AptarGroup, Inc. (NYSE: ATR) has announced the commencement of a clinical validation study for its proprietary SmartTrack™ platform, developed by its drug services company Nanopharm. The study aims to establish SmartTrack™ as a credible alternative to comparative clinical endpoint (CCEP) studies for generic inhaled drug product approvals.
The validation study, scheduled to begin in Q2 2025, could significantly transform the regulatory pathway for generic inhaled medications by demonstrating that computational modeling can accurately predict clinical outcomes. If successful, this approach would remove a major barrier in the approval process for generic inhalers, potentially expanding patient access to these medications.
"This clinical study marks a significant milestone in the evolution of Aptar's offerings," said Gael Touya, President of Aptar Pharma. "Providing clinically validated data to our pharmaceutical partners and regulatory bodies will be crucial in demonstrating the platform's viability, which could lead to accelerated approvals and broader access to generic inhaled medicines for more patients."
Study Design and Methodology
The clinical validation study has been meticulously designed based on detailed feedback from regulatory agencies. It will involve radio-labelling three different commercially available pressurized metered-dose inhaler (pMDI) drug products and imaging regional lung deposition patterns in human subjects.
These empirical results will then be compared with regional deposition predictions generated through computational fluid dynamic (CFD) simulations. The computational work will be conducted through collaborations with Fluidda, Medimprove, and i2c Pharmaceutical Services, leveraging their expertise in respiratory modeling.
Additionally, the study will collect pharmacokinetic (PK) data from subjects to validate predictions from Nanopharm's Simhalation™ platform, which employs physiologically based pharmacokinetic (PBPK) modeling to simulate drug absorption and distribution.
Regulatory Implications and Industry Impact
Upon completion, the study data will be submitted to the U.S. Food and Drug Administration (FDA) as one of the first Model Master Files (MMF). This innovative regulatory approach would allow multiple pharmaceutical companies to reference this data when partnering with Aptar, similar to the established Drug Master File (DMF) pathway used for manufacturing information.
If validated, SmartTrack™ would offer pharmaceutical companies a pathway to obtain a biowaiver for comparative clinical endpoint studies, which are typically time-consuming and expensive components of generic drug applications. This could significantly reduce development costs and timelines for generic inhaled products.
The platform's potential extends beyond generic Abbreviated New Drug Application (ANDA) approvals. It could also accelerate and de-risk other development programs, including:
- Reformulation of pMDIs with new lower global warming potential (GWP) propellants
- Development of novel drug product combinations
- Conversion of medications from other dosage forms to inhalation delivery
- New Chemical Entity (NCE) development for pMDI delivery
Timeline and Industry Access
The validation study is expected to conclude by the end of 2025. Aptar has indicated that pharmaceutical companies interested in leveraging this technology for their development programs can contact Nanopharm to explore potential collaborations.
This initiative comes at a critical time for the respiratory medicine field, as demand for cost-effective inhaled therapies continues to grow globally, while regulatory requirements for demonstrating bioequivalence remain challenging for generic manufacturers.
By establishing a scientifically robust alternative to clinical endpoint studies, Aptar's SmartTrack™ platform could potentially address a significant bottleneck in the development of generic inhaled medications, ultimately benefiting patients through increased access to affordable treatment options.
About Nanopharm and Aptar
Nanopharm, Aptar's drug services company, specializes in analytical, modeling, and pharmaceutical development services with a focus on orally inhaled and nasal drug products. The company employs unique analytical technologies and formulation development tools to support pharmaceutical companies in understanding how drug product properties influence functionality.
AptarGroup is a global leader in drug and consumer product dosing, dispensing, and protection technologies, serving pharmaceutical, beauty, food, beverage, personal care, and home care markets worldwide.
