The FDA has granted qualified infectious disease product (QIDP) designation to two Bayer investigational agents, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).
Amikacin Inhale (BAY 41-6551), is the development name for an integrated drug-device combination, developed by Bayer HealthCare in collaboration with Nektar Therapeutics as an adjunctive therapy for intubated and mechanically ventilated patients with Gram-negative pneumonias.
Ciprofloxacin dry powder for inhalation is the development name of a drug-device combination currently being investigated in non-cystic fibrosis bronchiectasis (NCFB) by Bayer HealthCare.
I currently have a large population of ventialtor patients with a variety of MDRO organisms that we are currently treating with only aminoglycosides inhaled via the mesh nebulizer route. We use the Aerogen Mesh nebuliser to administer this deliver of ABX and have been successful at PNA erradication. I would be very interested in the pathways that this ABX delivey is planned for and the mechanisms that you plan for dispensing to ventialtor patients. If yo seek a trial site you could find none better than ours due to our steamlined IRB committee. Gerard Marshall BS RRT 702-306-4775