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LATUDA (lurasidone) Melissa Atkinson, Monica Castro, Claudia Chandler, Brocha Choen, Justin Do, Erika Ober

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Case study on Latuda for Graduate Psychology Program

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Page 1: Latuda Presentation

LATUDA (lurasidone)Melissa Atkinson, Monica Castro, Claudia Chandler,

Brocha Choen, Justin Do, Erika Ober

Page 2: Latuda Presentation

DRUG HISTORYMelissa Atkinson

Page 3: Latuda Presentation

FDA APPROVAL HISTORY Jul 1, 2013: Sunovion Pharmaceuticals Inc. Announces

FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression

Oct 28, 2010: FDA approves Latuda to treat schizophrenia in adults

Mar 10, 2010: Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia

Jan 6, 2010: Dainippon Sumitomo Pharma America Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia

Page 4: Latuda Presentation

APPROVAL HISTORYFDA approved: Yes (First approved October 28th,

2010)Brand name: LatudaGeneric name: lurasidoneCompany: Dainippon Sumitomo Pharma

America, Inc.Treatment for: Schizophrenia, Bipolar Disorder

Page 5: Latuda Presentation

BACKGROUND HISTORY Approved for the treatment of schizophrenia and Depressive

episodes in Bipolar 1 Disorder. → Not yet received regulatory approval in the UK.

It was launched in Canada for the treatment of schizophrenia in September 2012.

Switzerland is the first and only European country so far where lurasidone is approved for schizophrenia

It acts as a stronger block on the 5HT7 receptor, which may give it more of an advantage in treating the negative symptoms, as well as improve cognitive and depressive symptoms associated with schizophrenia.

The average price for a 30-day supply of lurasidone is $ 475.98

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RESEARCHJustin Do

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RESEARCH EXPERIMENT4 6-week controlled studies on adult patients

with schizophrenia Recommended starting dose is 40mg/day; -

(without titration)Maximum recommended does 80mg Brief Psychiatric Rating Scale Derived (BPRSD)Positive And Negative Symptom Scale (PANSS)

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RESULTSStudy 1: placebo controlled study (N=145)Fixed dose of 40mg or 120mgBoth doses were significant superior to the

placebo (40mg -9.4 vs -3.8, p=0.018)Study 2: placebo controlled study (N=180)(-8.9 vs -4.2, respectively; P=0.0118).

Page 9: Latuda Presentation

RESULTS IIStudy 3: placebo controlled study in conjunction

to Olanzapine (Zyprexa) (N=473)96.6 for LATUDA, 40 mg/day, 97.9 for LATUDA,

120 mg/day, 96.3 for olanzapine, 15 mg/day, and 95.8 for placebo

40mg (-25.7 vs -16.0,respectively; adjusted P=0.002)

20mg (-23.6 vs -16.0, respectively; adjusted P=0.022)

Page 10: Latuda Presentation

RESULTS IIIStudy 4: placebo controlled

study (N=489)Only 80mg was significant ( -23.4 vs -17.0, respectively;

adjusted P=0.034)

Page 11: Latuda Presentation

AVERSIVE REACTIONSWeight gain Recommend monitoring for symptoms of

hyperglycemia, polydipsia, polyuria, polyphagia, and weakness

EPS 14.7% compared to control 5.1%

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DRUG USESErika Ober

Page 13: Latuda Presentation

WHAT IS LATUDA?Latuda is an atypical antipsychotic.

Similar to other aytpical antipsychotics, Latuda is an antagonist for the dopamine D2 and serotonin 5-HT2A receptors.

Latuda is also an antagonist for the Serotonin 5-HT7 receptor which can have an impact on depression and cognition.

Page 14: Latuda Presentation

FDA APPROVED USESSchizophrenia (2010)The efficacy of Latuda in schizophrenia was

established in five 6-week controlled studies of

adult patients with schizophrenia The effectiveness of Latuda for longer-term

use, has not been established in controlled studies.

Major Depressive episodes associated with Bipolar I Disorder Latuda has been approved for both

monotherapy and adjunctive therapy with either lithium or valproate

The efficacy of Latuda in the treatment of mania associated with bipolar disorder has not been established.

Page 15: Latuda Presentation

DOSAGE AND ADMINISTRATION

Schizophrenia

The recommended starting dose of Latuda is 40 mg once daily. The maximum recommended dose is 160 mg per day.

Depressive Episodes Associated with Bipolar I Disorder

The recommended dose of Latuda ranges from 20 mg to 120mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate.

Page 16: Latuda Presentation

COMMON SIDE EFFECTSClaudia Chandler

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COMMON SIDE EFFECTS

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COMPARIATIVE SIDE EFFECTS

At higher than the recommended dose (120 mg to 160 mg), anxiety, insomnia, agitation, and fatigue predominate.

Dystonia and extrapyramidal side effects are dose-dependent, and are comparable to risperidone, olanzapine, and ziprasidone. There are no significant increases vs placebo in triglycerides, cholesterol, or fasting glucose

(Newcomer J et al, poster presentation at: International Congress on Schizophrenia Research, 2011, Colorado Spring, CO

Page 19: Latuda Presentation

COMPARISONS WITH OTHER ANTIPSYCHOTICS

Lurasidone advantages:

Once-daily dosing Initial dose is therapeutic Minimal weight gain Minimal increase in lipids,

cholesterol, and fasting glucose

Minimal QTc prolongation

Lurasidone disadvantages:

Sedation Akathisia and other EPS No track record of safe use,

therefore possibility of rare post-marketing side effects

No IM or sublingual formulation Expensive Must be taken with food Potential for 3A4 drug

interactions

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SERIOUS SIDE EFFECTSIncreased risk of death in elderly people who are

confused, have memory loss and have lost touch with reality (dementia-related psychosis)

Increased risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions)

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CALL YOUR DOCTOR IF…Thoughts of

SuicideDepressionAnxietyAgitatedInsomnia

Irritability/Aggression

ImpulsivityMania/Mood

Changes

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CONTRAINDICATIONSMonica Castro

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CONTRAINDICATIONS• Latuda should not be taken along with a strong

CYP3A4 inhibitor or inducer• If Latuda is being taken with a moderate CYP3A4

inhibitor the dosage should be half the amount

Page 24: Latuda Presentation

CONTRAINDICATIONS

• If Latuda is being used with a moderate CYP3A4 inducer.

• The dosage may need to be increased after chronic treatment (7days).

• Grapefruit and grapefruit juice should also be avoided

Page 25: Latuda Presentation

CASE EXAMPLEBrocha Cohen

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CASE STUDYBipolar II Disorder

“After about two weeks of taking Latuda it began

to help my depression.”

Page 27: Latuda Presentation

REFERENCES Lurasidone. (n.d.). In Wikipedia. Retrieved July 22,

2014, from http://en.wikipedia.org/wiki/LurasidoneNolan, F. S., & Roman, M. W. (2012). Lurasidone

(Latuda): An Atypical Antipsychotic. Issues in Mental Health Nursing, 33, 342-343.

N.A (2014). Latuda Approval History, retrieved from http://www.drugs.com/history/latuda.html

Risbood, V., Lee, J.R., Roche-Desllets, J., & Fuller, M.A. (2012). Lurasidone: an atypical antipsychotic. The Annals of Pharmacotherapy, 46, 1033-46. doi: 10.1345/aph.1M721.)