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Proven antidepressant efficacy

Powerful and consistent efficacy proven across 3 bipolar depression studies1-3

Results of Three Bipolar Depression Efficacy Studies
Clinical Effect Size of Three Bipolar Depression Studies

Results of Three Bipolar Depression Efficacy Studies
Clinical Effect Size of Three Bipolar Depression Studies

 

*Mean change from baseline to Week 6 in MADRS total score: lithium/valproate + LATUDA 20–120 mg/day: -17.1, lithium/valproate + placebo: -13.51
Mean change from baseline to Week 6 in MADRS total score: LATUDA 20-60 mg/day: -15.4, LATUDA 80-120 mg/day: - 15.4, placebo: -10.7.2
Mean change from baseline to Week 6 in CDRS-R total score: LATUDA 20-80 mg/day: -21.0, placebo: -15.3.3
MADRS=Montgomery- Åsberg Depression Rating Scale.
CDRS-R=Children’s Depression Rating Scale, Revised.

Proven efficacy in adult patients

Your patients can benefit from the power of proven antidepressant efficacy1,2

Adult adjunctive therapy results

Significant symptom improvement starting at Week 3 and maintained through Week 6 (MADRS score) 1*

 

  • LATUDA + lithium/valproate was also proven superior to placebo in the key secondary measure of Clinical Global Impressions scale for use in bipolar illness (CGI-BP)1,4

*MADRS=Montgomery-Åsberg Depression Rating Scale.
Mixed model for repeated measures (MMRM) analysis.
Mean baseline MADRS scores: placebo: 30.8, LATUDA 20–120 mg/day: 30.6.
Mean dose for LATUDA was 66.3 mg/day.5

Adult adjunctive therapy study design1,4,5*

The adult adjunctive therapy study was a 6-week, randomized, double-blind, placebo-controlled trial (N=340) designed to evaluate the efficacy and safety for once-daily LATUDA (20–120 mg/day) as an adjunctive therapy with lithium or valproate in adult patients (mean age of 41.7). Patients enrolled met DSM-IV-TR criteria for major depressive episodes associated with bipolar I disorder, with or without rapid cycling, and without psychotic features. Patients who remained symptomatic after treatment with lithium or valproate were randomized to flexibly dosed LATUDA 20–120 mg/day or placebo. Patients enrolled had blood draws (at screening, at baseline, and throughout the study) to ensure therapeutic levels of lithium or valproate were being maintained. Primary endpoint: mean change from baseline in MADRS score at Week 6. Key secondary endpoint: mean change from baseline in CGI-BP score at Week 6.

Dosing started at 20 mg/day on Days 1–3, increased to 40 mg/day on Days 4–6, increased to 60 mg/day on Day 7, then flexibly dosed from 20–120 mg/day. The mean dose for LATUDA was 66.3 mg/day.

At the end of 6 weeks, eligible patients from the bipolar depression clinical studies continued into a 24-week, open-label study. All patients started on LATUDA 60 mg/day and were flexibly dosed based on response to treatment.


Adult monotherapy results

Significant symptom improvement starting at Week 2 and maintained through Week 6 (MADRS score)2,4*

  • The high-dose range (80–120 mg/day) did not provide additional efficacy, on average, compared to the low-dose range (20–60 mg/day)2,4
  • LATUDA monotherapy also was proven superior to placebo in the key secondary measure of Clinical Global Impressions scale for use in bipolar illness (CGI-BP scores)2,4

*Mixed model for repeated measures (MMRM) analysis.
MADRS=Montgomery-Åsberg Depression Rating Scale.
Mean baseline MADRS scores: placebo: 30.5, LATUDA 20–60 mg/day: 30.3, and LATUDA 80–120 mg/day: 30.6.
Mean dose for LATUDA 20–60 mg/day was 31.8 mg/day.5
Mean dose for LATUDA 80–120 mg/day was 82.0 mg/day.5

Adult monotherapy study design2,4,5*

The adult monotherapy study was a 6-week, randomized, double-blind, placebo-controlled trial (N=485) designed to evaluate the efficacy and safety of 2 dose ranges of LATUDA (20–60 mg/day, 80–120 mg/day) in adult patients (mean age of 41.5). Patients enrolled met DSM-IV-TR criteria for major depressive episodes associated with bipolar I disorder, with or without rapid cycling, and without psychotic features. Primary endpoint: mean change from baseline in MADRS score at Week 6. Key secondary endpoint: mean change from baseline in CGI-BP score at Week 6.

In the LATUDA 20–60 mg/day group, dosing started at 20 mg/day for Days 1–7, then flexibly dosed 20–60 mg/day.

