The FDA has warned Pfizer to keep closer tabs on its clinical trials. At issue: a pediatric trial of its antipsychotic drug Geodon. According to the agency, at least 13 children in the trial received overlarge doses of the drug. Pfizer “failed to ensure proper monitoring” of the trial, and the “widespread overdosing” was neither “detected nor corrected in a timely manner,” the letter states.

Pfizer is working toward FDA approval to market Geodon as a treatment for bipolar disorder in children, and this trial is part of that effort. An advisory committee has given “cautious support” to the new indication, Reuters reports. When submitting trial results to the FDA, Pfizer excluded data from trial sites with “widespread violations,” the company said.

The children who received overdoses did experience side effects such as tremors and restless legs, but they didn’t last, and there was no long-term injury, the company said. Just two of the patients did not continue with the study.

Pfizer also said that it has improved its oversight of clinical trials. The company “has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators,” Pfizer says in a statement.

Source: FiercePharma

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The feds say J&J paid kickbacks to a big nursing-home pharmacy company to get the company to prescribe more of its drugs, including the antipsychotic Risperdal.

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The allegation isn’t a huge surprise: The pharmacy company, Omnicare, paid $98 million last year to settle allegations that it had solicited and received kickbacks from J&J in exchange recommending the company’s antipsychotic drug Risperdal.

J&J told the WSJ today that “airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.”

As we noted when the Omnicare settlement was announced, the story of nursing-home patients getting antipsychotics is long and thorny.

Risperdal, like many other psychotics, raises the risk of death in patients with psychosis that stems from dementia, and isn’t approved to treat this form of psychosis. Nevertheless, the drugs have been widely prescribed to nursing-home patients with dementia, as the WSJ reported back in 2007.

J&J isn’t the only company that’s been accused of wrongdoing in this market. Eli Lilly used a “5 at 5″ slogan to promote the antipsychotic Zyprexa’s side effect of sedation to nursing-home doctors, according to the Department of Justice: 5 milligrams of the drug at 5 p.m. would help patients sleep.

Eli Lilly paid a $1.42 billion settlement and pleaded guilty to a misdemeanor as part of a broad DOJ inquiry into the way the company marketed Zyprexa.

Source: The Wall Street Journal

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More proof that FDA warnings make a difference: Alerts about the risks of antipsychotic drugs appear to have depressed sales by some 19 percent, a new Archives of Internal Medicine study finds. “We concluded that it resulted in a modest reduction,” researcher Dr. Ray Dorsey of the University of Rochester Medical Center says. Why modest? In part because antipsychotic scrips still accounted for 9 percent of prescriptions in the elderly in 2008.

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Studies have shown that atypical antipsychotics–which include such best-selling drugs as Eli Lilly’s Zyprexa and Johnson & Johnson’s Risperdal–carry various safety risks, and the FDA has added strong warnings to the drugs’ labeling. This study looks at a warning that the atypicals boost the risk of death in elderly people with dementia; that “black box” was added to the meds in 2005.

The researchers analyzed data on the use of those drugs from January 2003 to December 2008, finding that 19 percent decline in sales. But the group didn’t have data on how many people might have benefited from the warning, Reuters reports. Nor did the researchers want to characterize the FDA’s warning as a success or failure. “It’s hard to say whether 20 percent is the right number,” Dorsey tells the news service.

A commentary accompanying the study, however, posits that regulatory warnings about the atypical antipsychotics have had little effect on prescription numbers. “There’s a real disconnect between the evidence and the prescribing patterns,” co-author Becky A. Briesacher, associate professor at the University of Massachusetts Medical School in Worcester, tells HealthDay. Some geriatric doctors said that sometimes the benefits outweigh those risks. “The only medications that have been shown to work are antipsychotics, but the problem is they have side effects,” says Dr. Davangere Devanand of the New York State Psychiatric Institute. “It’s a balance.”

Source: FiercePharma

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Kids taking the latest generation of antipsychotic meds gain significant amounts of weight–as much as 19 pounds on average in just 11 weeks for kids taking Zyprexa, according to a study published today in JAMA. Abilify, Risperdal and Seroquel were all linked to weight gain as well. Here’s the WSJ story.

