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GSK announces upcoming Phase 3 trials of HFA 152a version of Ventolin salbutamol (albuterol) MDI

GSK has announced that data generated from recently early stage trials support advancing a reformulated version of its Ventolin salbutamol (albuterol) MDI using HFA 152a as the propellant into Phase 3 trials. The company said that it expects to initiate those studies in the first half of 2024 with plans to file regulatory submissions for the reformulated product in 2025, assuming that the Phase 3 trials are successful. The Ventolin HFA 152a inhalers will be manufactured at GSK’s site in Evreux, France, which is being updated to handle the new propellant, the company said.

In September 2021, GSK announced that it was evaluating a lower carbon propellant for use in its metered dose inhalers. According to GSK, Ventolin is currently responsible for 49% of the company’s carbon footprint, and switching to a lower global warming potential (LGWP) propellant is “a key milestone in the company’s pathway to net zero.”

GSK Chief Executive Officer Emma Walmsley commented, “As countries work to decarbonize their health systems, companies have an important role to play, and addressing the carbon emissions from inhalers is a key part of this. Harnessing our deep respiratory expertise, we have developed an innovative low carbon inhaler, and I am delighted that we are now progressing this program into Phase 3 trials. If successful, this could lead to regulatory submissions in 2025, supporting the health of asthma and COPD patients and making a significant positive impact on our transition to a more environmentally sustainable future.”

Read the GSK press release.

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published on November 21, 2023

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