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Home » Drug Information » FDA Approved Drugs » 2010
Medical Areas: Psychiatry/Psychology

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Latuda (lurasidone)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Sunovion
Approval Status: Approved October 2010
Treatment Area: schizophrenia

General Information

Latuda (lurasidone) is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. The mechanism of action of lurasidone is unknown, however has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D ) and serotonin Type 2 (5HT2A) receptor antagonism.

Latuda is specifically indicated for the treatment of patients with schizophrenia.

Latuda is supplied as a tablet for oral administration. The recommended starting dose is 40 mg once daily and the maximum recommended dose is 80 mg/day. Latuda should be taken with food (at least 350 calories). Dose adjustments are recommended for the following: patients with moderate and severe renal impairment, patients with moderate and severe hepatic impairment, patients taking concomitant potential CYP3A4 inhibitors and patients taking concomitant potential CYP3A4 inducers.

Clinical Results

FDA Approval
The FDA approval of Latudat was based on four short-term (6-week), placebo-controlled studies in adult patients (mean age of 38.8 years) who met DSM-IV crit eria for schizophrenia. Efficacy was based on the Positive and Negative Syndrome Scale (PANSS), the Brief Psychiatric Rating Scale derived (BPRSd), derived from the PANSS and the Clinical Global Impression severity scale (CGI-S). The endpoint was a comparision of the change from baseline in the total score to the end of week 6 between Latuda, placebo and control groups. The results are as follows:
Study One
This trial enrolled 145 subjects and compared two fixed doses of Latuda (40 or 120 mg/day) to placebo. Both doses of Latuda were superior to placebo on the BPRSd total score, and the CGI-S.
Study Two
This study enrolled 180 subjects and compared a fixed dose of Latuda (80 mg/day) to placebo. Latuda was superior to placebo on the BPRSd total score, and the CGI-S.
Study Three
This placebo and active-controlled trial enrolled 473 subjects and compared two fixed doses of Latuda (40 or 120 mg/day) and an active control (olanzapine) to placebo. Both Latuda doses and the active control were superior to placebo on the PANSS total score, and the CGI-S.
Study Four
This trial enrolled 489 subjects and compared three fixed doses of Latuda (40, 80 or 120 mg/day) to placebo. Only the 80 mg/day dose of Latuda was superior to placebo on the PANSS total score, and the CGI-S.

The efficacy of Latuda at doses of 40, 80 and 120 mg/day was established in two studies for each dose. However, the 120 mg dose did not appear to add additional benefit over the 40 mg dose.

Side Effects

Adverse events associated with the use of Latuda may include, but are not limited to, the following:

  • Somnolence
  • Akathisia
  • Nausea
  • Parkinsonism
  • Agitation

Mechanism of Action

Latuda (lurasidone) is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. The mechanism of action of lurasidone is unknown, however has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D ) and serotonin Type 2 (5HT2A) receptor antagonism.

Literature References

Ishibashi T, Horisawa T, Tokuda K, Ishiyama T, Ogasa M, Tagashira R, Matsumoto K, Nishikawa H, Ueda Y, Toma S, Oki H, Tanno N, Saji I, Ito A, Ohno Y, Nakamura M Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity. The Journal of pharmacology and experimental therapeutics 2010 Jul;334(1):171-81

Nakamura M, Ogasa M, Guarino J, Phillips D, Severs J, Cucchiaro J, Loebel A Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. The Journal of clinical psychiatry 2009 Jun;70(6):829-36

Additional Information

For additional information regarding Latuda or schizophrenia, please visit the Latuda web page.