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In fact, every one of the more than 200 children and adolescents who took the medicines in the study added weight, Christoph Correll, a psychiatrist who was one of the authors of the study, told the Health Blog. For some drugs, doses didn’t matter; for others, they did.

The link to weight gain has been clear for a while. But it’s not entirely clear why people gain weight when they start taking these drugs, according to Correll. Answering that question could help explain how weight gain works in people who aren’t mentally ill. “Most likely these medications are using the same pathways associated with obesity,” Correll said.

In the meantime, docs should keep close tabs on the weight of kids who are taking these drugs. “The onset of the weight gain was so pronounced and so significant there’s probably an argument for doing those measurements every few weeks,” a child psychiatrist who wrote an editorial that accompanied the study told the WSJ.

Source: The Wall Street Journal

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AstraZeneca scored another victory in its legal battle against thousands of plaintiffs claiming that the antipsychotic drug Seroquel caused their diabetes.

A Delaware Superior Court judge late yesterday dismissed a case filed by plaintiff Nina Scaife because the judge was unconvinced by one of the plaintiff’s expert witnesses -– a doctor who testified that Seroquel caused Scaife’s Type 2 diabetes. The witness, Valerie Peck, failed to rule out other likely causes of the plaintiff’s diabetes, the judge wrote. She also “improperly relied upon the temporal proximity of the plaintiff’s exposure to Seroquel and the onset of her diabetes in forming her opinion,” the judge, Joseph Slights, wrote.

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The case is the third in the Seroquel litigation to be dismissed, following a Florida judge’s move earlier this year to toss out two similar cases for similar reasons. Those cases had been filed in U.S. District Court for the Middle District of Florida.

Tony Jewell, an AstraZeneca spokesman, told the Health Blog that the latest dismissal “supports our position that as plaintiffs cases are examined…it is clear they are not worth pursuing.”

Mr. Jewell added that after Judge Slights issued his opinion last night, lawyers representing another plaintiff in Delaware approached AstraZeneca offering to dismiss their case. AstraZeneca agreed to this, without settling the case, he said.

The company faces another 9,000 or so lawsuits from patients who allege they developed diabetes after taking Seroquel.

Source: The Wall Street Journal

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Vanda Pharmaceuticals announced Wednesday that the FDA approved Fanapt (iloperidone) to treat schizophrenia in adults.

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The approval for Fanapt was based on two late-stage studies comparing the atypical antipsychotic to placebo and active control in patients with schizophrenia. Vanda noted that use of Fanapt in clinical trials “was not associated with any medically important elevations in glucose, triglycerides or cholesterol.” The company said use of the drug was associated with “mild” weight gain, and overall mean weight increase in patients across all short- and long-term studies was 2.1 kilograms.

In July 2008, the FDA issued a not-approvable letter for Fanapt, due in part to concerns about the drug’s efficacy compared with Johnson & Johnson’s Risperdal (risperidone) in previous studies.

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Bristol-Myers Squibb is making its upcoming patent cliff somewhat less painful.

The company said this morning it has gotten an extension of its U.S. marketing rights to the antipsychotic Abilify, which it sells with Japan’s Otsuka Pharmaceutical. The partnership had been set to expire in November, 2012, leaving Otsuka with full rights to the drug. Under the new agreement, the partnership will expire in April 2015, when Abilify is expected to go generic.

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This all matters because Bristol is already anticipating a huge sales gap when its biggest seller, the anticlotting drug Plavix, is expected to go generic not long before that Abilify agreement would have expired in 2012. Plavix generated $5.6 billion in sales for Bristol last year, while Abilify, the company’s second-biggest seller, brought in $2.2 billion. If Bristol were to lose both drugs at once, it would have been especially painful.

So Bristol is paying up in order to avoid such a fate, to the tune of $400 million for Otsuka. Under the deal, Bristol’s share of Abilify’s sales will gradually drop to 50% from 65%. The company will also collaborate with Otsuka on two of its cancer drugs, Sprycel and Ixempra, that are on the market. Read about the details in the WSJ.

