Inhalation Sciences provides latest status update on ongoing FDA BAA dissolution research project
(Stockholm, 16 October 2024) Inhalation Sciences Sweden AB (ISAB) today releases the latest update on progress in its FDA BAA (Broad Agency Agreement) dissolution collaborative research project evaluating the discriminative power of ISAB’s DissolvIt® in comparing drug formulations aimed for administration via inhalation. The project - contract number 75F40122C00197 - was communicated by ISAB on September 15th, 2022, with updates throughout 2023.
ISAB today announces that the deadline for the formal completion of its FDA BAA project has been extended by six months, with an updated completion date of March 29th 2025, at latest. The project has been extended due to the extensive volume of data to be presented in the report and the extension was agreed upon at the suggestion of the FDA.
All the laboratory work and data for the project has been finalized and submitted to the FDA, including the study’s key PBPK (physiologically based pharmacokinetic) models.
The remaining part of the project is the finalization of the project report, in accordance with FDA regulations.
ISAB plans to be able to release top-line data from the report before the end of 2024, as previously communicated.
CEO Manoush Masarrat: “Our collaboration with FDA has been very positive. This is a project that clearly represents a major opportunity for ISAB to evaluate the methodology and data generated by our DissolvIt® module and where we today lack a recommended standard method of high enough quality. We look forward to finalizing the report in the near-term future and communicating the results ‘of the project”.
