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Neudexta

Pseudobulbar Affect (PBA), a common symptom of several neurological conditions including ALS/MND. People affected by PBA experience sudden episodes of unintentional or involuntary crying and laughter without any emotional stimulus. The symptoms can cause embarrassment and it can disrupt daily life.

PBA is caused by damage to the nerve cells in the brain that control emotions. The drug Nuedexta modulates nerve cell activity in the brain, and it was approved to treat PBA in people with ALS/MND in the United States in 2010. Read on to learn more about Nuedexta’s pathway to approval.

Background

Nuedexta is an oral medication manufactured by Avanir Pharmaceuticals. After its approval in the US, Nuedexta received approval from the European Medicine Agency (EMA) but for commercial reasons, its approval was later withdrawn

How it Works

Nuedexta contains two active ingredients: dextromethorphan hydrobromide (DMX; the active ingredient in cough syrup) and quinidine sulfate. The drug acts on several different proteins throughout the body, and it is unclear exactly how it works to treat PBA. The quinidine component acts to increase the amount of DMX the body can use, but on its own, quinidine may also have beneficial effects that have not yet been discovered.

The dextromethorphan component is thought to activate certain cell receptors, such as sigma-1 receptors, which are critical for activating nerve cells. It may also inhibit receptors that suppress nerve cell activity, such as NMDA receptors. However, it is unclear how these two effects work together to reduce PBA symptoms in people with ALS/MND.

Although scientists do not know exactly how the drug works, Nuedexta has shown efficacy for treating PBA in multiple clinical trials. Since then, researchers have investigated Nuedexta’s potential as a treatment for other motor symptoms such as impaired speech and swallowing.

Nuedexta in Clinical Trials

Researchers must demonstrate the safety and efficacy of a drug before it can be approved for treatment. A randomized, double-blind, placebo-controlled clinical trial is considered the highest standard.

In these trials, participants are randomly assigned to one out of two or more groups. One group will receive a placebo, which does not contain the test drug. Other groups will receive a specific dose of the test drug.

“Double-blinded” means that neither the participants nor the researchers know who receives which treatment (drug vs placebo). This can prevent bias from affecting the results of the study.

Nuedexta underwent several such clinical trials, ultimately leading to US Food and Drug Administration (FDA) approval in 2010.

Study 1:

In the first pivotal clinical trial for Nuedexta, 140 people with ALS/MND and PBA were randomly assigned to one of three groups. Participants in one group received Nuedexta, while the others received either 30 mg of dextromethorphan or 30 mg of quinidine.

The drug was administered twice daily for 28 days and researchers measured peoples’ emotional outbursts on a scale from 7 (no symptoms) to 35 (many symptoms). If someone scores higher than 13 points, they receive a diagnosis of PBA.

In the trial, the people taking Nuedexta experienced lower rates of PBA episodes. They scored an average of 3.5 points lower on the symptom scale than those taking either dextromethorphan or quinidine alone. Participants taking Nuedexta also rated their quality of life and quality of relationships higher than those in the other two groups.

This trial was published in 2004 in Neurology, in an article titled, “Treatment of pseudobulbar affect in ALS with dextromethorphan/quinidine: a randomized trial.”

Study 2:

In a second randomized, double-blind, placebo-controlled clinical trial, 150 people with multiple sclerosis received a capsule of Nuedexta or placebo, twice daily for 85 days.

The researchers measured changes in PBA symptoms on the same scale as Study 1.

Nuedexta reduced scores by 7.7 points, on average, compared to placebo, which only reduced scores by 3.3 points.

These results were published in 2006 in an Annals of Neurology article titled, “Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis.”

Study 3:

In a third clinical trial, researchers compared two different compositions of Nuedexta. A total of 283 people with ALS/MND and PBA were assigned to one of three groups: Nuedexta containing 30 mg of DMX, Nuedextra containing 20 mg of DMX, or placebo. The treatments were administered twice daily for 12 weeks.

After the 12 weeks, participants receiving both compositions of Nuedexta cut PBA episodes by almost half compared to the placebo group. Furthermore, both compositions led symptoms scores to drop by 8.2 points on average, compared to placebo, which only led to a 5.7-point drop. Symptoms were more likely to go away in those who received Nuedexa, and the higher dose led to improved social functioning and mental health.

These results were published in the Annals of Neurology in an article titled, “Dextromethorphan plus ultra-low-dose quinidine reduces pseudobulbar affect.”

Dose and Administration

In its FDA-approved form, one capsule of Nuedexta contains 20 mg of dextromethorphan and 10 mg of quinidine. For treatment of PBA, people take Nuedexta once daily for seven days and then twice daily thereafter.

Reported Side Effects of Nuedexta

Nuedexta is a prescription medication that should be used in consultation with a physician. Common side effects can include diarrhea, dizziness, coughing, vomiting, fatigue, and urinary tract infections. In addition, there are reports of various drug interactions.

Do not take Nuedexta if you are taking MAO inhibitor drugs (e.g. Marplan, Parnate). Individuals with a medical history of certain disorders such as hepatitis, bone marrow depression, or thrombocytopenia may be more likely to experience complications in response to this medication. Therefore, people with ALS/MND should disclose their medical history and other medications to their healthcare team before using Nuedexta.

Current Status

Recently, Nuedexta gained attention for its potential benefits in treating other bulbar symptoms in ALS/MND, such as speech and swallowing impairments.

In 2017, researchers recruited 60 people with ALS/MND for a randomized, double-blind, cross-over clinical trial looking at if the drug could improve speech and swallowing and reduce drooling. People received Nuedexta or a placebo for 28 days then went off the drug for two weeks. Participants then switched treatment groups for another 28 days: the Nuedexta group switched to placebo and the placebo group switched to Nuedexta. The clinical trial showed promising results, but more research is warranted.

