CLINICAL TRIAL RESULTS DEMONSTRATE NUEDEXTA EFFICACY

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

NUEDEXTA Can Help Reduce Pseudobulbar Affect (PBA) Episodes After 90 Days.1-3,7

 
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).1,2

Upside down arrow with text 3.9 fewer episodes per day from 6.8 baseline

The STAR Pivotal clinical trial was a randomized, placebo-controlled study of 326 patients researching NUEDEXTA’s efficacy.1,2

A change in the number of PBA episodes per day was the primary endpoint of the Pivotal clinical trial. 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 versus placebo).1,2

Post hoc analysis: Episode rate reduction from baseline in the 12-week Pivotal clinical trial3

Over 90 days, patients on NUEDEXTA experienced fewer PBA episodes, with a reduction of 82% at Week 12. Patients received NUEDEXTA once daily in Week 1 and once every 12 hours starting at Day 8.2

Line graph depicting the decrease in episodes over a period of 90 days while taking NUEDEXTA

 

Secondary outcomes showed significant improvement with NUEDEXTA versus the placebo2

At Week 12, the mean Center for Neurologic Study-Lability Scale (CNS-LS) score decreased by 8.2 points for patients on NUEDEXTA from a 21.0 baseline versus 5.7 points for patients on placebo from a 19.9 baseline (P=0.0113).1,2

*The CNS-LS is a seven-item self-report rating scale that measures perceived frequency and control over laughing and/or crying episodes. It was validated as a PBA screening tool in ALS and MS. A CNS-LS score of 13 or greater may suggest PBA but does not confer a PBA diagnosis.5,6

51% OF PATIENTS ACHIEVED REMISSION

Complete episode remission was achieved by 51% of patients on NUEDEXTA compared with 29% of patients on a placebo (P<0.005).2

Remission was defined as the absence of PBA episodes during the patient’s final 14 days of participation in the 12-week study.2

THE PRISM II OPEN-LABEL STUDY – For Patients with Stroke, Dementia, and TBI

Upside down arrow with text 7.7 point decrease in CNS-LS score overall from 20.4 at baseline

PRISM II was an open-label trial of 367 patients. Change in CNS-LS score was the primary endpoint.7

NUEDEXTA was effective in reducing PBA symptom scores and episode rates in patients with stroke, dementia, and TBI.7

The CNS-LS score in all cohorts combined decreased from 20.4 at baseline to 12.8 at Day 90 (P<0.001 versus baseline). CNS-LS reductions were similar across the dementia, stroke, and TBI cohorts, with a range of 7.2 to 8.5 at Day 90.7

Secondary endpoint: median change in number of PBA episodes per week from baseline7-10

Table graph depicting decrease in the number of PBA episodes per week over 90 days by underlying condition

Patients in the study experienced a sizable decrease in the number of PBA episodes per week after 90 days. Overall, patients started with about 12 episodes per week at baseline, 4 episodes by day 30, and 2 by day 90.

Interested in how to prescribe NUEDEXTA? Check out our Dosing and Treatment page.

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.  Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra-low quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68(5):693-702.  3.  Data on file. Avanir Pharmaceuticals, Inc.  4.  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.  5.  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.  6.  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.  7. 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. 8. Zorowitz RD, Alexander DN, Formella AE, et al. Dextromethorphan/quinidine for pseudobulbar affect following stroke: safety and effectiveness in the PRISM II trial. PM R. 2019;11(1):17-24. 9. Doody RS, D'Amico S, Cutler AJ, et al. An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results. CNS Spectr. 2016;21(6):450-459. 10. Hammond FM, Sauve W, Ledon F, Davis C, Formella AE. Safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect among study participants with traumatic brain injury: results from the PRISM-II open label study. PM R. 2018;10(10):993-1003.

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.