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Secondary endpoint: daily functioning and quality of life

Based on patient-reported data at Week 6 vs placebo*

Adult patients with bipolar depression on adjunctive therapy

Patient-reported functional outcomes

Reduction in patient-reported functional impairment at Week 6 (SDS Score) on LATUDA + lithium/valproate versus placebo + lithium/valproate1,3*

*Last observation carried forward (LOCF) analysis.
SDS=Sheehan Disability Scale.
Scale range, 0-30, with higher scores indicating greater impairment.
Mean baseline SDS scores: placebo: 20.1; LATUDA 20-120 mg/day: 19.5. 

SDS is a validated, patient self-rated scale used to assess functional impairment associated with depressive symptoms.3,4

The scale measures functional impairment across 3 domains: work/school, social life, and family life. Scores range from 0 (unimpaired) to 30 (highly impaired).


Patient-reported quality of life 

Improvement in patient-reported quality of life at Week 6 (Q-LES-Q-SF score) on LATUDA + lithium/valproate versus placebo + lithium/valproate1,3*

Q-LES-Q-SF is a validated, patient self-rated scale used to assess satisfaction and enjoyment in various areas of daily living.4,6,7†

The scale measures quality of life across 14 items such as physical health, mood, work, household activities, social relationships, family relationships, leisure-time activities, sexual interest and drive, ability to function in daily life, economic status, living/housing situation, ability to move around without dizziness, vision in terms of work and hobbies, and overall sense of well-being.

*Last observation carried forward (LOCF) analysis.
Q-LES-Q-SF=Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form.
Scale range, 14-70, with higher scores indicating better quality of life.
Mean baseline Q-LES-Q-SF scores: placebo: 35.7; LATUDA 20-120 mg/day: 36.1.

 

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 to 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.

PRIMARY ENDPOINT: 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

Adult patients with bipolar depression on monotherapy

Patient-reported functional outcomes

Reduction in patient-reported functional impairment at Week 6 (SDS score) versus placebo4,8*

Latuda® (lurasidone HCl) Bipolar Depression - Adult Patient-Reported Functional Outcomes: Monotherapy Chart

Latuda® (lurasidone HCl) Bipolar Depression - Adult Patient-Reported Functional Outcomes: Monotherapy Chart

 

*Last observation carried forward (LOCF) analysis.
SDS=Sheehan Disability Scale.
Scale range, 0-30, with higher scores indicating greater impairment.
Mean baseline SDS scores: placebo: 19.8; LATUDA 20-60 mg/day: 19.7, LATUDA 80-120 mg/day:19.8.


Patient-reported quality of life 

Improvement in patient-reported quality of life at Week 6 (Q-LES-Q-SF score) versus placebo4,8*

Latuda® (lurasidone HCl) Bipolar Depression - Adult Patient-Reported Quality of Life: Monotherapy Chart

Latuda® (lurasidone HCl) Bipolar Depression - Adult Patient-Reported Quality of Life: Monotherapy Chart

 

*Last observation carried forward (LOCF) analysis.
Q-LES-Q-SF=Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form.
Scale range, 14-70, with higher scores indicating better quality of life.
Mean baseline Q-LES-Q-SF scores: placebo: 34.2; LATUDA 20-60 mg/day: 33.8, LATUDA 80-120 mg/day: 33.5.

 

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.

PRIMARY ENDPOINT: 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.


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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. 2014;171(2):169-177.
  2. Latuda® (lurasidone HCl) prescribing information. Sunovion Pharmaceuticals Inc. March 2018.
  3. Cucchiaro J. A Randomized, 6-week, double-blind, placebo-controlled, flexible-dose, parallel-group study of lurasidone adjunctive to lithium or divalproex for the treatment of bipolar I depression. Clinical Study Report D1050235. July 2012.
  4. 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.
  5. Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11(suppl 3):89-95.
  6. Stevanovic D. Quality of Life Enjoyment and Satisfaction Questionnaire-short form for quality of life assessments in clinical practice: a psychometric study. J Psychiatr Ment Health Nurs. 2011;18:744-750.
  7. Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-326.
  8. 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. 2014;171(2):160-168. 

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.