The results were published in a study titled, “Enhanced bulbar function in amyotrophic lateral sclerosis: the Nuedexta treatment trial” in Neurotherapeutics.

A clinical trial is currently ongoing to further investigate the effects of Nuedexta on speech and swallowing in people with ALS/MND. People enrolled in this study will receive one Nuedexta capsule  daily for 30 days.

Researchers are also investigating whether the drug can be effective at treating depression, bipolar disorder, Alzheimer’s disease, and autism. While clinical trials have shown promising results, Nuedexta is still only approved for the treatment of PBA, and only in the United States.

Disclaimer: Consult with your doctor to determine if Nuedexta is an option for you. Always disclose your medical history, including any drugs, natural supplements, or herbal medicines you are currently using. Your doctor will determine the right plan for your needs.

Primary Sidebar

Approved Drugs

  • Radicava/Edaravone
  • Neudexta

  • Joyce Rusinak, Forbes Norris ALS Center, USA

    Joyce Rusinak, Forbes Norris ALS Center, USA

  • Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013, Belgium

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  • Jo Knowlton and her dog, Scotland

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  • Liong Ting Ngu, MND Malaysia, Diagnosed 2014, Malaysia

    Liong Ting Ngu, MND Malaysia, Diagnosed 2014, Malaysia

  • Francisco Perez Palop, Diagnosed 2013 - FUNDELA, Spain

    Francisco Perez Palop, Diagnosed 2013 – FUNDELA, Spain

  • Inta Grubb, Diagnosed 2014 - MND Australia

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  • Marcel R. Wernard, Diagnosed 2016 - ALS Patients Connected, The Netherlands

    Marcel R. Wernard, Diagnosed 2016 – ALS Patients Connected, The Netherlands

  • England-Lee-Millard, UK

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  • Elkin Ramiro Gaviria Muñoz, Diagnosed  December 2018

    Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

  • Daniel Hare

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  • Sally Pauls, Diagnosed 2006 - Les Turner ALS Foundation

    Sally Pauls, Diagnosed 2006 – Les Turner ALS Foundation

  • Steve Lufkin, USA

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  • Claire Garry, USA

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  • Lachlan Terry, MND Australia, Diagnosed 2015, Australia

    Lachlan Terry, MND Australia, Diagnosed 2015, Australia

  • Christian Bär, Germany

    Christian Bär, Germany

  • Chun Ju Xiao, China

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  • Cath Muir

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  • Alejandro Aquino, Diagnosed 2011 - Asociación ELA Argentina

    Alejandro Aquino, Diagnosed 2011 – Asociación ELA Argentina

  • Philip Brindle, MND Association, Diagnosed 2015, England

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  • Peng Yi-Wen

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  • Jeff Sutherland

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  • Ali Var, Turkey

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  • Ian Roberts

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  • Phil Rossall, MND-Association, UK

    Phil Rossall, MND-Association, UK

  • Josée Kolijn-de Man, Diagnosed 2015 - ALS Patients Connected, The Netherlands

    Josée Kolijn-de Man, Diagnosed 2015 – ALS Patients Connected, The Netherlands

  • Len Johnrose, MND Association, Diagnosed 2017, England

    Len Johnrose, MND Association, Diagnosed 2017, England

  • Catherine Pearce, Australia

    Catherine Pearce, Australia

  • Willi Klein

    Willi Klein

  • Duncan Bayly - MND Australia

    Duncan Bayly – MND Australia

  • David Watson, MND Scotland, Diagnosed 2018, Scotland

    David Watson, MND Scotland, Diagnosed 2018, Scotland

  • Orlando Ruiz, Diagnosed 2001 - ACELA, Colombia

    Orlando Ruiz, Diagnosed 2001 – ACELA, Colombia

  • Chen Chun-Chin

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  • Ailsa Malcolm-Hutton, Diagnosed 2013 - MND Association of England, Wales and N Ireland

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  • Mark Miller

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  • Charlie “Hark” Dourney, Diagnosed 2007 - Hark ALS, USA

    Charlie “Hark” Dourney, Diagnosed 2007 – Hark ALS, USA

  • Monica Soriano, Diagnosed 2011 - Asociación ELA Argentina

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  • Roy

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  • Osiel Mendoza, Diagnosed 2016 - ALS Therapy Development Institute, USA

    Osiel Mendoza, Diagnosed 2016 – ALS Therapy Development Institute, USA

  • UK-Mahmood-Anwar

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  • Eddy LeFrançois, Diagnosed 1992 - ALS Canada

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  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Richard Clark, MND New Zealand, Diagnosed 2011, New Zealand

    Richard Clark, MND New Zealand, Diagnosed 2011, New Zealand

  • Dorette Lüdi, Diagnosed 2014 - ALS Schweiz, Switzerland

    Dorette Lüdi, Diagnosed 2014 – ALS Schweiz, Switzerland

  • Brian Lovell, Diagnosed 2011 - MND Australia

    Brian Lovell, Diagnosed 2011 – MND Australia

  • Roxana Canova, Diagnosed 2012 - Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 – Asociación ELA Argentina

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

  • Fabio Carvalho

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  • Fabrice Kamp, Germany

    Fabrice Kamp, Germany

  • Margreth Burger-Saile, Diagnosed 2011 - ALS Schweiz, Switzerland

    Margreth Burger-Saile, Diagnosed 2011 – ALS Schweiz, Switzerland

  • Susan Anderson, Diagnosed 2014 - Hope Loves Company, USA

    Susan Anderson, Diagnosed 2014 – Hope Loves Company, USA

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