Here Comes Another New Antipsychotic
This one is called lurasidone and it’s developed by Japan’s Dainippon Sumitomo Pharma. The company is so pleased by its phase 3 trials results that it’s going to submit it to the FDA early next year for approval as a treatment for schizophrenia. If approved, the drug would be the third new antipsychotic approved by the FDA in about one year’s time. Vanda’s Fanapt was approved earlier this year although it’s not yet on the market and Schering-Plough’s Saphris, which was approved earlier this month for use in schizophrenia and bipolar disorder.
It’ll be interesting to see how all these new drugs work out in a field crowded with second generation antipsychotics, especially with some of those drugs being off-patent (Risperdal) or about to come off-patent (Zyprexa and Seroquel). These new drugs would have to be pretty spectacular performers–or their makers would need to come up with an appropriate smoke-and-mirrors marketing campaign–to capture many sales because they’ll be competing with mostly generic drugs.
A former FDA reviewer has called Saphris flat-out unsafe and there’s been some skepticism expressed about just how great Fanapt is as well.
The companies with the new drugs have so far mostly claimed that they work as well as nasty drugs like Zyprexa while having fewer side effects. To my ears, that sounds like what Lilly and its shills in academia were saying about Zyprexa vis a vis Haldol in the 1990s. We know how that turned out.
Here’s what a researcher who ran trials of lurasidone said about the drug:
“‘If you look at the weight gain, the lipid changes, it’s among the most benign of any antipsychotic drugs, clearly better than olanzapine, clozapine and Seroquel,’ [Herbert] Meltzer [of Vanderbilt University] said.”
Benign and antipsychotic are two terms that I don’t think anyone can use together with a straight face.
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