In the LATUDA 80–120 mg/day group, dosing started at 20 mg/day for Days 1–2, increased to 40 mg/day for Days 3–4, increased to 60 mg/day for Days 5–6, increased to 80 mg/day on Day 7, then flexibly dosed to 80-120 mg/day. The mean dose for the LATUDA 20–60 mg/day group was 31.8 mg/day. The mean dose for the LATUDA 80–120 mg/day group was 82.0 mg/day.

At the end of the 6 weeks, eligible patients from the bipolar depression clinical studies continued into a 24-week, open-label study. All patients started on LATUDA 60 mg/day and were flexibly dosed based on response to treatment.

Proven efficacy in pediatric patients

The ONLY FDA-approved monotherapy to treat pediatric patients (10 to 17 years) with bipolar depression

Pediatric monotherapy results

Significant symptom improvement starting at Week 2 and maintained through Week 6 (CDRS-R score)3,4*

  • LATUDA monotherapy was also proven superior to placebo in the key secondary measure of Clinical Global Impression-Bipolar Severity (CGI-BP-S) depression score4
  • At the end of the pediatric study, most of the patients (67%) received 20 mg/day or 40 mg/day3,4

*Mixed model for repeated measures (MMRM) analysis.
CDRS-R=Children’s Depression Rating Scale, Revised.
Mean baseline CDRS-R scores: placebo: 58.6, LATUDA 20-80 mg/day: 59.2.
Mean dose for LATUDA 20-80 mg/day was 32.5 mg/day.6

Pediatric monotherapy study design3,4,5

The pediatric study was a 6-week, randomized, parallel, double-blind, placebo-controlled trial (N=343) designed to evaluate the efficacy and safety of flexibly dosed LATUDA (20–80 mg/day) as a monotherapy in pediatric patients (mean age: 14.2). Patients enrolled met DSM-5 criteria for a major depressive episode associated with bipolar I disorder, with or without rapid cycling, and without psychotic features. Primary endpoint: mean change from baseline in CDRS-R score at Week 6.

In the LATUDA 20–80 mg/day group, dosing started at 20 mg/day on Days 1–7, then flexibly dosed 20–80 mg/day. The mean dose for LATUDA was 32.5 mg/day.


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References:

  1. Loebel A, Cucchiaro J, Silva S, et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2013;171(2):169-177.
  2. Loebel A, Cucchiaro J, Silva S, et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2013;171(2):160-168.
  3. DelBello MP, Goldman R, Phillips D, Deng L, Cucciaro J, Loebel A. Efficacy and safety of lurasidone in children and adolescents with bipolar I depression: a double-blind, placebo-controlled study. Am Acad Child Adolesc Psychiatry. 2017;56(12):1015-1025.
  4. Latuda® (lurasidone HCl) prescribing information. Sunovion Pharmaceuticals Inc. March 2018.
  5. Cucchiaro J. A Randomized, 6-week, double-blind, placebo-controlled, fixed flexible-dose, parallel-group study of lurasidone for the treatment of bipolar I depression. Clinical Study Report D1050236. February 2012.
  6. Data on file. Sunovion Pharmaceuticals Inc.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

 

CONTRAINDICATIONS: LATUDA is contraindicated in the following:

Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials, elderly subjects with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. LATUDA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported with administration of antipsychotic drugs. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of antipsychotic drugs, including LATUDA, intensive symptomatic treatment and monitoring.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes Atypical antipsychotic drugs have caused metabolic changes including:

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Monitor complete blood count in patients with a pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) or history of drug-induced leukopenia/neutropenia. Discontinue LATUDA at the first sign of a decline in WBC in the absence of other causative factors.

Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest at the beginning of treatment and when increasing the dose. Monitor patients vulnerable to hypotension and those with cardiovascular and cerebrovascular disease.

Falls: Antipsychotics may cause somnolence, postural hypotension, or motor and sensory instability, which may lead to falls, causing fractures or other injuries. For patients with disease, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy.

Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

Potential for Cognitive and Motor Impairment: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with LATUDA does not affect them adversely.

Body Temperature Regulation: Use LATUDA with caution in patients who may experience conditions that increase body temperature (e.g., exercising strenuously, exposure to extreme heat, concomitant medication with anticholinergic activity, or being subject to dehydration).

Dysphagia: Antipsychotics, including LATUDA, have been associated with esophageal dysmotility and aspiration, and should be used with caution in patients at risk for aspiration pneumonia.

Most Commonly Observed Adverse Reactions: Commonly observed adverse reactions (≥5% incidence and at least twice the rate of placebo) for LATUDA:

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 877-737-7226 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Indications

LATUDA is indicated for:

Before prescribing LATUDA, please read the full Prescribing Information, including Boxed Warning.