NUEDEXTA® is the first and only FDA-approved treatment for pseudobulbar affect (PBA). NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor that enables dextromethorphan to reach therapeutic concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain and spinal cord. The mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological 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 patient's underlying emotional state. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). In the STAR pivotal clinical trial, the primary outcome measure, number of laughing and crying episodes, was significantly lower in patients treated with NUEDEXTA compared with placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater reduction in the mean CNS-LS score from baseline for the NUEDEXTA treated patients compared with placebo. NUEDEXTA has not been tested in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.

For more information please visit the NUEDEXTA Website.

About PBA

A variety of neurological diseases and brain injury can cause pseudobulbar affect, or PBA. PBA is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state. It is believed that PBA outbursts result from a "short circuit" in the brain caused by conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, dementia and traumatic brain injury, to name a few. PBA can have a debilitating impact on the lives of patients, caregivers and loved ones. For more information about PBA, please visit www.PBAinfo.org.

Important Safety Information

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules are approved for the treatment of pseudobulbar affect (PBA). PBA is a medical condition that can occur in patients with certain underlying neurologic conditions and causes involuntary, sudden, and frequent episodes of laughing and/or crying.

NUEDEXTA can interact with other medications, causing significant changes in how those medications or NUEDEXTA may affect you. Tell your doctor about all medications and supplements you are taking before taking NUEDEXTA. While taking NUEDEXTA, do not start any new medications without first talking with your doctor. Ask your doctor what medications you cannot use with NUEDEXTA.

An allergic reaction to NUEDEXTA could occur. Seek medical attention immediately if you develop symptoms of an allergic reaction such as swelling of the throat and tongue, difficulty breathing, abnormal heart rate or rhythm (arrhythmia), dizziness, fever, rash, or hives after taking NUEDEXTA.

NUEDEXTA may cause serious side effects, including changes in heart rhythm. Tell your doctor if you or a family member currently have or have ever had any heart disease or problems. If you have certain heart problems or if currently taking certain other medications, NUEDEXTA may not be appropriate for you, or your doctor may want to monitor your heart rate when you start NUEDEXTA.

NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken.

The most common side effects of NUEDEXTA include diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence. Tell your doctor immediately if you feel faint or lose consciousness after taking NUEDEXTA. Tell your doctor about any side effect that bothers you or does not go away.

Take NUEDEXTA exactly as your doctor tells you. If you forget to take 1 or more capsules, do not take a double dose. Take your next dose of NUEDEXTA in the prescribed amount at the usual time. Do not take more than 2 capsules in a 24-hour period. Make sure that approximately 12 hours passes between doses.

Do not share NUEDEXTA or give it to others, even if they have the same symptoms as you. Tell your doctor if your PBA outbursts continue or get worse. Keep NUEDEXTA and all medications out of reach of children and pets.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For full prescribing information please visit the NUEDEXTA website.