CLINICAL TRIALS PROFILE FOR BROMPHENIRAMINE MALEATE

505(b)(2) Clinical Trials for BROMPHENIRAMINE MALEATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00894634 ↗	Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2009-03-21	The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs.

All Clinical Trials for BROMPHENIRAMINE MALEATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01393548 ↗	Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis	Completed	Ache Laboratorios Farmaceuticos S.A.	Phase 3	2014-08-01	This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
NCT01393561 ↗	Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis	Completed	Ache Laboratorios Farmaceuticos S.A.	Phase 3	2014-07-01	This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
NCT01177852 ↗	Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis	Withdrawn	Ache Laboratorios Farmaceuticos S.A.	Phase 3	2011-10-01	Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
NCT00894634 ↗	Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2009-03-21	The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs.

Clinical Trial Conditions for BROMPHENIRAMINE MALEATE

Condition Name

Condition Name for BROMPHENIRAMINE MALEATE
Intervention	Trials
Rhinitis	3
Nasal Congestion and Inflammations	2
Allergic Reactions	1
Cough	1

Condition MeSH

Condition MeSH for BROMPHENIRAMINE MALEATE
Intervention	Trials
Rhinitis	3
Inflammation	3
Cough	1
Common Cold	1

Clinical Trial Locations for BROMPHENIRAMINE MALEATE

Trials by Country

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−

Trials by Country for BROMPHENIRAMINE MALEATE
Location	Trials
Brazil	1

Clinical Trial Progress for BROMPHENIRAMINE MALEATE

Clinical Trial Phase

Clinical Trial Phase for BROMPHENIRAMINE MALEATE
Clinical Trial Phase	Trials
Phase 3	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for BROMPHENIRAMINE MALEATE
Clinical Trial Phase	Trials
Completed	3
Withdrawn	1

Clinical Trial Sponsors for BROMPHENIRAMINE MALEATE

Sponsor Name

Sponsor Name for BROMPHENIRAMINE MALEATE
Sponsor	Trials
Ache Laboratorios Farmaceuticos S.A.	3
Wyeth is now a wholly owned subsidiary of Pfizer	1

Sponsor Type

Sponsor Type for BROMPHENIRAMINE MALEATE
Sponsor	Trials
Industry	4

Brompheniramine Maleate: Clinical Trials, Market Analysis, and Projections

Introduction to Brompheniramine Maleate

Brompheniramine maleate is an antihistamine medication widely used in the treatment of various allergic conditions, including allergic rhinitis, hay fever, and conjunctivitis. It works by binding to the histamine H1 receptor, thereby blocking the action of endogenous histamine and providing relief from symptoms such as sneezing, itchy nose or throat, and runny nose.

Clinical Trials and Efficacy

Comparative Studies

A notable clinical trial compared the efficacy and tolerance of brompheniramine maleate with clemastine fumarate in patients suffering from chronic urticaria. This partially-blind, three-way crossover study involved 24 patients who received 4-week courses of treatment with either 12 mg brompheniramine, 1 mg clemastine, or a placebo. The results indicated that both antihistamines were significantly effective compared to the placebo, with brompheniramine showing better long-term control than clemastine. However, side effects such as drowsiness were reported by 4 patients taking brompheniramine and 3 patients taking clemastine[1].

Dosage and Administration

Brompheniramine maleate is often combined with other medications to treat cough and nasal congestion. For example, the formulation Bromfed-DM includes brompheniramine maleate 2mg, pseudoephedrine HCl 30mg, and dextromethorphan HBr 10mg per 5mL. The dosage for adults is typically 10mL every 4 hours, with specific guidelines for children based on age[4].

Market Analysis

Global Market Size and Growth

The global brompheniramine maleate market is experiencing steady growth driven by several key factors. As of 2023, the market size was valued at USD 10 billion and is projected to reach USD 14 billion by 2031, growing at a CAGR of 4% from 2024 to 2031[3].

Regional Trends

The market is analyzed across various regions, with North America currently holding the majority share due to advanced healthcare infrastructure and easy access to over-the-counter (OTC) medications for allergic conditions. However, the Asia-Pacific region is expected to witness the highest growth rate due to the rise in prevalence of allergic conditions, increased consumer awareness, and the presence of key market players[2][3].