Source: The Wall Street Journal

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Eli Lilly reported at the International Congress on Schizophrenia Research that Phase II study results of its experimental schizophrenia treatment LY2140023 were “inconclusive,” due to a greater-than-expected response in patients taking placebo. The company said it plans to undertake an additional mid-stage study on the compound next year, and it explained that the decision to continue development is based in part on previously announced data for the drug.

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The most recent trial enrolled 669 patients with acute schizophrenia, 393 of whom completed the four-week study. A primary analysis showed that none of the four doses of LY2140023 administered twice daily “separated from placebo.” In addition, Eli Lilly noted that for patients who took the comparator drug Zyprexa (olanzapine) once daily, Zyprexa did not separate from placebo. The drugmaker said the higher-than-expected placebo response was approximately double what has typically been observed in schizophrenia clinical trials.

Regarding side effects, findings showed that LY2140023 had a “low association” with adverse events commonly linked with current antipsychotic treatments, and that patients taking LY2140023 showed no appreciable weight gain. However, Eli Lilly also indicated that convulsions were observed in three patients taking its experimental mGlu2/3 receptor agonist.

Commenting on the news, Steven Paul, president of Lilly Research Laboratories, stated that the company “remains optimistic that the novel mechanism of compounds with the ability to reduce glutamate hyperactivity…will someday represent the next generation of breakthrough treatments for schizophrenia.” However, Leerink Swann analyst Seamus Fernandez described the data as a “serious blow” to Eli Lilly’s pipeline, saying that “any additional studies [with LY2140023] should be viewed as exploring the mGlu2/3 mechanism, but the agent should not move forward into Phase III studies due to safety concerns.”

Source: FirstWord

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Eli Lilly is resisting getting caught up in the wave of drug-industry consolidation.

After Pfizer-Wyeth, Merck/Schering-Plough and Roche-Genentech, Lilly CEO John Lechleiter told the Financial Times his company isn’t interested in a mega-merger, and he ruled out a tie-up with Bristol-Myers Squibb.

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“I think we are seeing deals that are really driven more by weakness than what I would describe as strong strategic combinations,” Lechleiter told the FT. “That will improve short-term problems but fail to answer the long-term question of research productivity.”

As the WSJ explained a few weeks ago, Lilly is looking relatively small in the wake of the mega mergers, and it’s facing the loss of patent protection of the big-selling antipsychotic Zyprexa in 2011. Lilly would more likely be a buyer than a seller. Still, a spokesman told the WSJ that the company isn’t interested in large-scale M&A and believes that “small and medium scale acquisitions, licensing and internal development” are the best way forward for Lilly.

“Call me a stubborn Midwesterner, but I/we continue to believe that these megadeals never made any sense to begin with and don’t make sense now,” Lechleiter wrote in an in-house blog post, as quoted by the FT. “We are flat out not interested in being part of a big combination.”

Update: Lechleiter tells the WSJ he is interested in acquisitions of up to about $15 billion. “I got hungry again about three weeks after ImClone got closed,” he said. Here’s the full WSJ story.

Source: The Wall Street Journal

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Eli Lilly announced on Monday that the FDA granted expanded approval for Symbyax (olanzapine/fluoxetine) in the acute treatment of treatment-resistant depression (TRD). The new indication applies to adults with major depressive disorder who have twice experienced failure to respond to other antidepressants during their current episode, and the company said its combination product is the first drug to receive FDA approval for this use.

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The FDA also approved the use of its antipsychotic Zyprexa (olanzapine), in combination with Prozac (fluoxetine), in adults for the acute treatment of bipolar depression and for the acute treatment of TRD, the drugmaker said.

Additionally, Eli Lilly reported that the company updated the labels for Zyprexa and Symbyax to include extra information on weight gain, hyperglycaemia and hyperlipidaemia in patients taking the drug. The move follows an FDA review of study data which the drugmaker submitted to the agency between August 2007 and July 2008.

Source: FirstWord

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