Clinical trials go-ahead for ‘green’ medical device propellant

Sameer Bharadwaj

A Cheshire medical group has been given approval by US authorities to proceed with trials for its ‘green’ technology used in devices such as asthma inhalers.

Koura, previously known as Mexichem Fluor, has been developing its Zephex 152a technology for several years.

It enables more than than a 90% reduction in inhaler carbon footprints compared with current metered-dose inhalers (MDIs).

Zephex has now been given FDA approval to proceed to clinical trials.

“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.

Pressurised metered-dose-inhalers using Zephex will bring about a greater than 90% reduction in GWP compared with some current MDI propellants.

As a result, the use of Zephex will result in an environmental impact comparable with other ‘green’ technologies, including dry powder inhalers, when accounting for manufacturing, use and disposal. Utilisation of the 152a molecule as a lower GWP inhaler propellant addresses concerns of both patients and pharmaceutical companies.

Clinical trials with Zephex 152a will take place in the US and are expected to begin imminently and conclude within the first quarter of 2020.

Recognising the value of Zephex, the Italy-based Chiesi Farmaceutici announced its intentions to develop Zephex-based inhalation products for launch in 2025.

Koura has also committed to a multimillion-pound investment into a new laboratory facility, the first in the world to offer dedicated pharmaceutical-grade laboratories specialising in the commercial development of 152a-based inhaled medicines.

The new facility will be based at its medical division headquarters at Thornton Science Park, Chester.