~ Buy the NUEDEXTA (dextromethorphan hydrobromide; quinidine sulfate) Drug Profile, 2024 PDF Report in the Report Store ~

CLINICAL TRIALS PROFILE FOR NUEDEXTA

All Clinical Trials for nuedexta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01630811 ↗	Nuedexta for the Treatment of Adults With Autism	Completed	Sutter Health	Phase 2	2012-01-24	Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8 weeks over subjects given placebo. Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS).
NCT01799941 ↗	Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)	Completed	OptumInsight Life Sciences	Phase 4	2013-02-01	The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.
NCT01799941 ↗	Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)	Completed	Avanir Pharmaceuticals	Phase 4	2013-02-01	The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.
NCT01806857 ↗	Clinical Trial Nuedexta in Subjects With ALS	Completed	ALS Association	Phase 2	2013-04-01	The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).
NCT01806857 ↗	Clinical Trial Nuedexta in Subjects With ALS	Completed	State University of New York - Upstate Medical University	Phase 2	2013-04-01	The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).
NCT01806857 ↗	Clinical Trial Nuedexta in Subjects With ALS	Completed	Center for Neurologic Study, La Jolla, California,	Phase 2	2013-04-01	The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).
NCT01832350 ↗	Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease	Terminated	Avanir Pharmaceuticals	Phase 4	2012-08-28	The primary objective of this study is to test the hypothesis that Nuedexta (20/10) administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients with Alzheimer's Disease (AD). The primary objective will be evaluated using a study endpoint at 1, 13, 26 weeks after initiation of treatment. The secondary objective of this study is to evaluate the benefit of treatment with Nuedexta (20/10) on cognition and functionality as demonstrated in the Rey Auditory Verbal Learning Test (RAVLT), Trail making A and B, Wechsler Memory Scale (WMS) logical memory and delayed recall, Controlled Oral Word Association (COWA), Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI), Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).

Clinical Trial Conditions for nuedexta

Condition Name

Condition Name for nuedexta
Intervention	Trials
Major Depressive Disorder	3
Pseudobulbar Affect (PBA)	2
Pseudobulbar Affect (Involuntary Laughing and/or Crying)	1
Alzheimer's Disease	1

Condition MeSH

Condition MeSH for nuedexta
Intervention	Trials
Depressive Disorder, Major	3
Depressive Disorder	3
Depression	3
Motor Neuron Disease	2

Clinical Trial Locations for nuedexta

Trials by Country

Trials by Country for nuedexta
Location	Trials
United States	19

Trials by US State

Trials by US State for nuedexta
Location	Trials
Florida	3
New York	2
Ohio	2
California	2
Texas	1

Clinical Trial Progress for nuedexta

Clinical Trial Phase

Clinical Trial Phase for nuedexta
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for nuedexta
Clinical Trial Phase	Trials
Completed	6
Terminated	2
Not yet recruiting	1

Clinical Trial Sponsors for nuedexta

Sponsor Name

Sponsor Name for nuedexta
Sponsor	Trials
Avanir Pharmaceuticals	4
ALS Association	2
University of Florida	1

Sponsor Type

Sponsor Type for nuedexta
Sponsor	Trials
Other	15
Industry	4

Nuedexta Market Analysis and Financial Projection

NUEDEXTA: Clinical Trials, Market Analysis, and Projections

Introduction to NUEDEXTA

NUEDEXTA, a combination drug comprising dextromethorphan and quinidine, is the only FDA-approved treatment for pseudobulbar affect (PBA), a condition characterized by sudden, uncontrollable episodes of crying or laughing. Here, we delve into the clinical trials, market analysis, and future projections for this innovative medication.

Clinical Trials and Efficacy

Pivotal Clinical Trials

NUEDEXTA has undergone several rigorous clinical trials to establish its safety and efficacy.

• Study 1: The first pivotal trial involved 140 patients with ALS/MND and PBA. Participants were randomized into three groups: one receiving NUEDEXTA, one receiving 30 mg of dextromethorphan, and one receiving 30 mg of quinidine. The results showed that patients taking NUEDEXTA experienced a significant reduction in PBA episodes, scoring 3.5 points lower on the symptom scale compared to the other groups. This study was published in Neurology in 2004[1].

• Study 2: A second trial involved 150 patients with multiple sclerosis, where participants received either NUEDEXTA or a placebo. NUEDEXTA reduced PBA symptom scores by 7.7 points on average, compared to a 3.3-point reduction in the placebo group. These results were published in Annals of Neurology in 2006[1].

