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2021-09-02| Trials & Approvals

Janssen’s Long-acting Schizophrenia Drug Notches FDA Approval

by Joy Lin
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On September 1st, J&J subsidiary Janssen Pharmaceuticals announced the FDA approval of Invega Hayfera ( six-month paliperidone palmitate), its long-acting schizophrenia drug. Invega Hayfera is the first and only long-acting drug to manage schizophrenia symptoms for six months on a single dose.

With this, the drug joins other FDA-approved treatments developed by Janssen. They include Invega Sustenna and Invega Trinza, its once-a-month and three-month counterparts, respectively. It also joins Risperdal Consta (risperidone), a biweekly treatment for schizophrenia.

 

Promising Results of Route 6 Trial

A Phase 3 non-inferiority Route 6 study, which enrolled 702 adults around the world, showed that Invega Hayfera matched the performance of Invega Trinza, its three-month counterpart, in managing symptoms of schizophrenia.

Results showed that about 92.5% of patients treated with Invega Hayfera and 95% treated with Invega Trinza were relapse-free at 12 months.

This means the drugs were similarly effective in preventing deterioration from the disease and patients did not develop harmful or self-harming behaviors that resulted in psychiatric hospitalization.

“Before I found the right treatment plan for me, my symptoms often got in the way of things that I loved to do,” said Patrick, an adult living with schizophrenia and a participant in the clinical trial.

Ever since his doctor introduced him to the Route 6 trial,  Patrick says his symptoms are controlled, giving him “the clarity to focus on the present” and “the stability to plan for my future.”

Related Article: Addressing The Global Need for Biosimilars: Current Trends, Expectations and Real World Experiences

 

Safety Data

The safety profile of Invega Hayfera was consistent with previous studies of Invega Sustenna and Invega Trinza. While the drug did not raise any new safety signals, a few recipients still experienced adverse events. About 12% developed upper respiratory tract infection, while 11% had adverse reactions at the injection site. Weight gain, headache, and parkinsonism were also some of the more commonly reported side effects.

The drug is not recommended for elderly people with dementia-related psychosis. There is an additional catch for patients hoping to get started on Invega Hayfera — they must first complete a treatment regime consisting of either four months on the monthly formulation (Invega Sustenna) or one cycle of the three-month formulation (Invega Trinza).

 

Rationale for a Long-acting Drug

Schizophrenia is a complex brain disorder that negatively impacts one’s thinking, perception, emotions, and behavior. While incurable, many treatments alleviate symptoms, allowing patients to live relatively normal lives. Most treatments involve a mix of psychotherapy and taking daily oral pills.

Recently, Waltham, MA-based Alkermes bagged the FDA approval for its daily oral antipsychotic, Lybalvi, to treat adults with schizophrenia and bipolar I disorder.

However, patient non-compliance with daily drugs is high. Patients might forget to take the daily drugs or believe they’ve already improved past the point of continuing the medications.  They may also be put off by side effects. Long-acting drugs provide a way out as patients need to make just one trip to the clinic to get periodic injections, which in the case of Invega Hayfera is once every six months.

A 2020 study on over 75,000 schizophrenic patients found that long-acting injections cut the hospital readmission risks by 20-30% compared with taking oral medication.

 

Long-lasting Treatments for Schizophrenia 

Janssen’s drugs are not the only long-acting antipsychotics on the market. Otsuka Pharmaceuticals and Lundbeck co-developed Abilify Maintena (aripiprazole), which can be taken as a monthly injection for patients with schizophrenia or bipolar disorder.

Eli Lilly also has Zyprexa Relprevv (olanzapine), which could be administered every two to four weeks. Other long-lasting injectables include Haldol (haloperidol decanoate) and Prolixin (fluphenazine enanthate and decanoate).

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