FDA Approves First Three-Month-Long Injectable Antipsychotic

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FDA Approves First Three-Month-Long Injectable Antipsychotic
FDA Approves First Three-Month-Long Injectable Antipsychotic

The FDA has approved the first three-month, long-acting antipsychotic, Invega Trinza (three month paliperidone palmitate), making it possible that schizophrenia patients could be treated with medication only four times a year.

Given that many schizophrenia patients experience relapse and have trouble staying on medication, the approval of Invega Trinza, manufactured by Janssen Pharmaceuticals, also meets an important, unmet medical need.

However, patients cannot be started on Invega Trinza right away. They first must be put on Invega Sustenna (paliperidone palmitate), a once-monthly injection, for at least four months.

The approval of Invega Trinza was supported by strong results from a long-term maintenance trial, the results of which were published in JAMA Psychiatry in March. The data showed that 93% of patients who took the three-month medication did not experience a relapse while on it.

“With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control,” trial investigator Joseph Kwentus, MD, of Precise Research Centers, Flowood, Miss., said in a statement.

Janssen said it hopes to have Trinza commercially available by mid-June.

For more information, go here.

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