Sunovion Pharmaceuticals' new antipsychotic drug has hit drugstores, aiming to capture a share of the already crowded market. It's a branded drug in a class that now includes one leading generic--risperidone, the knock-off form of Johnson & Johnson's Risperdal--and soon will have more. The difference, Sunovion says, is that Latuda doesn't cause the weight gain so typical of the atypicals.
Latuda won FDA approval last fall on the strength of four studies in schizophrenia patients. Weight gain didn't crop up during those studies, but they were only six weeks long. Now, however, Sunovion has some long-term safety data, from a head-to-head, 12-month study that compared Latuda to risperidone. Latuda patients in that trial actually lost weight--0.9 kg, on average--while the risperidone patients gained an average of 2.6 kg. Blood sugar fell in Latuda patients, and triglycerides fell, too, while risperidone patients experienced increased blood sugar and a smaller drop in triglycerides, the company says.
However, there are some caveats. Only 147 Latuda patients finished the trial, or 34 percent, and more Latuda patients than risperidone patients dropped out because of side effects--17 percent versus 11 percent. Latuda may seem to keep weight gain at bay, but patients complained of nausea, vomiting, and restless muscle movements.
There are two complicating factors, however. The company has priced Latuda at $14 per pill, or about $5,000 per year. In addition, Eli Lilly's Zyprexa goes off patent later this year, and AstraZeneca's Seroquel loses exclusivity in early 2012. Both have been linked to weight gain, but will patients and payers be willing to pay the price for a new brand, on the promise that it won't?
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- see the trial news
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