GSK has announced that a Phase 3 trial comparing an HFA-152a formulation of Ventolin salbutamol (albuterol) MDI to the currently marketed HFA-134a formulation demonstrated therapeutic equivalence. The company also said that safety of the LGWP propellant formulation was comparable.
According to the announcement, GSK now expects to have completed regulatory submissions and to have received approval in time for a 2026 launch of the reformulated inhaler. In 2021, GSK announced a project to reformulate Ventolin with an LGWP propellant. In November 2023, the company said that it planned to initiate Phase 3 trials of an HFA-152a formulation in 2024 with regulatory submission planned for 2025.
GSK Senior VP, Global Head, Respiratory, Immunology & Inflammation R&D, Kaivan Khavandi commented, “Healthy air is essential for healthy lungs, and our next-generation salbutamol has the potential to reduce greenhouse gas emissions by 92% per inhaler. Almost six decades after its first development, this medicine remains highly valued by patients and healthcare professionals and is a key component of our respiratory portfolio. Today, we are one step closer to a reliever MDI that we believe will continue to help patients for many decades to come.”
Read the GSK press release
