Fentanyl Nasal Spray Beats Oral Opioid for Control of Breakthrough Cancer Pain

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CHICAGO—A fentanyl pectin nasal spray provides analgesia faster than immediate-release morphine in the treatment of breakthrough cancer pain, said Andrew Davies, MD, MSc at the 46th American Society of Clinical Oncology annual meeting.
Breakthrough cancer pain is a transient exacerbation of pain that occurs despite relatively stable and adequately controlled background pain and has a significant impact on quality of life.
Forty to 80% of patients with cancer pain have breakthrough pain, which tends to be rapid in onset, often peaking at approximately 3 minutes, and short in duration, lasting a median of 30 minutes,Davies explained.
“For most patients, the mainstay of treatment is the use of so-called ‘rescue medications,’” he said. “Throughout the world, an oral opioid [oral immediate-release morphine] is the standard of care.” Unfortunately, said Davies, the pharmacokinetic/pharmacodynamic profile of oral immediate-release morphine does not fit the temporal characteristics of breakthrough cancer pain. It takes 20 to 30 minutes to start to work and 60 minutes for it speak effect.
In contrast, fentanyl pectin nasal spray has pharmacokinetics that enable rapid onset of pain relief, which facilitates rapid but controlled absorption of fentanyl across the nasal mucosa.
In a phase 3, double-blind, double-dummy multiple crossover study, patients who had one to four episodes of breakthrough cancer pain per day while taking at least 60 mg/day of morphine sulfate were randomized to fentanyl nasal spray or morphine sulfate. Seventy-nine patients who completed the treatment phase were included the efficacy and safety analysis, representing 740 pain episodes.
In the double-blind, double-dummy phase, 10 episodes of breakthrough cancer pain were randomly treated with fentanyl nasal spray and oral placebo or immediate-release morphine sulfate and nasal spray placebo.
Pain intensity on an 11-point scale was measured up to 60 minutes. Pain intensity from baseline to 15 minutes, the primary end point of the study, was improved by 3.02 points in patients assigned to fentanyl nasal spray compared with 2.69 for immediate-release morphine (P <.05). “This difference was maintained throughout the 60-minute period of study,” said Davies, consultant in palliative medicine, The Royal Marsden Foundation Trust, Surrey, United Kingdom.
Clinically meaningful pain relief, defined as a two- point or greater decrease in pain intensity, was superior at both 10 and 15 minutes in the fentanyl nasal spray group. At 10 minutes, clinically meaningful pain relief was achieved by 52.4% of patients randomized to fentanyl nasal spray compared with 45.4% of those randomized to immediate-release morphine (P <.05), and at 15 minutes, 75.5% of the fentanyl nasal spray group versus 69.3% of the immediate-release morphine group had clinically meaningful pain relief (P <.05).
Patients were either satisfied or very satisfied with fentanyl nasal spary for 81.5% of pain episodes versus 71.2% with immediate-release morphine (P <0.05).
The most common adverse effects attributed to fenatnyl nasal spray were typical opioid adverse effects, such as vomiting and somnolence; these were more common than with oral immediate-release morphine. Most side effects with fenatanyl nasal spray were mild to moderate and none were dose-related.

Only 4.7% of patients withdrew from titration (2.4% in double-blind/double-dummy phase) due to adverse events; no significant nasal effects were reported.

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