Related Experiment Video
Updated: Jul 14, 2025
Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System
Published on: April 6, 2017
Food and Drug Administration Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development
Caroline J Jjingo1, Shukal Bala1, Ursula Waack1
1Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Abstract:
Allergic bronchopulmonary aspergillosis and invasive fungal diseases represent distinct infectious entities that cause significant morbidity and mortality. Currently, administered inhaled antifungal therapies are unapproved, have suboptimal efficacy, and are associated with considerable adverse reactions. The emergence of resistant pathogens is also a growing concern. Inhaled antifungal development programs are challenged by inadequate nonclinical infection models, highly heterogenous patient populations, low prevalence rates of fungal diseases, difficulties defining clinical trial enrollment criteria, and lack of robust clinical trial endpoints. On 25 September 2020, the US Food and Drug Administration (FDA) convened a workshop with experts in pulmonary medicine and infectious diseases from academia, industry, and other governmental agencies. Key discussion topics included regulatory incentives to facilitate development of inhaled antifungal drugs and combination inhalational devices, limitations of existing nonclinical models and clinical trial designs, patient perspectives, and industry insights.
Insights
Developing inhaled antifungal therapies for serious fungal lung infections like allergic bronchopulmonary aspergillosis is challenging. A US Food and Drug Administration (FDA) workshop identified key hurdles and discussed strategies to improve drug development and clinical trials.
Area of Science:
- Pulmonary Medicine
- Infectious Diseases
- Drug Development
Background:
- Allergic bronchopulmonary aspergillosis and invasive fungal diseases cause significant illness and death.
- Current inhaled antifungal treatments lack approval, have limited effectiveness, and cause adverse effects.
- Antifungal resistance is an increasing concern in treating these pulmonary fungal infections.
Purpose of the Study:
- To address challenges in developing inhaled antifungal drugs for fungal lung diseases.
- To discuss regulatory incentives and improve nonclinical models and clinical trial designs.
- To gather insights from experts on patient perspectives and industry challenges.
Main Methods:
- Convened a US Food and Drug Administration (FDA) workshop on September 25, 2020.
- Brought together experts in pulmonary medicine and infectious diseases from academia, industry, and government.
- Focused discussions on regulatory, preclinical, and clinical trial aspects of inhaled antifungal development.
Main Results:
- Identified significant challenges in nonclinical models and clinical trial design for inhaled antifungals.
- Highlighted the need for regulatory incentives to foster development of new inhaled antifungal drugs and devices.
- Acknowledged the heterogeneity of patient populations and the low prevalence of these fungal diseases.
Conclusions:
- There is a critical need for improved inhaled antifungal therapies for pulmonary fungal infections.
- Addressing limitations in research models and clinical trial methodologies is essential for progress.
- Collaborative efforts and regulatory support are crucial to overcome barriers in developing effective inhaled antifungal treatments.
More Related Videos
04:59Author Spotlight: Developing a Disposable Dosator for Preclinical Testing of Dry Powder Inhalers in Small Animal Models
Published on: August 18, 2023
10:26P. aeruginosa Infected 3D Co-Culture of Bronchial Epithelial Cells and Macrophages at Air-Liquid Interface for Preclinical Evaluation of Anti-Infectives
Published on: June 15, 2020
Related Concept Videos
01:25Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids
ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...
01:23Inhaled Medications
01:22Drug Delivery: Miscellaneous Routes
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
01:20Asthma: Pathogenesis and Management
Asthma is classified as allergic and non-allergic. Allergens such as dust mites, pollen, and pet dander trigger allergic asthma, while factors like cold air, intense emotions, or exercise can induce non-allergic asthma.
01:17Drugs Used in Lower Respiratory Disorders: Overview
Bronchodilators, the first step of respiration enhancement, come in various forms, each with its own mechanism...
01:26COPD: Management Using Bronchodilators and Corticosteroids