Latuda (lurasidone HCl), an atypical antipsychotic medication developed by Sunovion Pharmaceuticals Inc. (Fort Lee, NJ)received final FDA approval on Oct. 29 and will become widely available to prescribers and patients in the first quarter of 2011.
According to Herbert Meltzer MD, a consultant to Sunovion and the Bixler/May/Johnson Professor of Psychiatry and Professor of Pharmacology at Vanderbilt University (Nashville, TN) , “Latuda is another serotonin-dopamine antagonist in the tradition of clozapine, risperidone, and olanzapine.” Meltzer says that such atypical antipsychotics have become a principal tool because they, as a group “are far safer” for patients than “first generation” antipsychotics, which were associated with a relatively high incidence of tardive dyskinesia and "extrapyramidal" side effects.
While Meltzer says that all atypicals have a “similar core pharmacology” and “do a good job of treating non-treatment resistant schizophrenia,” Latuda, like each of the other atypicals, “has enough difference in receptor profiles and pharmacodynamic properties to make for some real differences.”
“The differences we’ve learned are clinically important are differences in side effects, frequency of administration, and dosing,” he explains. “What we’re seeing with Latuda is really very promising in terms of the side effect profile and dosage. What you see is that it has minimal side effects in the metabolic area,” which he says is “the number one issue” of prescriber concern with regard to this class of medication.
He observed that, based on Program to Evaluate Antipsychotic Response to Lurasidone (PEARL 2) trial results, weight gain among patients on Latuda was “markedly lower” than that of patients taking olanzapine. “Weight gain results with Latuda are right there with ziprasidone and aripiprazole, so clinicians and patients are going to find that useful.” He added that the medication did not tend to elevate the hormone prolactin, which is associated with sexual dysfunction, osteoporeosis, and lactation problems and that Latuda is “not particularly sedative” for the patient.
Studies show that Latuda showed no significant differences in efficacy between a low (40 mg) and high (120 mg) dosage. And, unlike some other atypicals, Meltzer says that Latuda dosages do not require a lot of titration. “If you have an acutely ill patient, you can start them at 40 [mg] and it’s going to start to work within days, if not hours, based, of course, on how ill the patient is. You don’t have to experiment [with the dose] as you do with, say, quetiapine, where it is difficult to know how a patient is going to respond. Here, most everybody is going to respond to 40 or 80 and [prescribers] will probably see that they can use 40 mg.”
Regarding side effects, Meltzer said that a mild restlessness—akathesia—that was seen at all dosages, but that “it almost never led to discontinuation. I don’t think that will be a real disadvantage.”
Author's Note: Sunovion Pharmaceutials has not conducted head-to-head trials comparing LATUDA directly to other treatment options. Olanzapine was included in the Program to Evaluate Antipsychotic Response to Lurasidone (PEARL) trials only for the purpose of establishing assay sensitivity. Complete prescribing information for Latuda is also available.