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Title: Intranasal Fentanyl Alleviates Breakthrough Cancer Pain: Presented at WCP

"Intranasal Fentanyl Alleviates Breakthrough Cancer Pain: Presented at WCP"

By Sara Freeman GLASGOW, United Kingdom -- August 26, 2008 -- Intranasal fentanyl is effective for treatment of breakthrough pain in patients with cancer who are receiving chronic opioid therapy, according to phase 3 trial data presented here at the 12th World Congress on Pain (WCP). Stein Kaasa, MD, St. Olavs Hospital and Institute of Cancer Research and Molecular Medicine, Trondheim, Norway, and colleagues presented the findings from the 159-patient study in a poster session on August 22. Breakthrough pain is a common problem in patients with cancer despite continuous treatment aimed at easing background pain levels. While oral formulations of morphine, oxycodone, and hydromorphine are often given to ease this pain, these drugs can take up to 30 minutes to start working and then a further 1 to 2 hours to achieve maximum effects. "Intranasal fentanyl is a promising route for the treatment of breakthrough pain episodes in patients with cancer," said Dr. Kaasa and colleagues. Their study looked at patients who were experiencing 3 to 4 episodes of breakthrough pain per week and receiving 60 to 500 mg of oral morphine per day or 20 to 200 mcg/hour of transdermal fentanyl. To assess the efficacy and safety of intranasal fentanyl, the researchers studied 8 episodes of breakthrough pain per patient. Each patient was treated using a pack of 8 nasal sprays, which contained 2 placebo sprays and 2 sprays each of intranasal fentanyl 50, 100, and 200 mcg. The sprays in each pack were numbered, and patients and their doctors were not aware of which spray was being used for a given episode. Pain was assessed using an 11-point numerical rating scale (0 = no pain; 11= the worst pain) and the difference in scores within the first 10 minutes was used to identify responders. Patients were defined as responders if they had a pain intensity difference score at 10 minutes (PID[₁₀) of more than 2 for a given episode of breakthrough pain.

Response rates for the 50-, 100-, and 200-mcg intranasal fentanyl doses and placebo were 29.05%, 41.55%, 49.66%, and 22.07%, respectively. Fewer patients treated with intranasal fentanyl required rescue medication to manage their breakthrough pain (33%, 25%, and 16.7%, respectively) compared with placebo-treated patients (43.3%).

Adverse events rates were predominantly mild to moderate in nature, with at least 1 adverse event reported in 8.2% of placebo-treated patients and in 9.5%, 7.4%, and 7.4% of patients treated with 50-, 100-, and 200-mcg doses of intranasal fentanyl, respectively. The most common treatment-related adverse event was nausea or vomiting, occurring in about 2% of patients in each active treatment group.

"All doses were efficacious and well tolerated for patients regardless of their background opioid use," Dr. Kaasa and team concluded.

They suggested that the analgesic profile of intranasal fentanyl together with its fast onset of action make it a particularly valuable addition to the management of breakthrough cancer pain.

Funding for this study was provided by Nycomed.

[Presentation titles: Intranasal Fentanyl for Relief of Breakthrough Pain in Patients With Cancer. Abstract PF064] and [The Efficacy of Intranasal Fentanyl Treatment of Breakthrough Pain in Cancer Patients Evaluated in a Randomised Double Blind Study. Abstract PF063]

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