients with stable schizophrenia reported “no problems” or “slight problems” over 5 health outcome dimensions after 1 month of OLE treatment with AL. The proportion of patients with “no problems” or “slight problems” was even greater after 1 year of AL treatment, indicating that long-term consistent treatment is associated with improvements in self-reported health-related quality of life."

Clinical • HEOR • CNS Disorders • Depression • Mood Disorders • Pain • 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

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

Alkermes plc Reports First Quarter 2021 Financial Results (PRNewswire) - "Total revenues for the quarter were $251.4 million....Net sales of ARISTADA were $55.4 million, compared to $51.0 million for the same period in the prior year, representing an increase of approximately 9%....'Coupled with expected growth of our commercial portfolio, including the potential launch of LYBALVI™ and growth of VUMERITY®, and a focus on efficiency, cost management and strong governance, we have the potential to drive significant growth and value creation in 2021 and beyond.'"

Launch US • Sales • CNS Disorders • Schizophrenia

Aripiprazole IM depot as an option for the treatment of bipolar disorder. (PubMed, Expert Opin Pharmacother) - "No studies are expected or planned in the near future. Aripiprazole lauroxil has not applied for approval in bipolar disorder and there is no sign it will."

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

[VIRTUAL] Handwriting Kinematics in Schizophrenia Patients Treated with Long-Acting Injectable Atypical Antipsychotics: Results from the ALPINE Study (SIRS 2021) - "Discussion In this exploratory analysis, ALPINE study participants who achieved PANSS or CGI-S response after 4 weeks of LAI treatment had lower movement velocities and a greater %NBM in HWK tasks at baseline than those who did not. This pattern suggests that baseline HWKs may reflect striatal dopamine dysfunction and could be a useful predictor of antipsychotic therapeutic response at 4 weeks of treatment."

Clinical • CNS Disorders • Schizophrenia

[VIRTUAL] Handwriting Kinematics in Schizophrenia Patients Treated with Long-Acting Injectable Atypical Antipsychotics: Results from the ALPINE Study (SIRS 2021) - "Discussion In this exploratory analysis, ALPINE study participants who achieved PANSS or CGI-S response after 4 weeks of LAI treatment had lower movement velocities and a greater %NBM in HWK tasks at baseline than those who did not. This pattern suggests that baseline HWKs may reflect striatal dopamine dysfunction and could be a useful predictor of antipsychotic therapeutic response at 4 weeks of treatment."

Clinical • CNS Disorders • Schizophrenia

Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. (PubMed, BMC Psychiatry) - P3 | "In this post hoc analysis, outpatients with schizophrenia who continued the LAI antipsychotic AL showed gradual and sustained improvement in self-reported mental HRQoL over several years of follow-up, whereas self-reported physical HRQoL did not change. By the end of follow-up, mental health scores of study patients with schizophrenia were comparable to those of the general population and better than those of patients with depression."

Clinical • HEOR • Journal • CNS Disorders • Depression • Diabetes • Hypertension • Metabolic Disorders • Psychiatry • Schizophrenia • Type 2 Diabetes Mellitus

Long-acting injectable antipsychotics: what, when, and how. (PubMed, CNS Spectr) - "Available LAI formulations in the United States include first-generation antipsychotics (fluphenazine decanoate and haloperidol decanoate), risperidone/paliperidone containing products (risperidone microspheres, paliperidone palmitate, and risperidone subcutaneous), aripiprazole containing products (aripiprazole monohydrate and aripiprazole lauroxil), and olanzapine pamoate...Differences and similarities among the different products are discussed, including guidance regarding optimal treatment selection. Tips are provided to enhance effective patient communication to maximize the likelihood of acceptance of this treatment modality."

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

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