AeroLEF™ is a proprietary formulation of free and liposome encapsulated fentanyl, a potent analgesic. It is intended for administration by pulmonary inhalation for the treatment of acute pain, including breakthrough cancer pain. AeroLEF™ is a product designed to meet the unique dosing needs of the individual, providing real-time patient directed pain relief. Using DELEX's proprietary Rapid Onset and Sustained Effect Delivery System (ROSE-DS) platform technology, AeroLEF™ provides rapid onset and extended pain relief to patients (Fig. IV-35). The development of AeroLEF™ as a pulmonary dosage form takes advantage of:
1. the lung's large absorptive surface and thin barrier to absorption, which permits rapid transport of the free fentanyl fraction into the blood stream.
2. the capacity of liposomes to function as reservoirs for the regulated release of encapsulated fentanyl over a period of time to extend the duration of action.
Currently, fentanyl is available in intravenous, transmucosal or transdermal formulations. The potential advantages of AeroLEF™ include:
1. simple, non-invasive administration,
2. rapid onset of relief that mimic intravenous,
3. extended duration of relief and
4. personalized patient-controlled dosing to match each patient's individual pain experience.
AeroLEF™ has completed a Phase IIa trial for acute pain in post-surgical patients with positive results. In this study, 95% of patients successfully used AeroLEF™ to self administer fentanyl and achieve pain relief. AeroLEF™ demonstrated rapid onset (median time to first perceptible effect: 2.7 min) and sustained effect (average time to subsequent dosing: 3.7 h). A Phase IIb trial for acute pain and a Phase IIb trial for cancer pain are planned for the next years.
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