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.
Phase III, double-blind, 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%]).
Of course, Onsolis (Fentanyl Buccal Film) was approved by the FDA back in July “for the management of breakthrough pain in patients with cancer aged 18 years and older who receive around-the-clock opioid therapy and are able to safely use high doses of additional opioid agents.”
"Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death," said Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, in an agency news release. "For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required [risk evaluation and mitigation strategy] and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications."