OINDP development specialist Nanopharm, which was acquired by Aptar Pharma in 2019, and functional respiratory imaging (FRI) company Fluidda are teaming up to help sponsors of ANDAs for inhaled drugs for asthma and COPD avoid the need for clinical end-point studies by pursuing the alternative bioequivalence pathway. Sponsors of 505(b)(2) NDAs for inhaled drugs and companies reformulating MDIs to use lower-GWP propellants may also benefit from the combination of Nanopharm’s SmartTrack development platform and Fluidda’s FRI technology to better understand their products before going into the clinic, the companies said.
Nanopharm and Fluidda have already been working together and separately for a number of years on the use of only in vitro and in silico methods only to demonstrate the bioequivalence of OINDPs using techniques such as Nanopharm’s physiologically-based models of lung pharmacokinetics and Fluidda’s ability to predict regional drug deposition using FRI and CFD. According to the announcement, the FDA is nearing likely approval of the first inhaled drug using the alternative bioequivalence path, an event that it says, “will further validate Nanopharm’s SmartTrack as the go-to solution for alternative bioequivalence studies and should accelerate demand for the companies’ collective services.”
Nanopharm VP, Science & Technology, Jag Shur said, “We are pleased to solidify our relationship with Fluidda and its world-leading FRI technology. A company would have to spend several years to achieve the current combined expertise and experience of Nanopharm and Fluidda. The collaboration between Nanopharm and Fluidda has the potential to revolutionize this arduous regulatory pathway.”
Aptar Pharma VP, Analytical, Regulatory and Scientific Affairs, Guillaume Brouet, added, “Aptar Pharma is delighted to collaborate with Fluidda on this important development, which reinforces our mission to help customers derisk and accelerate their drug product development programs.”
Fluidda CEO Jan de Backer commented, “Fluidda has already demonstrated the applicability of its FRI platform to provide more objective data for evaluating and administering inhaled drug products accurately. Nanopharm’s unique SmartTrack platform provides us with clinically-relevant input data without having to actually go into the clinic, which really adds another level of confidence to the models, and provides an integrated perspective.”
Read the Aptar Pharma and Fluidda press release.
