J&J’s Risperdal Consta Found No Better Than Cheaper Drugs

Johnson & Johnson’s antipsychotic therapy 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.

Thirty-nine percent of patients on Risperdal Consta, a twice-monthly injection, were hospitalized 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 showed. People on J&J’s treatment also had more side effects, among them headaches and muscle tremors, scientists said.

Risperdal Consta generated $1.5 billion in sales last year for New Brunswick, New Jersey-based J&J. Yesterday’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.”

$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 study is unlikely to hurt J&J, said Glenn Novarro, a New York-based analyst at RBC Capital Markets, in an interview. The company already is 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, he said.

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. 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.

J&J rose 24 cents to $61.05 at 4:01 p.m. in New York Stock Exchange composite trading. Alkermes tumbled $1.54, or 11 percent, to $12.56 in Nasdaq Stock Market composite trading after saying its diabetes drug, Bydureon, failed to show better results than Novo Nordisk A/S’ Victoza in a separate study.

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.

369 Patients

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.

The research wasn’t meant to test whether Risperdal Consta was “non-inferior” to other treatments, which would have required “different analytical assumptions and methods,” said Kara Russell, a J&J spokeswoman, in an e-mailed statement today.

Researchers originally intended to follow 450 patients, Russell said. The study’s lower enrollment “significantly impacted the ability to show a clinically meaningful difference between the treatment groups,” she said.

Jennifer Snyder, an Alkermes spokeswoman, referred questions to J&J’s Russell.

‘Convincing’ Results

The research was “not the largest study of Consta but certainly qualifies as a very large study,” said Rosenheck, the lead investigator. “While no one study is definitive, this is convincing.”

Patients not taking Risperdal Consta were on a variety of alternative medications, among them Zyprexa, made by Indianapolis-based Eli Lilly & Co., 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.