Novel Nasal Spray Formulation of Fentanyl Citrate for Cancer Pain

August 2011, Vol 2, No 5 - FDA Approvals, News & Updates

The US Food and Drug Administration (FDA) approved a new nasal spray formulation of fentanyl citrate (Lazanda; Archimedes) for the rapid relief of cancer-related breakthrough pain in adults who have developed resistance to their opioid regimen.

The recommended dosage is 100 μg sprayed once in each nostril for each cancer-related pain episode. If adequate analgesia is not obtained within 30 minutes, the dose should be titrated up with each subsequent episode.

Approval was based on evidence from 500 patients enrolled in a doubleblind, placebo-controlled clinical trial that included an open-label titration phase. Pain relief was maintained for 60 minutes after dosing. During the titration phase, 73% of patients obtained adequate relief. The most common adverse events were nausea, vomiting, pyrexia, and dizziness.

The nasal spray formulation, which is approved with a Risk Evaluation and Mitigation Strategy program, will become available in the second half of this year. (June 30, 2011)