Efficacy | NUEDEXTA® | Pseudobulbar Affect Treatment| HCP Site

CLINICAL TRIAL RESULTS DEMONSTRATE EFFICACY OF NUEDEXTA¹

Actor portrayal of patient with Pseudobulbar Affect, or PBA, without symptoms

NUEDEXTA Can Help Reduce Pseudobulbar Affect (PBA) Episodes¹

THE STAR PIVOTAL TRIAL: For Patients with ALS and MS

NUEDEXTA significantly reduced PBA episode rates compared with placebo in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).¹

PRIMARY ENDPOINT: STAR TRIAL¹

NUEDEXTA significantly reduced PBA episodes of laughing and crying¹

Reduction in daily PBA episodes (mean change from baseline)²

*P=0.0048 vs placebo.²

Study design: The pivotal trial was a 12-week, randomized, placebo-controlled study in patients with ALS or MS and clinically significant PBA. The trial included patients receiving NUEDEXTA dextromethorphan  20 mg/quinidine 10 mg (n=107) and patients receiving placebo (n=109) twice daily (once daily in week 1).²

Read the full study design here and safety information here.

SECONDARY ENDPOINT: STAR TRIAL²

Remission rates for patients treated with NUEDEXTA vs placebo

Percent of patients with zero episodes during the final 2 weeks^2†

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

THE PRISM II OPEN-LABEL STUDY: For patients with stroke, dementia, and traumatic brain injury (TBI)

The Center for Neurologic Study-Lability Scale (CNS-LS) score in all cohorts combined decreased from 20.4 at baseline to 12.8 at day 90. CNS-LS reductions were similar across the dementia, stroke, and TBI cohorts, with a range of 7.2 to 8.5 at day 90.³

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

Study design: A 90-day, open-label trial of 367 patients with stroke, dementia, or traumatic brain injury. The dosing regimen was the same as the pivotal trial.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

Read the full study design here and safety information here.

Learn about prescribing NUEDEXTA for patients with PBA at Dosing and Treatment page.

Co-Pay Card & Sample Requests

CO-PAY SAVINGS CARD

Share this card to help your patients save on their NUEDEXTA prescription and refills. By enrolling, your commercially insured patients may pay as little as $0 for a 90-day supply, or $20 for a 30-day supply.

Print Co-Pay Savings Card Restrictions apply. Most commercially insured patients pay as little as $0 for a 90-day supply or $20 for a 30-day supply. Benefit cap applies regardless of co-pay amount.

NUEDEXTA sample bottle for PseudoBulbar Affect (PBA) patients

REQUEST SAMPLES

Eligible healthcare providers can request a free 10-day sample of NUEDEXTA for appropriate patients.

Request a Sample

References: 1. NUEDEXTA [package insert]. Rockville, MD: Otsuka America Pharmaceutical, Inc. 2022. 2. Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra-low quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68(5):693-702. 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).

Please see FULL PRESCRIBING INFORMATION.

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.