Q: What do you see as the implications of the FDA’s endorsement of MDRS in the mometasone furoate nasal spray ANDA approval for future generic nasal spray development?
A: The most obvious implication of this ANDA approval is that it reveals the FDA’s openness to accepting in vitro data in place of clinical endpoint study data to support locally-acting generic nasal spray submissions. Furthermore, it shows that the FDA is receptive to the submission of data generated using relatively new analytical techniques.
This suggests that there is value in identifying those analytical techniques that most easily and effectively enable or aid the demonstration of BE between an RLD and test product. Streamlining and improving the relevance and efficiency of in vitro testing has the potential to accelerate time to market as well as significantly cutting costs. For example, we are conducting some research in conjunction with Nanopharm to demonstrate that rheological testing quantifying the response of a formulation to the shear imposed by a nasal spray device can support the demonstration of formulation/device equivalence.
In terms of the broader application of MDRS in regulatory submissions, the component-specific measurement capabilities it offers are particularly relevant to combination dry powder inhaler (DPI) products, especially those that contain more than one active. For these products, MDRS enables assessment of the degree of dispersion of each API and an understanding of the associated dispersion mechanisms (which may correlate with co-deposition). This is valuable information for generic developers targeting such products but equally, in the long run, may prove pivotal to innovators looking to reach new levels of drug dispersion performance, a long-standing goal for the industry.
