FDA OKs 3-Month Paliperidone (Invega Trinza) for Schizophrenia

The US Food and Drug Administration (FDA) has approved a quarterly injection form of paliperidone (Invega Trinza, Janssen Pharmaceuticals) for schizophrenia, the company announced today.

Janssen Pharmaceuticals already markets a once-a-day tablet version of paliperidone (Invega) as well as a monthly intramuscular injection version (Invega Sustenna) for schizophrenia. Before patients begin quarterly intramuscular injections of paliperidone, they must first receive the monthly injections for at least 4 months, according to a company news release.

The new drug provides the longest dosing interval available for patients with schizophrenia, enabling them to focus more on their overall recovery and less on taking their medication regularly, the company said.

In a randomized clinical trial described in JAMA Psychiatry last month, 3-month paliperidone reduced the risk for relapse in patients with schizophrenia compared with a placebo without an increase in adverse events. The drug's safety and tolerability profile resembled that of the other versions of paliperidone. Nasopharyngitis, increased weight, headache, and akathisia were among the most commonly reported adverse events.

The labels for both the tablet and monthly-injection versions of paliperidone state in a boxed warning that they are not approved for patients with dementia-related psychosis, and that antipsychotic drugs increase the risk for death in elderly patients with this condition. These warnings also apply to 3-month paliperidone.

The FDA approved 3-month paliperidone under its priority review process, a fast track for drugs thought to represent a significant advance in medical care.

Janssen Pharmaceuticals expects that the new version of paliperidone will be in pharmacies by mid-June.

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