Tuesday, February 18, 2020

Tuesday, February 18, 2020

KOURA: 'Green' Medical Propellant Receives FDA Approval to Proceed to Clinical Trials


Koura issued the following announcement on Feb. 4.

Koura (previously known as Mexichem Fluor), a pioneer in the development of next generation propellants, today announced FDA approval to proceed to clinical trials with Zephex® 152a. This new medical propellant has been under development for several years for use in metered-dose inhalers (MDIs) for treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD). Zephex® 152a reduces the carbon footprint of an MDI, helping to safeguard an invaluable therapeutic option for patients.

"Koura has a proud history of innovation, and these forthcoming clinical trials in the United States mark an important milestone in delivering a solution that balances product efficacy and environmental stewardship," said Sameer Bharadwaj, president of Koura. "Supplying this critical technology to the many millions of patients who suffer from asthma moves the needle on sustainable care and conscientious development throughout our industry."

Global Warming Potential (GWP) is a measure of the atmospheric warming potential of a propellant upon release into the atmosphere. Pressurized metered-dose-inhalers using Zephex® 152a will bring about a greater than 90 percent reduction in GWP compared to some current MDI propellants2. As a result, the use of Zephex® 152a will result in an environmental impact comparable to other 'green' technologies, including dry powder inhalers, when accounting for manufacturing, use and disposal. Utilization of the 152a molecule as a lower GWP inhaler propellant addresses concerns of both patients and pharmaceutical companies. 1

Clinical trials with Zephex® 152a will take place in the United States and are expected to begin in February 2020 and conclude within Q1. Recognizing the value of Zephex® 152a, the Italy-based Chiesi Farmaceutici announced its intentions to develop Zephex® 152a-based inhalation products for launch in 2025. Koura has also committed to a multimillion-pound investment into a new laboratory facility in the UK; the first in the world to offer dedicated pharmaceutical-grade laboratories specializing in the commercial development of 152a-based inhaled medicines.

Original source can be found here.

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