Pharmaceutical

FDA approves new seasonal schizophrenia drug

johnsonandjohnson FDA approves new seasonal schizophrenia drugThe Food and Drug Administration (FDA) has approved a new version of Johnson & Johnson’s schizophrenia treatment Invega that is administered every three months, making it the longest dosing interval available.

The original version of Invega is a tablet administered once daily to treat schizophrenia symptoms in adults and adolescents. It is also used to treat schizoaffective disorder. Another version of the drug, called Invega Sustenna, was introduced in 2009. It is an injectable version that is administered monthly. Invega Trinza is also an injectable drug that is administered just four times a year.

“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,” Joseph Kwentus, MD, trial investigator at Precise Research Centers, said in a statement. “Recovery looks different for everyone, and the long-term symptom control offered by Invega Trinza can help patients work toward their own personal goals.”

Invega drugs contain the active ingredient paliperidone. The medications have been a huge success for Johnson & Johnson, but they have been marked by controversy. In 2013, the drug company admitted to criminal misconduct and agreed to pay $2.2 billion to resolve claims that pharmaceutical salesmen paid kickbacks to doctors and illegally promoted off-label use of three of its drugs including Invega and the company’s other antipsychotic Risperdal.

Earlier this month, the FDA issued Johnson & Johnson a “complete response letter” regarding the company’s supplemental New Drug Application to expand the label of Invega Sustenna to include additional trial data about the longevity of the medication compared to competitive medications. The FDA is requesting more information about the data on the clinical trial.

Sources:
Law 360
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