2022-09-13| Trials & Approvals

Otsuka and Lundbeck’s Treatment for Schizophrenia and Bipolar I NDA Accepted by the FDA

by Max Heirich
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On September 13, Otsuka Pharmaceutical and Lundbeck announced the United States Food and Drug administration’s (FDA) acceptance of their New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable. Aripiprazole is a treatment for schizophrenia and a maintenance monotherapy therapy for bipolar I.  

Related Article: Karuna Therapeutics Announces Topline Results from Schizophrenia Therapy Clinical Trial

A Treatment for Schizophrenia and Bipolar I

Schizophrenia is a lifelong mental illness wherein patients interpret reality differently. Patients diagnosed with the disease often experience delusions, hallucinations, and disordered thinking. The combination of these symptoms can impair daily life to the point where the patient cannot function independently.

According to the World Health Organization (WHO), schizophrenia affects 24 million people (1 in 300) worldwide. The primary treatment of schizophrenia is medication, with antipsychotics being the most commonly prescribed. An example of this is Vraylar (cariprazine), a second-generation antipsychotic. This class of drugs causes less serious side effects than the first generation, and Abilify specifically treats multiple mood disorders, like bipolar.

Bipolar is a mental disorder characterized by episodes of mania and depression. A subtype of the disorder wherein the patient experiences more severe instances of these episodes is known as Bipolar I. These recurrent episodes can last weeks or months. Similar to schizophrenia, bipolar I treatment involved the use of antipsychotics. 

Another second-generation antipsychotic is aripiprazole 2-month, ready-to-use long-acting injectable. Long-acting-injectables are a strategy for administering antipsychotics as often patients lapse in administration due to negative side effects or disbelief in the illness. Intended for use every two months, a clinical study compared this version of aripiprazole to aripiprazole once-monthly 400 mg over a two-month dosing interval.

The Clinical Trial Back the NDA

The Clinical Trial 031-201-00181 enrolled 266 patients, testing the effects of aripiprazole 2-month, ready-to-use long-acting injectable. The study met its primary endpoint: establishing a profile similar to the once-monthly 400 mg. In addition, the new delivery method showed no new safety concerns. 

On the trial, Johan Luthman, executive vice president of Lundbeck Research & Development, said, “The trial results reinforce the long-standing efficacy and safety profile of the once-monthly aripiprazole long-acting injectable.”

The trial’s results formed the basis for the companies’ submission to the FDA. The FDA will now review the safety and efficacy of aripiprazole 2-month, ready-to-use, long-acting injectable. If the FDA finds that the drug meets its requirements, they will approve it for US commercialization. 

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