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FDA Approves Four-Times-Per-Year Schizophrenia Drug

Brain synapses illustration

(Allan Ajifo, Wikimedia Commons)

19 May 2015. Food and Drug Administration approved for sale in the U.S. a drug for controlling schizophrenia symptoms that individuals need to take only four times per year. Janssen Pharmaceuticals, a division of Johnson & Johnson, markets the three-month version of the drug paliperidone palmitate under the brand name Invega Trinza.

Schizophrenia is a common and chronic, yet severe and disabling disorder that affects about 1 percent of the U.S. population, but takes a wider toll on families and society. Symptoms of schizophrenia include hallucinations such as hearing voices, delusions, or agitated movements, as well as disrupted emotions and behavior affecting interactions causing lack of focus or loss of memory. Schizophrenia affects men and women, mainly adults, about equally and occurs at similar rates among ethnic groups around the world.

Medications are helping people with schizophrenia manage their symptoms since the 1950s, with a new class of drugs known as second-generation or atypical antipsychotics available since the 1990s. Among this newer type of drug is paliperidone, a small-molecule compound that affects neurotransmitters such as dopamine and serotonin in the brain. Janssen markets paliperidone as Invega, both as an extended release tablet and injections.

FDA approved Invega Trinza as a treatment for individuals with schizophrenia given by injection every three months who are first successfully treated for at least four months with once-a-month injections of Invega Sustenna. Less-frequent dosages of symptom control medications are considered an advantage in therapy programs that often require individualized attention because of the range of symptoms and personal circumstances of people with the disorder.

FDA approved Invega Trinza based in part on results of a late-stage clinical trial that measured the median time for a relapse of schizophrenia to occur among people receiving the three-month injections or a placebo. More than 500 individuals with schizophrenia took part in the trial at 56 locations in the U.S., Europe, and Latin America.

All participants first received a monthly injection of Invega Sustenna, then a single dose of the three-month paliperidone to stabilize their symptoms. Participants were then randomized to continue receiving paliperidone or a placebo every three months during the test phase. The results, published in March 2015 in the journal JAMA Psychiatry, show 93 percent of of participants taking the three-month dose of paliperidone experienced no serious schizophrenia symptoms, while the placebo participants relapsed in a median time of 274 days.

Because of the positive results, an independent monitoring committee decided to end the clinical trial early. The researchers found the rate of adverse events about the same between the paliperidone and placebo groups, with those in the paliperidone group experiencing more weight gain, headache, common cold, and akathisia — restlessness and fidgeting.

FDA approved Invega Trinza under priority review, a program that expedites review of drugs designed to treat serious conditions and offer significant improvements in safety or effectiveness.

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Disclosure: The author owns stock in Johnson & Johnson, the parent company of Janssen Pharmaceuticals.

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