• Study 3: A third trial compared two different compositions of NUEDEXTA in 283 patients with ALS/MND and PBA. Both compositions of NUEDEXTA significantly reduced PBA episodes and symptom scores, with the higher dose leading to improved social functioning and mental health. This study was also published in Annals of Neurology[1].

Ongoing and Future Trials

• Speech and Swallowing Trials: There are ongoing clinical trials investigating the potential of NUEDEXTA to improve speech and swallowing in patients with ALS/MND. A recent trial showed promising results, though more research is needed to fully understand its effects[1].

• Pediatric Trials: Under the Pediatric Research Equity Act (PREA), studies are being conducted to assess the safety and efficacy of NUEDEXTA in pediatric patients (ages 2-16) with PBA. These trials aim to fill the gap in pediatric treatment options[3].

Market Analysis and Projections

Global ALS Treatment Market

The global amyotrophic lateral sclerosis (ALS) treatment market, which includes treatments for PBA, is experiencing significant growth.

• Market Size and Growth: As of 2024, the global ALS treatment market was valued at approximately USD 0.72 billion and is projected to reach USD 0.97 billion by 2030, growing at a CAGR of 5.1% during the forecast period (2025-2030)[2].

• Key Players: Major players in this market include Mitsubishi Tanabe Pharma Corporation, Biogen, BrainStorm Cell Limited, Amylyx Pharmaceuticals, Inc., and others. These companies are driving innovation and investment in ALS treatments[2].

NUEDEXTA Market Exclusivity

• Patent Protection: Avanir Pharmaceuticals, the manufacturer of NUEDEXTA, has maintained patent protection for the drug until 2026, following a successful appeal in the U.S. Court of Appeals for the Federal Circuit. This ensures market exclusivity for NUEDEXTA in the treatment of PBA[5].

Safety and Side Effects

Common Adverse Effects

Clinical trials have identified the most common adverse effects of NUEDEXTA as diarrhea and dizziness. In some studies, headache has also been reported as a common side effect[4].

Dose and Administration

NUEDEXTA is administered in a specific regimen: one capsule containing 20 mg of dextromethorphan and 10 mg of quinidine is taken once daily for the first seven days, followed by twice daily thereafter[1].

Mechanism of Action

Although the exact mechanism by which NUEDEXTA works is not fully understood, it is known that dextromethorphan acts on sigma-1 and NMDA receptors in the brain. Quinidine, a metabolic inhibitor, helps maintain therapeutic concentrations of dextromethorphan[5].

Key Takeaways

• Clinical Efficacy: NUEDEXTA has demonstrated significant efficacy in reducing PBA episodes in multiple clinical trials involving patients with ALS/MND and multiple sclerosis.
• Market Growth: The global ALS treatment market is projected to grow at a CAGR of 5.1% from 2025 to 2030, driven by increasing prevalence and investment.
• Patent Protection: NUEDEXTA maintains market exclusivity until 2026, ensuring continued dominance in the PBA treatment market.
• Safety Profile: Common side effects include diarrhea, dizziness, and headache, with a generally favorable safety profile.

FAQs

What is NUEDEXTA used for?

NUEDEXTA is used for the treatment of pseudobulbar affect (PBA), a condition characterized by sudden, uncontrollable episodes of crying or laughing.

What are the common side effects of NUEDEXTA?

The most common adverse effects of NUEDEXTA are diarrhea, dizziness, and headache.

Is NUEDEXTA approved for use in children?

Currently, NUEDEXTA is not approved for pediatric use, but clinical trials are ongoing to assess its safety and efficacy in children aged 2-16 with PBA.

How is NUEDEXTA administered?

NUEDEXTA is administered once daily for the first seven days and then twice daily thereafter, with each capsule containing 20 mg of dextromethorphan and 10 mg of quinidine.

What is the projected market size for ALS treatments by 2030?

The global ALS treatment market is projected to reach approximately USD 0.97 billion by 2030.

Who are the major players in the ALS treatment market?

Major players include Mitsubishi Tanabe Pharma Corporation, Biogen, BrainStorm Cell Limited, Amylyx Pharmaceuticals, Inc., and others.

Sources

1. International Alliance of ALS/MND Associations - Nuedexta.
2. MarkNtel Advisors - Amyotrophic Lateral Sclerosis Treatment Market.
3. FDA - Nuedexta NDA 21879 PMR/PMC Development Template.
4. NUEDEXTA HCP Site - Safety & Efficacy.
5. Biospace - AVANIR Pharmaceuticals Prevails In NUEDEXTA Patent Appeal.