Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery

After elective ACL knee surgery, consented patients will receive a single dose of AeroLEF for moderate/severe acute pain. Patients stop dosing if they achieve analgesia, complete the maximum available dose, or experience dose-limiting side effects.

Inclusion criteria

• Male or female between ages 18 years and 60 years.
• A body mass index of between 18 and 30, inclusive.
• If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
• Scheduled for elective ACL arthroscopic knee repair surgery, and meet the criteria of the American Society of Anesthesiologists [ASA] Physical Status Criteria of Class I or Class II, and suitability for an anesthetic plan limited to general anesthesia (inhalation/IV) with post-operative PCA initiated in a PACU setting and not requiring CPM before the 12 hours post surgery observation is completed.
• Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay.
• Normal laboratory values for clinical chemistry, haematology and urinalysis. If a patient has abnormal clinically significant laboratory values, inclusion will be permitted at the discretion of the investigator .
• Physical examination with no clinically relevant findings as determined by the investigator.
• Able to demonstrate the ability to understand the requirements of the study, willingness to provide written informed consent (prior to any study-related procedures being performed) and able to adhere to the study restrictions, and return for the required assessments.

Exclusion criteria

• History of addiction to drugs or alcohol.
• Exposure to any investigational drug within the 30 days prior to enrolment.
• Documented hypersensitivity to fentanyl or other opioid analgesics
• Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation
• History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, GI, or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study (excluded by ASA I and II categories)
• Currently receiving treatment, or have received treatment in the previous two weeks, with antidepressant or antipsychotic drugs (including monoamine oxidase inhibitors).
• Clinically significant ongoing medical conditions.
• Currently receiving treatment for chronic pain.
• Current therapy with narcotic or CNS-depressant medications.
• Current chronic therapy with NSAIDs, ASA or acetaminophen within the previous 7 days.
• Patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
• Blood donation or other blood loss within 45 days prior to enrolment in the study totalling 100 mL or greater.