Jill, female patient with PBA in her 50s Jill, female patient with PBA in her 50s

Efficacy

Proven to reduce PBA
episodes in clinical trials1

Discuss NUEDEXTA as a treatment option for your patients with Pseudobulbar Affect (PBA)1

Jill, patient living with PBA

PRIMARY ENDPOINT: STAR TRIAL1

FOR PATIENTS WITH ALS AND MS1

NUEDEXTA significantly reduced PBA episodes of crying and laughing1

Reduction in daily PBA episodes (mean change from baseline)1

Line graph representing the reduction in daily PBA episodes (-3.9 for NUEDEXTA vs -3.0 for placebo). Down arrow icon representing that, at week 12, people had 3.9 fewer daily episodes. Line graph representing the reduction in daily PBA episodes (-3.9 for NUEDEXTA vs -3.0 for placebo). Down arrow icon representing that, at week 12, people had 3.9 fewer daily episodes.

Safety: The most common adverse effects were diarrhea and dizziness.1

Study design: The pivotal trial was a 12-week, randomized, placebo-controlled study of 326 patients with amyotrophic lateral sclerosis (n=197) or multiple sclerosis (n=129) and clinically significant PBA. Patients received NUEDEXTA dextromethorphan 20 mg/quinidine 10 mg (n=107), placebo (n=109), or dextromethorphan 30 mg/quinidine 10 mg (unapproved dose [n=110]) twice daily (once daily in week 1). The baseline daily PBA episode rates were 6.8 in the NUEDEXTA dextromethorphan 20 mg/quinidine 10 mg group and 4.5 in the placebo group.1,2

SECONDARY ENDPOINT: STAR TRIAL2

Remission rates for patients treated with NUEDEXTA vs placebo

Percent of patients with zero episodes during the final 2 weeks2†

Bar chart representing the percentage of patients with zero PBA episodes during the final 2 weeks of the clinical trial (51% for NUEDEXTA and 29% for placebo) Bar chart representing the percentage of patients with zero PBA episodes during the final 2 weeks of the clinical trial (51% for NUEDEXTA and 29% for placebo)

†Remission was defined by the absence of episodes throughout the final 2 weeks of the study.2

Safety: The most common adverse effects were diarrhea and headache.3

THE PRISM II OPEN-LABEL STUDY: For patients with stroke, dementia, and traumatic brain injury3

PRIMARY ENDPOINT
Checklist icon Checklist icon

Patient-reported PBA symptom score changed by -7.7

Patients were asked to rate the frequency and severity of their PBA episodes (as assessed by CNS-LS score)

DayScore, mean (SD)
0 (n=298)20.4 (4.4)
30 (n=297)15.0 (5.0)
90/final visit (n=261)12.8 (5.0)
SECONDARY ENDPOINT
Two arrows (pointing in opposite directions) icon Two arrows (pointing in opposite directions) icon

Weekly episode rate changed from 12 to 2

Weekly median PBA episode rate‡

DayEpisodes
0 (n=298)12
30 (n=297)4
90/final visit (n=261)2

‡Measured as PBA episode counts over the 7 days prior to each visit (baseline, day 30, and day 90).3

 CNS-LS=Center for Neurologic Study-Lability Scale.

Study design: A 90-day, open-label trial of 367 patients with stroke, dementia, or traumatic brain injury. Patients received 1 capsule of NUEDEXTA per day during week 1 and were titrated to 1 capsule twice a day for week 2 through day 90.3

Study limitation: Open-label study without active placebo or comparator, utilizing self-reported measures. The CNS-LS has not been validated in stroke, dementia, or traumatic brain injury. Results require cautious interpretation.3

CNS-LS is a self-administered questionnaire, designed to be completed by the patient with a 7-item rating scale that measures perceived frequency and severity of PBA episodes. It was validated as a screening tool in amyotrophic lateral sclerosis and multiple sclerosis populations. A CNS-LS score of ≥13 may suggest but does not confer a PBA diagnosis.2,3

Interested in how to prescribe NUEDEXTA? Learn more about dosing and treatment.

dosing & treatment
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10-day sample

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  • References: 1.

    Nuedexta. Package insert. Otsuka America Pharmaceutical, Inc.; 2022.

  • 2.

    Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68(5):693-702. doi:10.1002/‌‌‌ana.22093

  • 3.

    Hammond FM, Alexander DN, Cutler AJ, et al. PRISM II: an open-label study to assess effectiveness of dextromethorphan/‌quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury. BMC Neurol. 2016;16:89. doi:10.1186/‌s12883-016-0609-0

IMPORTANT SAFETY INFORMATION and INDICATION for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Quinidine and Related Drugs: NUEDEXTA contains quinidine and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine.
  • Hypersensitivity: NUEDEXTA is contraindicated in patients with a history of NUEDEXTA-, quinine-, mefloquine-, or quinidine-induced thrombocytopenia, hepatitis, bone-marrow depression, lupus-like syndrome, or known hypersensitivity to dextromethorphan (e.g., rash, hives).
  • MAOIs: NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), or in patients who have taken MAOIs within the preceding 14 days, due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome. Allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
  • Cardiovascular: NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, heart failure, patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block.

Thrombocytopenia and Other Hypersensitivity Reactions: Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Non-specific symptoms, such as lightheadedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia. NUEDEXTA should be discontinued immediately if thrombocytopenia occurs.

Hepatotoxicity: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy. Discontinue immediately if this occurs.

Cardiac Effects: NUEDEXTA causes dose-dependent QTc prolongation. QT prolongation can cause torsades de pointes-type ventricular tachycardia, with the risk increasing as the degree of prolongation increases. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3 to 4 hours after the first dose. Some risk factors include use with CYP3A4 inhibitors or drugs that prolong QT interval, electrolyte abnormalities, bradycardia, or left ventricular hypertrophy or dysfunction. If patients taking NUEDEXTA experience symptoms that could indicate the occurrence of cardiac arrhythmias (e.g., syncope or palpitations), NUEDEXTA should be discontinued, and the patient further evaluated.

Concomitant Use of CYP2D6 Substrates: NUEDEXTA inhibits CYP2D6 and may interact with other drugs metabolized by CYP2D6. Adjust dose of CYP2D6 substrates as needed.

Dizziness: NUEDEXTA may cause dizziness. Take precautions to reduce the risk of falls.

Serotonin Syndrome: Use of NUEDEXTA with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk of “serotonin syndrome.”

Anticholinergic Effects of Quinidine: Monitor for worsening in myasthenia gravis.

Adverse Reactions: The most common adverse reactions (incidence of ≥3% and two-fold greater than placebo) in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.

These are not all the risks for use of NUEDEXTA.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/‌medwatch).

INDICATION

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurologic disease or injury.

Please see FULL PRESCRIBING INFORMATION.