A spray-on patch therapy exists that can allow dosing of patients through an invisible and unfelt spray-on patch. Cost of goods are low – a simple metered dose aerosol with simple excipients. Transdermal patches exist for ADHD and Alzheimers which allow for 505b2 route through regulatory approval in the US, and similar phase III waiver in Europe. Estimated costs from Proof of Concept through to NDA submission are around USD3M. Further QoL/Adherence study work would support higher pricing of the launched product.
Global IP is strong, and production facilities can be arranged. Anticipated time through to commercialisation is 3 years.
This is a 505b2/phase III waiver product - Phase III is probably most descriptive as only one more BE study is required.
Proof of Concept exists for ADHD. This now requires scale up for clinical supplies, a bioequivalence study then Dossier preparation.