Johnson & Johnson has had little trouble keeping sales from its Invega portfolio of long-acting antipsychotic injectables in the billions. Now, it's angling for approval of an even more durable formulation that could further hone the drug's convenience edge over competitors.
Johnson & Johnson’s Janssen unit submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for its long-acting injectable schizophrenia treatment, paliperidone palmitate 6-month (PP6M).
If approved, PP6M would be the first and only long-acting injectable schizophrenia medication administered just twice yearly, Janssen said.
By cutting the number of medication intervals that schizophrenia patients and their healthcare teams juggle, Janssen aims to give patients more time to focus on other aspects of their treatment plans, such as psychosocial intervention, Bill Martin, global therapeutic area head of neuroscience at Janssen R&D, said in a release.
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The drugmaker based the submission on results from its late-stage Route 6 trial, which enrolled 702 adults living with schizophrenia from 20 countries. In that trial, the 6-month formulation’s performance matched paliperidone palmitate 3-month (PP3M) at staving off relapse, and the drug’s safety profile measured up to that of both the 3-month and 1-month formulas, Janssen said.
If the new formulation passes the FDA’s bar, patients will receive PP6M after being stabilized on shorter-acting versions of the drug, with the goal to ultimately administer fewer injections.
Janssen’s 1-month and 3-month formulations of paliperidone palmitate, sold as Invega Sustenna and Invega Trinza, respectively—along with a third long-acting injectable, Risperdal Consta—are currently approved to treat adults with schizophrenia in the U.S. and are all administered in the clinic.
The company's Invega portfolio pulled in $3.3 billion in 2019 sales, up 13.7% from the previous year’s $2.9 billion, according to the company’s annual report (PDF).
Meanwhile, Johnson & Johnson's long-acting injectables business has endured its share of challenges over the past few years. The company in 2013 agreed to settle with the U.S. Department of Justice for $2.2 billion after eight years of allegations that it marketed its antipsychotic drug Risperdal off label—including for use in children and teenagers before the drug had won approval in those age groups. The settlement also closed probes into other drugs, including Invega.
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As for Invega itself, the 1-month Sustenna formulation in early 2018 won clearance to include new label language stating the drug could delay the arrest or incarceration of patients taking it.
The move didn’t go over well with everyone; at the time, John Snook, executive director of the Treatment Advocacy Center, told The Marshall Project—a nonprofit organization focused on criminal justice—that marketing a drug on the prospect of reduced jail time was a “depressing commentary” on mental health treatment.
The Big Pharma isn’t alone in offering long-term treatment options for schizophrenia, either. Otsuka sells the long-acting injectable antipsychotic Abilify Maintena, used to treat schizophrenia and bipolar disorder and as an add-on for major depressive disorder.
The company also sells Abilify Mycite, a digital pill that allows patients to share dosing information with their healthcare providers and caregivers.