A Lesser-Known Neurologic Condition Related to Traumatic Brain Injury: What to Know

(BPT) – Approximately 2.3 million people in the U.S. have suffered from a traumatic brain injury (TBI).¹ According to a study published in Advances in Therapy which included 326 TBI patients, nearly half (48.2 percent) had symptoms suggestive of a neurologic condition known as PseudoBulbar Affect (PBA), which can occur secondary to neurologic conditions such as TBI.¹ Based on this prevalence data, over 1 million people in the U.S. who have had a TBI may also have PBA.¹

TBI affects everyone differently. Some experience PBA symptoms of frequent, uncontrollable crying and/or laughing very soon after their injury. While for others, these symptoms may not be recognized until some months after their TBI during the recovery process. Some never experience PBA at all.² If you have suffered from a TBI 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.² It is thought to affect about two million people in the U.S. who suffer from common neurologic diseases or traumatic brain injuries, and can affect men and women.¹

PBA is a distinct condition that can happen in people secondary to a core neurologic condition such as TBI, stroke, Alzheimer’s disease (AD) and dementia, multiple sclerosis (MS), Parkinson’s or amyotrophic lateral sclerosis (ALS). In people with these conditions, the signals that tell a person’s body when or how much to cry or laugh are disrupted. These sudden episodes are often exaggerated (more intense or lasting longer than expected) or mismatched (not fitting the situation).²

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.³

Treating PBA

There is a medication called NUEDEXTA^® (dextromethorphan hydrobromide and quinidine sulfate) that is the first and only FDA-approved treatment for PBA.⁴

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 of 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).^5,6

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, ask your doctor if it could be PBA.

In the meantime, you can take a short quiz at www.nuedexta.com. Your answers may help you start a conversation with your doctor.⁷

What is NUEDEXTA^® approved for?

• NUEDEXTA^® is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from emotional changes caused by neurologic disease or injury.
• NUEDEXTA is only available by prescription.

Important Safety Information

Before you take NUEDEXTA, tell your doctor:

• If you are taking monoamine oxidase inhibitors (MAOIs), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.
• If you have previously had an allergic reaction to dextromethorphan, quinidine or quinidine-like drugs.
• About all medicines, herbal supplements, and vitamins you take as NUEDEXTA and certain other medicines can interact causing side effects.
• If you have had heart disease or have a family history of heart rhythm NUEDEXTA may cause serious side effects, including changes in heart rhythm. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.
• If you have myasthenia gravis.

While taking NUEDEXTA, call your doctor right away:

• If you feel faint or lose consciousness.
• If you experience lightheadedness, chills, fever, nausea, or vomiting as these may be signs of an allergic reaction to NUEDEXTA. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.
• If you have unexplained bleeding or bruising. Quinidine, an ingredient in NUEDEXTA, can cause a reduction in the number of platelets in your blood which can be severe and, if left untreated, can be fatal.
• If you feel dizzy, since it may increase your risk of falling.
• If you have muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, or shivering, as these may be signs of a potential drug interaction called serotonin syndrome.

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. Visit www.fda.gov/medwatch or call 800-FDA-1088.

IMPORTANT FACTS

ABOUT NUEDEXTA

• NUEDEXTA^® is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.
• NUEDEXTA is only available by prescription.

DO NOT TAKE NUEDEXTA IF YOU

• Are taking other drugs that contain quinidine, quinine, or mefloquine.
• Have a history of allergic reactions or intolerance (including hepatitis, low blood cell count, or lupus-like syndrome) to quinidine, quinine, or mefloquine.
• Have ever been allergic to dextromethorphan (commonly found in some cough medicines).
• Are taking, or have taken, drugs called monoamineoxidase inhibitors (MAOIs). MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.
• Have had heart disease or have a family history of heart rhythm problems.
• Are taking drugs such as thioridazine and pimozide that interact with NUEDEXTA and cause changes in heart rhythm.

If you have certain heart conditions or are taking certain medicines, your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.

NUEDEXTA MAY CAUSE SERIOUS SIDE EFFECTS

• Stop NUEDEXTA if these side effects occur:
  • Symptoms including lightheadedness, chills, fever, nausea, or vomiting may be a sign of an allergic reaction, or thrombocytopenia which if left untreated can be fatal.
  • Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.
  • Abnormal heart rhythm. Stop NUEDEXTA and tell your doctor immediately as it may be a sign of Torsadesde Pointes.
• In some cases NUEDEXTA can interact with antidepressants causing confusion, high blood pressure, fever, restlessness, sweating, and shivering. Tell your doctor if you experience any of these side effects.
• Tell your doctor if you’ve ever been diagnosed with myasthenia gravis. If so, NUEDEXTA may not be right for you.

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.

• If you are unsteady on your feet or if you have fallen before, be careful while taking NUEDEXTA to avoid falling.
• This is not a complete list of side effects.
• Tell your doctor if you have any side effect that bothers you or does not go away.

TAKING NUEDEXTA ALONG WITH OTHER MEDICATIONS

• Tell your doctor about all medicines, supplements, and vitamins you take before starting NUEDEXTA.
  
• NUEDEXTA may interact with other medications causing potentially serious side effects, and may affect the way NUEDEXTA or these other medicines work. Your doctor may adjust the dose of these medicines if used together with NUEDEXTA:
  • Antidepressants.
  • Certain heart or blood pressure medications. Your doctor may test your heart rhythm before you start NUEDEXTA.
  • Digoxin.
  • Limit alcohol intake while taking NUEDEXTA.
• These are not the only medicines that may cause problems when you take NUEDEXTA.
• Before starting a new medicine, remind your doctor if you are taking NUEDEXTA.

ADDITIONAL IMPORTANT INFORMATION

• If your PBA symptoms do not improve or if they get worse, contact your healthcare provider.
• NUEDEXTA has not been studied in patients less than age 18 or in pregnant women. Tell your doctor if you may be pregnant.
• Nursing mothers: Because many drugs are excreted in human milk, discuss with your healthcare provider if you are nursing.
• Take NUEDEXTA exactly as your doctor prescribes it.
• You and your healthcare provider should talk regularly about whether you still need treatment with NUEDEXTA.
• NUEDEXTA may be taken with or without food.
• Keep NUEDEXTA and all medicines out of reach of children.
• The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA occurs in some patients.

NEED MORE INFORMATION?

This information about NUEDEXTA is important but is not complete. To learn more:

• Talk to your healthcare provider or pharmacist.
• Visit www.Nuedexta.com for FDA-approved Prescribing Information or call 1-855-4NUEDEX (1-855-468-3339).

NEED PRESCRIPTION ASSISTANCE?

• Call 1-855-4NUEDEX (1-855-468-3339) to speak with a member of our support team for tips, tools and co-pay information.

©2017 Avanir Pharmaceuticals, Inc. All rights reserved.

NUEDEXTA is a registered trademark of Avanir Pharmaceuticals, Inc.

2 What is PBA? NUEDEXTA.com. https://www.nuedexta.com/what-is-pba. Accessed January 25, 2017.

3 How is PBA different from Depression? NUEDEXTA.com. https://www.nuedexta.com/pba-vs-depression. Accessed January 25, 2017.

4 How NUEDEXTA can help. NUEDEXTA.com. https://www.nuedexta.com/treating-pba/how-nuedexta-can-help. Accessed January 25, 2017.

5 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.

6 Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.

7 Do you have PBA? NUEDEXTA.com. https://www.nuedexta.com/do-you-have-pba. Accessed January 25, 2017.