3. 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
4. APPROVAL HISTORY FDA approved: Yes (First approved October 28th, 2010) Brand name: Latuda Generic name: lurasidone Company: Dainippon Sumitomo Pharma America, Inc. Treatment for: Schizophrenia, Bipolar Disorder
5. 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
6. RESEARCH Justin Do
7. RESEARCH EXPERIMENT 4 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)
8. RESULTS Study 1: placebo controlled study (N=145) Fixed dose of 40mg or 120mg Both 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).
9. RESULTS II Study 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)
10. RESULTS III Study 4: placebo controlled study (N=489) Only 80mg was significant ( -23.4 vs -17.0, respectively; adjusted P=0.034)
11. AVERSIVE REACTIONS Weight gain Recommend monitoring for symptoms of hyperglycemia, polydipsia, polyuria, polyphagia, and weakness EPS 14.7% compared to control 5.1%
12. DRUG USES Erika Ober
13. 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.
14. FDA APPROVED USES Schizophrenia (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.
15. 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.
16. COMMON SIDE EFFECTS Claudia Chandler
17. COMMON SIDE EFFECTS
18. 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
19. 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
20. SERIOUS SIDE EFFECTS Increased 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)
21. CALL YOUR DOCTOR IF Thoughts of Suicide Depression Anxiety Agitated Insomnia Irritability/Aggressio n Impulsivity Mania/Mood Changes
22. CONTRAINDICATIONS Monica Castro
23. 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
24. CONTRAINDICATION S 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
25. CASE EXAMPLE Brocha Cohen
26. CASE STUDY Bipolar II Disorder After about two weeks of taking Latuda it began to help my depression.