Key Market Players

The market is dominated by several major pharmaceutical companies, including Capellon Pharmaceuticals, Sun Pharmaceutical Industries Limited, Bayer AG, Viatris Inc., Johnson & Johnson, GlaxoSmithKline plc, and Merck & Co., Inc. These companies play a significant role in the manufacturing and distribution of brompheniramine maleate products[2].

Market Drivers

The growth of the brompheniramine maleate market is driven by several factors:

• Increasing Prevalence of Allergies: Environmental issues like pollution and climate change are contributing to a global increase in allergy cases, driving up demand for antihistamines.
• Rising Consumer Awareness: Growing awareness among consumers about the symptoms and management of allergies fuels the market growth.
• Availability of OTC Formulations: The wide availability of brompheniramine maleate in OTC forms supports market expansion.
• Expanding Healthcare Infrastructure: Rising disposable incomes and expanding healthcare infrastructure in emerging nations are also contributing to the market's growth[2][3].

Market Projections

Forecast Period

The market forecast for brompheniramine maleate extends from 2023 to 2031, with a projected CAGR of 4%. This growth is expected to be sustained by the increasing prevalence of allergic disorders, technological advancements, and the rising geriatric population[3].

Market Size by 2031

By 2031, the global brompheniramine maleate market is expected to reach USD 14 billion, up from USD 10 billion in 2023. This significant growth underscores the ongoing demand for effective antihistamine medications[3].

Regional Growth

While North America is expected to remain a dominant market, the Asia-Pacific region is anticipated to experience the highest growth rate. Emerging economies such as India, China, and South Korea will offer lucrative opportunities due to the surge in unhealthy and sedentary lifestyles, rise in geriatric population, and increase in prevalence of allergic conditions[2].

Challenges and Restraints

Despite the positive growth projections, the market faces several challenges:

• Side Effects: Potential side effects such as drowsiness, dry mouth, blurred vision, and urinary retention can hamper market growth.
• Alternative Medications: The availability of alternative medications to treat allergies can also restrain the market[2].

Key Takeaways

• Efficacy and Tolerance: Brompheniramine maleate has shown significant efficacy in clinical trials, particularly in long-term control of allergic symptoms.
• Market Growth: The global market is projected to grow at a CAGR of 4% from 2024 to 2031, driven by increasing allergy prevalence and consumer awareness.
• Regional Trends: North America currently dominates the market, but the Asia-Pacific region is expected to witness the highest growth rate.
• Challenges: Side effects and the availability of alternative medications are key restraints to market growth.

FAQs

What is brompheniramine maleate used for?

Brompheniramine maleate is used in the treatment of various allergic conditions, including allergic rhinitis, hay fever, and conjunctivitis. It also helps relieve symptoms such as sneezing, itchy nose or throat, and runny nose caused by allergies and the common cold.

What are the common side effects of brompheniramine maleate?

Common side effects include drowsiness, dry mouth, blurred vision, and urinary retention. In some cases, it can also cause anticholinergic effects and thickening of bronchial secretions.

How is brompheniramine maleate administered?

Brompheniramine maleate can be administered in various formulations, including liquid and tablet forms. For example, the formulation Bromfed-DM includes brompheniramine maleate 2mg, pseudoephedrine HCl 30mg, and dextromethorphan HBr 10mg per 5mL, with a typical adult dosage of 10mL every 4 hours.

What are the key drivers of the brompheniramine maleate market?

The market is driven by the increasing prevalence of allergic disorders, rising consumer awareness about allergy management, the availability of OTC formulations, and the expanding healthcare infrastructure in emerging nations.

Which regions are expected to see significant growth in the brompheniramine maleate market?

North America is currently the dominant market, but the Asia-Pacific region is expected to witness the highest growth rate due to the rise in prevalence of allergic conditions and increasing consumer awareness.

What are the potential restraints to the growth of the brompheniramine maleate market?

The availability of alternative medications to treat allergies and the potential side effects of brompheniramine maleate, such as drowsiness and dry mouth, are expected to hamper market growth.

Sources

1. A placebo-controlled comparative study of sustained-release brompheniramine maleate against clemastine fumarate in the treatment of chronic urticaria. PubMed.
2. Chlorpheniramine Maleate Market Statistics and Forecast - 2032. Allied Market Research.
3. Brompheniramine Market Size and Projections. Market Research Intellect.
4. BROMFED-DM Dosage & Rx Info | Uses, Side Effects. EMPR.
5. Brompheniramine Maleate Market Size, Share ... - Prof Research. Prof Research.