Pharmacy Medical News about breakthrough pain; cancer; intranasal fentanyl spray

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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, 08/19/09

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

Results

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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