J&J's Risperdal Consta No More Effective Than Cheaper Treatments in Study

Johnson & Johnson (JNJ)’s antipsychotic medicine Risperdal Consta, its third-best-selling drug, fared no better than less expensive treatments at keeping schizophrenia patients out of the hospital, U.S. researchers said.

Patients on Risperdal Consta, a twice-monthly injection, ended up in the hospital 39 percent of the time during the three-year analysis, about the same as those who took other drugs as a daily pill, a study released yesterday in the New England Journal of Medicine said. People on the J&J treatment also reported more headaches and muscle tremors among their side effects, scientists found.

Risperdal Consta generated $1.5 billion in sales last year for New Brunswick, New Jersey-based J&J. Today’s findings undercut what has been the injection’s main selling point: that patients are more likely to stay on the medicine because it’s taken less often, said Robert Rosenheck, the study’s lead author. Researchers saw no better adherence after the initial two-week dose, he said.

“This study gives no reason why the use of this treatment should be increased” over other drugs, said Rosenheck, a researcher with the U.S. Department of Veterans Affairs, which funded the study. “It may be effective for individual patients, but as a matter of policy, this is an expensive treatment and there’s no reason to aggressively promote it.”

Photographer: JB Reed/Bloomberg

Tablets of the generic drug Risperidone, seen here, were just as effective at keeping schizophrenia patients out of the hospital as injections of Johnson & Johnson’s more-expensive Risperdal Consta, U.S. researchers said. Close

Tablets of the generic drug Risperidone, seen here, were just as effective at keeping... Read More

Photographer: JB Reed/Bloomberg

Tablets of the generic drug Risperidone, seen here, were just as effective at keeping schizophrenia patients out of the hospital as injections of Johnson & Johnson’s more-expensive Risperdal Consta, U.S. researchers said.

$7,000 Price

A year of Risperdal Consta costs about $7,000 a patient, making it the most expensive of all antipsychotic drugs, said Rosenheck, lead investigator at the VA’s New England Mental Illness, Research Education and Clinical Center.

J&J is contending with product recalls and manufacturing shutdowns that cut sales by $900 million in 2010. The company retracted 40 consumer products last year, led by over-the- counter children’s medicines and Tylenol pain pills, along with artificial hips and contact lenses. U.K. regulators yesterday said the company had also pulled batches of four brands of sutures after faulty packaging threatened their sterile seals.

The journal study is unlikely to hurt J&J sales, said Glenn Novarro, a New York-based analyst at RBC Capital Markets, in an interview. The company has already shifting sales to a newer antipsychotic injection, the once-a-month Invega Sustenna, he said.

Risperdal Consta “is yesterday’s drug,” Novarro said. “It’ll have zero impact on the stock,” he said of the study.

While economic arguments may persuade those who manage health-care systems, doctors are still likely to opt for what seems like a more convenient drug, he said. “It would surprise me if we see any drop-off” in Risperdal Consta sales.

Invega Sustenna

Invega Sustenna, introduced in 2009, generated $183 million in sales last year and may reach $330 million this year, said Lawrence Biegelsen, a Wells Fargo Securities analyst in New York, in a note to clients March 1.

Risperdal Consta is manufactured for J&J by Waltham, Massachusetts-based Alkermes Inc. (ALKS) The drug generated about $146 million, about 82 percent of the company’s total revenue, in the fiscal year that ended in March 2010, according to data compiled by Bloomberg. An Alkermes spokeswoman, Eva Stroynowski, didn’t respond yesterday to messages left after regular business hours.

J&J rose 11 cents to $60.81 at the 4 p.m. close yesterday of New York Stock Exchange composite trading. The shares declined 4.1 percent in the 12 months before today. Alkermes gained 16 cents to $14.10 on the Nasdaq Stock Market.

The study followed 369 patients with a history of hospitalization for the disease. J&J’s Ortho-McNeil Janssen unit, which sells Risperdal Consta, provided an unrestricted funding grant along with free medication.

Non-Inferior Testing

The research was designed to test whether switching to the injection was superior to continuing oral medications, said Kara Russell, a J&J spokeswoman, in an e-mailed statement. “It was not designed to show whether these treatments were non-inferior to each other, which requires different analytic assumptions and methods,” she said.

“We believe changes in the conduct and analysis of this study from the original study protocol significantly compromised meaningful interpretation of the results, especially those related to superiority or equivalence,” Russell said. In a telephone interview, she declined to specify those changes.

Schizophrenia is a mental disorder affecting about 1 in 100 Americans that makes it hard to distinguish reality, think logically and behave normally in social settings, according to the National Institutes of Health. Drug treatments help control severe symptoms, such as hearing voices or violent outbursts. They also can produce side effects such as weight gain, diabetes, and movement disorders.

Patients not taking Risperdal Consta were on a variety of alternative medications, among them Zyprexa, made by Indianapolis-based Eli Lilly & Co. (LLY), and J&J’s Risperdal, an older drug taken as daily pill. The seeming benefit of taking the Consta version only twice a month proved a disadvantage when it came to avoiding side effects, Rosenheck said.

“Patients on oral medication, when they start getting side effects they can cut back on the dose, whereas when you inject somebody with a chemical in their body, they have no control over it,” he said.

To contact the reporter on this story: Alex Nussbaum in New York anussbaum1@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at Rgale5@bloomberg.net

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