Enforcement Report - Week of May 1, 2024
The European Commission (EC) has approved Otsuka Pharmaceutical Europe and H Lundbeck’s Abilify Maintena 720mg/960mg (aripiprazole) for the maintenance treatment of schizophrenia.
Sunshine Lake Pharma`s Generic Aripiprazole Receives Approval in the U.S.
Friday, the FDA approved Otsuka and Lundbeck’s extended-release injectable formulation of aripiprazole, now to be marketed as Abilify Asimtufii, for the treatment of schizophrenia or as maintenance therapy for bipolar I disorder.
FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults
Enforcement Report - Week of April 26, 2023
Enforcement Report - Week of April 12, 2023
PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd (Otsuka) and H. Lundbeck A/S (Lundbeck) published results from research demonstrating that an investigational long-acting injectable, aripiprazole 2-month, ready-to-use 960 mg, offers comparable tolerability, safety and therapeutic plasma levels as aripiprazole 1-month, ready-to-use 400 mg, currently approved in adult patients for the treatment of schizophrenia or the maintenance treatment of bipolar I disorder (BP-I). The research is published in CNS Drugs. nn“Long-acting injectables are associated with less frequent symptom relapses and hospitalizations in those with complex psychiatric conditions” nnTweet this nThe 32-week randomized trial evaluated the safety, tolerability and pharmacokinetic profile of aripiprazole 2-month compared to aripiprazole 1-month, among 266 eligible patients. Results showed aripiprazole 2-month is a well-tolerated maintenance treatment for schizophrenia and BP-I and maintains consistent therapeutic plasma levels for at least two months as compared to aripiprazole 1-month plasma levels following repeated monthly dosing. nn“Long-acting injectables are associated with less frequent symptom relapses and hospitalizations in those with complex psychiatric conditions,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “The results of this study demonstrate that the extended dosing interval option of aripiprazole could provide clinicians with an effective potential treatment option for patients who may have greater challenges with medication adherence or access to treatment.” nn“We are committed to continued research in new treatment options for patients with mental illness such as schizophrenia and BP-I,” said Johan Luthman, executive vice president, Lundbeck Research & Development. “Long-acting treatment options could better help them manage their symptoms so they can focus on other areas of their lives.” nnThe recently published data regarding aripiprazole 2-month demonstrated consistent safety results with that of aripiprazole 1-month with low rates of discontinuation due to adverse events. The most frequently reported adverse events (>10% in either treatment group) were increased weight gain (22.7% for aripiprazole 2-month versus 20.9% for aripiprazole 1-month) and injection site pain (18.2% for aripiprazole 2-month versus 9.0% for aripiprazole 1-month). Most events of injection site pain coincided with the first injection, resolved within five days and were rated as mild to moderate in severity by the investigators. nnAbout Schizophrenia nnSchizophrenia is a severely debilitating mental illness characterized by delusions, hallucinations, and disordered cognition. Based on a systematic review of global data, the prevalence of schizophrenia in 2019 was estimated to be approximately 0.3% and did not vary widely across countries or regions. The worldwide lifetime prevalence of the disease has been estimated to be approximately 0.9% across diverse geographic, cultural, and socioeconomic categories. The course of schizophrenia is typically characterized by acute episodes of psychotic behaviors occurring at varying intervals between periods of relative symptomatic stability. Medication adherence in patients with schizophrenia is generally poor and several studies have demonstrated that the strongest predictor of further relapse is nonadherence with antipsychotic medications. nnAbout Bipolar I Disorder nnBipolar I disorder is a recurrent, lifelong mood disorder with a variable course that results in functional and cognitive impairment and a reduction in quality of life that affects 0.6% of the population. The course of bipolar I disorder is characterized by recurrent manic and depressive episodes that may last weeks or months. Over 90% of people with bipolar disorder experience recurrences during their lifetime. nnBipolar I disorder often requires long-term pharmacologic treatment to delay time to recurrence or relapse of symptoms. Long-acting injectables provide continuous delivery of antipsychotic medication and maintain therapeutic plasma concentrations, which may help address the variable nature of bipolar disorder. nnAbout aripiprazole 2-month, ready-to-use, long-acting injectable nnAripiprazole 2-month, is an investigational long-acting injectable provided in a single-chamber-type, ready-to-use (RTU) pre-filled syringe that does not require reconstitution, intended for dosing every two months via intramuscular (IM) injection in the gluteal muscle in the same patient populations as indicated for once-monthly ABILIFY MAINTENA® (aripiprazole 1-month). nnResults from the pivotal trial 031-201-00181, that enrolled 266 patients, demonstrated that aripiprazole every two months met the primary endpoint criteria establishing similarity of aripiprazole plasma concentrations and comparable efficacy to aripiprazole once-monthly over a two-month dosing interval. nnMultiple-dose administrations of aripiprazole 2-month were generally well tolerated in subjects with schizophrenia or bipolar I disorder, and did not show any new safety concerns compared to aripiprazole 1-month. nnAripiprazole 2-month, ready-to-use, long-acting injectable has been filed for approval in Europe, Canada and the United States. If approved, aripiprazole 2-month would be the first 2-month, long-acting injectable antipsychotic indicated for both treatment of schizophrenia and the maintenance treatment of bipolar I disorder
Enforcement Report - Week of March 8, 2023
Rubicon's Generic Aripiprazole Receives Approval in the U.S.