FDA Clears Two Schizophrenia Meds

Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment, most commonly due to suboptimal adherence to treatment with oral antipsychotics.

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The FDA has approved two new medications to treat schizophrenia, including one that is also a treatment for bipolar disorder.

The FDA cleared Teva Pharmaceuticalsand MedinCell’s Uzedy (risperidone) extended-release injectable suspension, the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone, the pharma makers said.

Therapeutic blood concentrations are reached within 6 to 24 hours of a single dose.

Uzedy’s wholesale acquisition cost (WAC) ranges from $1,232 to $3,080 per month depending on dosage strength. Actual costs for individual patients are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply, Teva and MedinCell said.

Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment, most commonly due to suboptimal adherence to treatment with oral antipsychotics, the pharma makers said. "Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.”

“Uzedy embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse,” said Richard Francis, President and CEO of Teva.

Additionally, the FDA approved Otsuka America Pharmaceutical and Lundbeck’s new drug application (NDA) for Alify Asimtufii (aripiprazole) for both schizophrenia and maintenance monotherapy treatment of bipolar I disorder in adults. The extended-release injectable suspension is used once every two months, the pharmaceutical manufacturers said.

The long-acting injectable provides continuous delivery of medication and can maintain therapeutic plasma concentrations, which may help those living with schizophrenia and bipolar I disorder, the companies said.

“This approval is important news for patients, families, and healthcare providers. We hope that the use of Abilify Asimtufii in treatment plans will have a positive impact on those living with schizophrenia or bipolar I disorder,” said Johan Luthman, executive vice president of R&D for Lundbeck.

The medication includes a boxed warning noting that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death and that it is not approved for the treatment of patients with dementia-related psychosis. Abilify Asimtufii is contraindicated with a known hypersensitivity reaction to aripiprazole.

The aripiprazole concentrations of Abilify Asimtufii were explored in a pharmacokinetic bridging study which was a 32-week, open-label, multiple-dose, randomized, parallel-arm, multicenter study in patients living with schizophrenia and bipolar I disorder, according to Otsuka and Lundbeck.

The companies did not respond to Formulary Watch’s requests for comment.