NUEDEXTA SAFETY & EFFICACY

Actor portrayal of a patient with Pseudobulbar Affect, or PBA, crying symptoms

NUEDEXTA is the first and only FDA-approved treatment for Pseudobulbar Affect (PBA)1

 
NUEDEXTA is clinically proven to reduce PBA episodes and has a demonstrated safety profile.1,3,5

PBA causes uncontrollable laughing and/or crying that happens suddenly. Because episodes are unpredictable, many patients worry about having an episode in public — and they may feel uncomfortable in social settings. But the disorder is manageable and NUEDEXTA can help reduce their daily episodes.1,2

 
Reducing PBA episodes can make a difference.

For patients with PBA, each episode can have an impact. In one web-based survey (N=1,052) of patients with an underlying neurologic condition associated with PBA or their nonpaid caregivers, respondents who described their uncontrollable laughing and/or crying episodes as “extremely” or “very” burdensome had experienced an average of 8.8 crying episodes or 4.6 laughing episodes in the past week.8 Patients with PBA symptoms (N=399) were defined as those who scored 13 or greater on the Center for Neurologic Study-Lability Scale (CNS-LS).*

*The CNS-LS was validated as a measure of perceived episode frequency in amyotrophic lateral sclerosis and multiple sclerosis populations. The scale does not confer a PBA diagnosis.6,7

 
A Real Patient’s Treatment Story

Learn about the impact of reducing PBA episodes with NUEDEXTA.

Video play icon over real patient with TBI video
A real patient with TBI talks about treatment with NUEDEXTA
“I won’t cry at a family party that was really emotional to me…[before treatment] I’d pretty much cry walking in.”
Download a transcript of this video.

NUEDEXTA’s Safety And Efficacy Were Evaluated In Two Clinical Trials

Graph icon representing STAR Pivotal Trial
The STAR Pivotal Trial

The STAR Pivotal trial was a phase 3, double-blind, placebo-controlled study (N=326) in patients with PBA secondary to amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).3

NUEDEXTA significantly reduced PBA episode rates compared with placebo in the 12-week Pivotal trial5
Upside down arrow with text week 12 3.9 fewer episodes per day from 6.8 at baseline
Efficacy:
  • At Week 12, patients on NUEDEXTA experienced a 3.9 mean reduction in the daily PBA episode rate (6.8 baseline) versus a 3.0 mean reduction (4.5 baseline) for those on placebo (P=0.005).1,3
  • In a post-hoc analysis, NUEDEXTA significantly reduced PBA episodes rates compared to placebo starting at Week 1.
  • Complete PBA episode remission was achieved by 51% of patients on NUEDEXTA versus 29% on placebo by Week 12 (P<0.005).3 Remission was a secondary outcome, defined as the absence of PBA episodes during the patient’s final 14 days of participation in the 12-week study.
Safety:
Chart icon representing PRISM II study
The PRISM II Study

The PRISM II study was a phase 4, open-label study (N=367) in patients with PBA secondary to stroke, dementia, or traumatic brain injury (TBI).4

NUEDEXTA reduced PBA symptom scores and episode rates in patients with stroke, dementia, and TBI.5
Upside down arrow with text week 12 7.7 point decrease in CNS-LS score overall from 20.4 at baseline.
Efficacy:
  • At Day 90 of the PRISM II study, patients’ mean Center for Neurologic Study-Lability Scale (CNS-LS) score decreased by 7.7 points from 20.4 at baseline (P<0.001).4
  • Overall, patients started with about 12 episodes per week at baseline and 2 by Week 12.4
Safety:

Safety and Efficacy Pocket Guide

Keep NUEDEXTA’s safety and efficacy profile handy with a pocket guide. Download Now

 

NUEDEXTA is the first and only FDA-approved treatment for PBA.1 Explore the pages below to learn more about treating PBA with NUEDEXTA.

 

 

Efficacy Icon

Efficacy

Review the efficacy data from NUEDEXTA’s clinical studies.

Safety Icon

Safety

Read about NUEDEXTA’s safety profile.

Dosing Icon

Dosing

Learn how to prescribe NUEDEXTA for your patients with PBA.

Co-Pay Card & Sample Requests
Example image of Nuedexta savings card

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. 2. Pseudobulbar affect. National Institutes of Health website. https://rarediseases.info.nih.gov/diseases/12012/pseudobulbar-affect. Accessed July 7, 2021. 3. Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra-low quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68(5):693-702. 4. 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. 5. Data on file. Avanir Pharmaceuticals, Inc. 6. Moore SR, Gresham LS, Bromberg MB, Kasarkis EJ, Smith RA. A self report measure of affective lability. J Neurol Neurosurg Psychiatry. 1997;63(1):89-93. 7. Smith RA, Berg JE, Pope LE, Callahan JD, Wynn D, Thisted RA. Validation of the CNS emotional lability scale for pseudobulbar affect (pathological laughing and crying) in multiple sclerosis patients. Mult Scler. 2004;10(6):679-685. 8. Colamonico J, Formella A, Bradley W. Pseudobulbar affect: burden of illness in the USA. Adv Ther. 2012;29(9):775-798.

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

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.

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.