YM BIOSCIENCES RELEASES RESULTS OF INHALED ANALGESIC STUDY

YM BioSciences has announced results from the open-label portion of its Phase IIb trial of AeroLEF. The results demonstrated that the majority of the patients were able to achieve effective analgesia for episodes of moderate to severe acute postsurgical pain by self-titrating the amount of medication they inhaled using AeroLEF. Results of the study were presented at the American Society of Anesthesiologists Annual Meeting.

AeroLEF is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. AeroLEF is designed to permit patients to match dosage to their individual pain intensity and experience rapid and extended pain relief.

The Phase IIb trial consists of two parts. Part I was an open-label trial designed to allow investigators to gain familiarity with administration of the product. Part I enrolled 21 patients who underwent a variety of elective orthopedic surgical procedures at eight centers. Part II, currently under way, is a randomized, double-blind, and placebo-controlled trial of 99 patients and is designed to evaluate the safety and efficacy of AeroLEF compared with placebo for management of pain following elective orthopedic surgery.

In Part I of the study, patient self-titrated dosing with AeroLEF provided clinically meaningful analgesia in 81 percent, 100 percent and 87.5 percent of treated pain episodes during doses one, two and three, respectively. Within 10 minutes of initiating dosing with AeroLEF, 38 percent, 73 percent and 63 percent of patients reported a reduction in pain intensity to mild pain during doses one, two and three, respectively. Achieving effective pain relief was the reason for stopping AeroLEF dosing in 88 percent treated pain episodes.

Study results also suggested that multiple doses of AeroLEF were well-tolerated. No treatment-emergent adverse events were reported in 43 percent of patients. The majority of treatment-emergent adverse events were mild and considered typical of those associated with opioid analgesia in the postoperative setting. Adverse events of a respiratory nature were reported in four patients.