Dosage breakthrough for schizophrenia drug, plus 5 more FDA approvals

Posted on October 11, 2016 by ECR Louisville in Blog

FDA has approved the first and only 4-times-per-year schizophrenia drug.

Three-month paliperidone palmitate (Invega Trinza, Janssen Pharmaceuticals) injection, atypical antipsychotic was approved under priority review. Before starting Invega Trinza, patients must be adequately treated with 1-month paliperidone palmitate (Invega Sustenna) for at least 4 months.

Schizophrenia affects approximately 2.4 million adults and is a complex and chronic brain disorder in which symptoms can be severe and disabling and can affect all aspects of a person’s daily life. The course of schizophrenia is varied, frequently involving periodic relapses of the disease with sometimes incomplete response to treatment. Each relapse can result in reduced response to treatment, putting continued symptom control even further out of reach.

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In a long-term maintenance trial, 93% of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. The results of the phase 3 study were published in March by JAMA Psychiatry. Based on positive efficacy, Janssen concluded this study early following the recommendation of an Independent Data Monitoring Committee (IDMC).

“While there is no cure for schizophrenia Invega Trinza  may allow people living with this condition and their treatment teams to spend more time focusing on aspects of their treatment plan such as recovery progress and less time having medication conversations,” said Robyn Frenze, Janssen spokesperson.With this new treatment option, healthcare providers can also give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan.”

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For most people with schizophrenia, the clinical course of the disease is defined by periods of stabilization and relapse; 75% of people with schizophrenia will have a relapse.

“Treatment-related issues, such as adherence problems and treatment interruption/delay, have been identified as potential drivers of relapse,” said Frenze. “With long-acting therapy that is professionally administered, healthcare provdiers can know that medication is on board when patients receive their medication as scheduled.”

Relapse of schizophrenia symptoms, which can result from poor adherence to otherwise effective antipsychotic medication, may lead to treatment resistance, she said. Patients with schizophrenia commonly lack insight into their disease and the importance of medication, compromising treatment adherence.

“Professionally administered long-acting injectable antipsychotic treatments eliminate the need for daily dosing, thus helping to address the problem of nonadherence with daily medications,” Frenze said.

Mental health recovery is an ongoing process, not a single outcome. Each person’s recovery experience is unique. The recovery process can include treatment such as counseling and rehabilitation therapy. These programs, combined with medication, may help delay time to relapse. By following a treatment plan and taking medicine as prescribed, people living with schizophrenia can work toward the recovery process.

Once available, the list price of Invega Trinza will be at parity to that of Invega Sustenna monthly treatment. It is anticipated that Invega Trinza will be commercially available by mid-June.

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 Boehringer Ingelheim

June 02, 2015
http://formularyjournal.modernmedicine.com/formulary-journal/news/dosage-breakthrough-schizophrenia-drug-plus-5-more-fda-approvals