NUEDEXTA is the only FDA-approved, clinically proven treatment for PBA1

Actor portrayal of a patient with PseudoBulbar Affect (PBA) without symptoms

Pseudobulbar affect (PBA) causes uncontrollable laughing and/or crying that happens suddenly and is unpredictable. As a result, many patients worry about having an episode in public—and they feel uncomfortable in social settings. But the disorder is manageable and NUEDEXTA can help.1,2

The efficacy and safety of NUEDEXTA were evaluated in two clinical trials1,3,4

Results of Nuedexta Phase 3 Pivotal Trial
Pivotal Trial

Phase 3, double-blind, placebo-controlled study in patients with PBA secondary to amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS)3

NUEDEXTA significantly reduced PBA episode rates compared with placebo at Week 1 and throughout the 12-week pivotal trial5
  • At Week 12, -3.9 mean change in daily PBA episode rate (6.8 baseline) vs -3.0 (4.5 baseline) for placebo (P=0.005)1,3
  • Complete PBA episode remission was achieved by 51% of patients on NUEDEXTA vs 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
Pivotal Trial Study Design
Results of Nuedexta Phase 4 PRISM II study
PRISM II

Phase 4, open-label study 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 TBI5
  • 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
PRISM II Study Design
Adverse events in Nuedexta clinical trials

Adverse events were generally consistent across clinical trials and mild to moderate in nature1,4

Patients describe PBA treatment in their own words

These short videos of real patients reveal how treatment with NUEDEXTA helped reduce their PBA episodes.

A real patient with TBI talks about treatment for PBA
Listen to a 43-year-old mother of two talk about treatment with NUEDEXTA.
A real resident who suffered a stroke talks about treatment for PBA
Listen to a 75-year-old stroke survivor talk about NUEDEXTA and her reduction in PBA episodes.
Nuedexta dosing titration
Dosing

Titrate from 1 capsule once daily to 1 capsule every 12 hours on Day 8.1 Efficacy beyond Week 1 in the pivotal trial was achieved with Q12H dosing.5

  • Following this regimen, patients on NUEDEXTA had a mean 82% reduction in PBA episodes vs 45% on placebo at 12 weeks in the STAR pivotal trial5
  • The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA symptoms occurs in some patients

More Dosing Information

References: 1. NUEDEXTA [package insert]. Aliso Viejo, CA: Avanir Pharmaceuticals, Inc. 2. Pseudobulbar affect. National Institutes of Health website. https://rarediseases.info.nih.gov/diseases/12012/pseudobulbar-affect. Accessed June 29, 2019. 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. Brooks BR, Crumpacker D, Fellus J, Kantor D, Kaye RE. PRISM: a novel research tool to assess the prevalence of pseudobulbar affect symptoms across neurological conditions. PLoS ONE. 2013;8(8):e72232. 7. 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. 8. 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. 9. Smith RA, Berg JE, Pope LE, Thisted RA. Measuring pseudobulbar affect in ALS. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5(suppl 1):99-102.

INDICATION AND USAGE

NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) 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 (eg, 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 (eg, thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block.

WARNINGS AND PRECAUTIONS

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 (eg, 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. Please see Full Prescribing Information.

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