At the moment, the therapy is being delivered by nebuliser. The plan is to switch to a dry powder device but development of this is proving complex. What is the most appropriate next step?
Select one option from the answers below.
A. Incorrect. This is a systemic route of administration. The safety profile of your drug could be very different when it is administered systemically rather than topically to the lung.
B. Incorrect. This is a systemic route of administration. The safety profile of your drug could be very different when it is administered systemically rather than topically to the lung. It is also likely to be an impractical route of administration for regular asthma therapy.
C. Incorrect. At the moment you have limited evidence for the efficacy of your drug. If you stick with a nebuliser then patients will require this device to take the drug. This will exclude the vast majority of asthma patients and this approach may not be viable.
D. Incorrect. It is tempting to continue development and hope to switch later on but without a clear idea of whether the delivery device is viable you could be committing to very substantial spends without any guarantee of success.
E. Correct. It seems unfortunate to suspend development until you know about the device but a drug is only a medicine if it can be given in an appropriate way that will be practical for patients. You need to have confidence in the device before continuing to spend on the development of this molecule.