FDA Approves Drug for Schizophrenia to be Administered at a Six Month Interval FDA has approved Invega Hafyera (paliperidone palmitate) extended-release injectable suspension to treat schizophrenia in certain adults. Invega Hafyera, an atypical antipsychotic, is the first long-acting schizophrenia medication to be injected once every six months. Schizophrenia is a brain disorder characterized by symptoms including delusions, hallucinations, trouble with thinking, and lack of motivation. Schizophrenia affects less than one percent of the U.S. population. It is a chronic disorder, but symptoms can decrease with treatment. Other long-acting injectable antipsychotics are administered every few weeks to every three months. Invega Hafyera's less frequent dosing intervals may offer more convenience for patients, caregivers, and providers. The efficacy of Hafyera was evaluated in a randomized, double-blind, active-controlled study in 702 adults with schizophrenia who had previously been stably treated with either Invega Sustenna, a one-month extended-release injectable suspension, for at least four months, or Invega Trinza, a one-time three-month extended-release injectable suspension. The study was a non-inferiority trial designed to evaluate whether the time to relapse for Hafyera administered once every six months provided similar effectiveness as Trinza administered every three months. Among the treatment groups, 7.5% of patients in the Hafyera group experienced a relapse whereas 4.9% of patients in the Trinza group experienced a relapse. The difference between groups within the non-inferiority margin supports the effectiveness of Hayfera. Hafyera should only be used after a patient has been adequately treated with a one-month injectable suspension (e.g. Sustenna) for at least four months, or a one-time three-month injectable suspension (e.g. Trinza). The most common side effects of Hafyera were upper respiratory tract infection, injection site reaction, weight gain, headache, and movement abnormalities (parkinsonism), such as tremors or muscle stiffness. Hayfera includes a boxed warning that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Hafyera is not approved for use in patients with dementia-related psychosis. The labeling contains additional warnings and precautions including possible cerebrovascular (affecting blood vessels or blood supply to the brain) adverse reactions and neuroleptic malignant syndrome (a life-threatening neurological emergency). | 
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