Every year, more than 795,000 people in the U.S. have a stroke, the leading cause of serious long-term disability.1 The risk for stroke increases with age1; people over the age of 65 account for nearly three-quarters of all strokes that occur, with the risk of having a stroke more than doubling each decade after the age of 55.2 As the aging population continues to grow, so does the number of people at risk for stroke.
According to a national registry of 757 post stroke patients, 38 percent had symptoms suggestive of another neurological condition known as PseudoBulbar Affect (PBA), which can occur secondary to neurologic conditions such as stroke.3 Based on this prevalence data, about a quarter of a million people in the U.S. who have suffered a stroke may also have PBA.4
Because people recovering from a stroke are often concerned with regaining lost function—and preventing another stroke—it may be easy to overlook sudden, frequent crying and/or laughing symptoms or mistake them for depression.5 If you have had a stroke and have experienced such symptoms that are impacting your life, talk to your doctor and describe these symptoms, as this could be PBA.
What Is PBA?
PBA is a condition that results in sudden, frequent and uncontrollable episodes of crying and/or laughing that don’t match how you feel. It is thought to affect about two million people in the U.S. who suffer from common neurologic diseases or brain injuries, and can affect men and women.6
PBA is a distinct condition that can happen in people secondary to a core neurologic condition such as stoke, traumatic brain injury (TBI), Alzheimer’s disease (AD) and dementia, multiple sclerosis (MS), Parkinson’s or amyotrophic lateral sclerosis (ALS). In people with these conditions, damage can be caused that disrupts the signals that tell a person’s body when or how much to cry or laugh. These sudden episodes are often exaggerated (more intense or lasting longer than expected) or mismatched (not fitting the situation).5
PBA Is Not Depression
Although symptoms of PBA may be mischaracterized as depression, PBA and depression are two separate conditions, and can be independently diagnosed. These conditions can coexist and are both treatable.6
There is a medication that has been approved by the FDA for the treatment of PBA called NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate). It is the first and only FDA-approved treatment for PBA.7
In a 12-week clinical trial, NUEDEXTA was proven to significantly reduce PBA episodes. Compared to baseline, patients had an average of 44 percent fewer PBA episodes after the first week of taking NUEDEXTA (versus 19 percent taking placebo). After completing 12 weeks on therapy, patients had 82 percent fewer episodes compared to baseline (versus 45 percent taking placebo). Additionally, 51 percent of patients were completely free of PBA episodes during the final two weeks of the study (versus 29 percent taking placebo).7
Talk To Your Doctor
If you or someone you care for has a brain injury or neurologic condition and experiences frequent, unexpected, and uncontrollable episodes of crying and/or laughing that do not match how the person feels, talk to your doctor, as it could be PBA.
In the meantime, you can take a short assessment at www.nuedexta.com/do-i-have-pba-assessment. Your answers may help you start a conversation with your doctor.8
What is NUEDEXTA® approved for?
Important Safety Information
Before you take NUEDEXTA, tell your doctor:
While taking NUEDEXTA, call your doctor right away:
The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA.
DO NOT TAKE NUEDEXTA IF YOU
NUEDEXTA MAY CAUSE SERIOUS SIDE EFFECTS
POSSIBLE COMMON SIDE EFFECTS OF NUEDEXTA
The most common side effects in patients taking NUEDEXTA were diarrhea, dizziness, cough, vomiting, weakness and swelling of feet and ankles.
TAKING NUEDEXTA ALONG WITH OTHER MEDICATIONS
ADDITIONAL IMPORTANT INFORMATION
NEED MORE INFORMATION?
This information about NUEDEXTA is important but is not complete. To learn more:
NEED PRESCRIPTION ASSISTANCE?
©2016 Avanir Pharmaceuticals, Inc. All rights reserved.
NUEDEXTA is a registered trademark of Avanir Pharmaceuticals, Inc.
1 Stroke Facts. Centers for Disease Control and Prevention. http://www.cdc.gov/stroke/facts.htm. Accessed September 26, 2016.
2 Stroke Statistics. The Internet Stroke Center. http://www.strokecenter.org/patients/about-stroke/stroke-statistics/. Accessed September 26, 2016.
3 The PRISM Registry was a nationwide study of adult patients with Alzheimer’s disease (1799), amyotrophic lateral sclerosis-ALS(125), multiple sclerosis-MS (1215), Parkinson’s disease (804), stroke (757) or traumatic brain injury-TBI (590). PBA symptoms were defined as a Center for Neurologic Study Lability Scale (CNS-LS) score >= 13. This CNS-LS score may suggest PBA symptoms and merits further diagnostic assessment. Patients or caregivers completed the assessment.
4 Work SS, Colamonico JA, Bradley WG, Kaye RE. Pseudobulbar affect: an under-recognized and under-treated neurological disorder. Adv Ther. 2011;28:586–601.
5 PBA vs. Depression. NUEDEXTA.com. https://www.nuedexta.com/about-pba/pba-vs-depression. Accessed September 26, 2016.
6 About PseudoBulbar Affect (PBA). NUEDEXTA.com. https://www.nuedexta.com/about-pba. Accessed September 26, 2016.
7 Results vs baseline from a 12-week, double-blind, clinical study that evaluated the safety and efficacy of NUEDEXTA (N=107) for the treatment of PBA in ALS and MS patients. Patients on placebo (N=109) experienced a 19% reduction in PBA episodes at Week 1 and a 45% reduction in PBA episodes at Week 12 compared to baseline.
8 Do I have PBA? (PseudoBulbar Affect or PBA). NUEDEXTA. https://www.nuedexta.com/do-i-have-pba. Accessed September 26, 2016.