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Title: Actiq (Oral Transmucosal Fentanyl Citrate) Provides Option for Breakthrough Cancer Pain: Presented at APS

"Actiq (Oral Transmucosal Fentanyl Citrate) Provides Option for Breakthrough Cancer Pain: Presented at APS"

By Jill Stein Special to DG News BALTIMORE, MD -- March 15, 2002 -- Actiq® (oral transmucosal fentanyl citrate; OTFC®) is an effective and well-tolerated treatment for the long-term management of patients with breakthrough cancer pain, researchers said at the 21st Annual Scientific Meeting of the American Pain Society (APS). Dr. Richard Payne, with Memorial Sloan- Kettering Cancer Center in New York City, and colleagues examined the long-term efficacy and tolerability of Actiq in an open-label study of opioid-tolerant cancer outpatients who had safely completed Actiq phase III trials. In the open-label study, patients started Actiq at the same dose they attained during successful titration. Subjects continued treatment with around-the-clock opioids for persistent pain. These included sustained-release morphine, transdermal fentanyl, methadone, sustained-release oxycodone, hydromorphone, oxycodone, or immediate-release morphine. Data were available for 156 patients. Overall, patients used 83,156 units of Actiq to treat 77,437 episodes of breakthrough pain. During the first month of the trial, the mean number of daily breakthrough pain episodes was 2.7, of which 93 percent were successfully treated with a single Actiq dose. Patients using Actiq for more than nine months experienced an average of 3.8 episodes of breakthrough pain each day, 92 percent of which were successfully treated with one Actiq dose. More than half the patients (55 percent) had the same last dose as their initial dose. Initial and last Actiq doses exceeding 600 µg were used in 55 percent and 64 percent of patients, respectively. Mean Global Medication Performance (GMP) ratings of Actiq, which patients recorded in daily diaries, remained above "very good" throughout the study. Side effects thought to be possibly related to Actiq treatment were those typically associated with opioids and included nausea (10 percent), somnolence (9 percent), dizziness (8 percent), and vomiting (7 percent). Dr. Payne said the data demonstrate that Actiq is a useful option for the long-term management of breakthrough pain in opioid-tolerant cancer patients. Actiq is a novel product designed to deliver rapid analgesia, within five to 10 minutes, to opioid-tolerant patients who experience breakthrough pain. To permit individualization of dosing, Actiq is available in six dosage strengths (200 µg, 400 µg, 600 µg, 800 µg, 1200 µg, and 1600 µg). The effective dose of Actiq is determined using an individualized titration process. Titration is considered successful when one Actiq unit reliably provides analgesia, with acceptable side effects, for each episode of breakthrough pain experienced over a period of several days. This study was supported by Cephalon, Inc., of West Chester, Pennsylvania.

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