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Efficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough pain in patients with cancer: A phase III, multinational, randomized, double-blind, placebo-controlled, crossover trial with a 10-month, open-label extension treatment period
Clinical Therapeutics, 08/26/09
Kress HG et al. – Intranasal fentanyl spray (INFS), at 50, 100, and 200 micrograms, was associated with an onset of activity at 10 min and effective tx of breakthrough pain compared with placebo.
Methods- Phase III, double-bline, randomized, placebo-controlled, crossover trial
- 120 adults with cancer receiving a stable dose of long-term opioid tx for the control of background pain
- Patients were treated at home with 50, 100, or 200 micrograms of INFS or placebo for 3 weeks, followed by a 10-month, phase when they received their effective dose of INFS
- The pain intensity difference at 10 minutes (PID10) with INFS was 2-fold that with placebo
- The mean response rate with all 3 doses of INFS was 51.1% vs. 20.9% with placebo
- The prevalence of AEs was 19.8% (nausea [4.5%] and vertigo [1.8%])
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Today in Pain Management/Palliative Care...keeping you current
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