Variable Dosing
While fentanyl is a commonly used opioid, AeroLEF® uniquely permits patients to directly identify and select the appropriate dose in real-time for each pain episode to achieve both rapid onset and extended duration of analgesia. This represents an entirely new treatment paradigm with an established, approved drug.
Management of acute pain presents a major challenge to physicians. Acute pain is characterized by rapid onset coupled with unpredictable and variable intensity over time, confounded by highly variable patient responses to analgesics, such as opioids, and concerns related to toxicities. Consequently, a successful analgesic dose is extremely difficult to predict and maintain. Existing analgesic delivery systems such as intravenous, oral, transmucosal or transdermal rely on complex dose titration algorithms that require extended periods of time to resolve, during which the patient continues to experience pain. Re-titration to new doses is required as pain intensity changes.
AeroLEF is designed to enable each patient to rapidly achieve analgesia and select the appropriate dose for each pain episode. Inhalation of small doses of free fentanyl in AeroLEF provides very rapid increases in plasma concentrations, thus achieving therapeutic levels quickly. Real-time analgesic feedback can occur during dosing allowing patient-controlled dose selection for each pain episode and optimizing the balance between efficacy and safety. The liposomal-fentanyl extends the duration of action for hours.
