FDA Approves First Fentanyl Nasal Spray for Breakthrough Cancer Pain

Archimedes Pharma, Ltd, announced recently that it had received FDA approval for Lazanda (fentanyl) nasal spray for the management of breakthrough pain in adult cancer patients. The drug was approved for patients who are either already receiving or are tolerant to opioid therapy for persistent cancer pain.

Lazanda is the first fentanyl nasal spray approved in the United States. In a news release announcing the approval, Donald Taylor, MD, director at Taylor Research LLC, said Lazanda provides a new approach to managing the “inadequately treated episodes of breakthrough pain that many patients with cancer experience.” Lazanda is expected to be available later this year and will include a Risk Evaluation and Mitigation Strategy (REMS) that will require pharmacies, distributors, and healthcare professionals to enroll in the REMS program to dispense, distribute, and prescribe the drug.

The FDA approval comes in the wake of the publication of several studies in clinical journals demonstrating the effectiveness and tolerability of fentanyl nasal spray in patients suffering from episodes of breakthrough cancer pain. One study, published in the June 2011 issue of CNS Drugs, reported that in 2 randomized, double-blind, crossover trials in opioid-tolerant adults, fentanyl pectin nasal spray (delivered in 100—800 μg titrated doses) was “significantly more effective than placebo in reducing pain intensity and provided a significantly faster onset of pain relief than oral immediate-release morphine.”

In the February issue of the Journal of Pain and Symptom Management, another study compared fentanyl pectin nasal spray to immediate-release morphine sulfate in the treatment of breakthrough cancer pain. The trial enrolled 110 patients who were being treated with ≥60 mg per day of oral morphine for persistent cancer-related pain and who experienced up to 4 breakthrough cancer pain episodes per day. Patients were then randomized to receive either fentanyl pectin nasal spray plus placebo or immediate-release morphine sulfate plus placebo for 5 breakthrough cancer pain episodes each. Researchers assessed pain intensity, pain relief, patient acceptability scores, and adverse events, and found that fentanyl pectin nasal spray “consistently provided relief from pain more rapidly” than immediate-release morphine sulfate. More than 75% of patients in the trial reported being “satisfied” or very satisfied” with the convenience and ease of use of fentanyl pectin nasal spray.

In a final study, investigators evaluated the safety and tolerability of fentanyl pectin nasal spray in more than 400 patients with cancer. Eligible patients were being treated with morphine for background pain and experiencing up to 4 episodes of breakthrough cancer pain each day. The results, published in the March 2011 issue of Supportive Care in Cancer, found that nearly one-quarter (24.6%) of patients in the study reported generally mild/moderate treatment-related adverse events that are typical of opioids. The study also revealed that 94% of breakthrough cancer episodes treated with fentanyl nasal spray required no additional use of rescue medication, and that more than 90% of patients did not have to increase doses during the study.

Lazanda uses the PecSys drug delivery system, which delivers fentanyl rapidly in a fine mist that gels to mucosal surfaces, thereby optimizing the absorption of lipophilic drugs into the blood stream. The manufacturer, Archimedes Pharma, is an international specialty pharmaceutical company that has offices throughout the United States and Europe.

Lyseng-Williamson KA. Fentanyl pectin nasal spray: in breakthrough pain in opioid-tolerant adults with cancer. CNS Drugs. 2011;25(6):511-522.

Davies A, Sitte T, Elsner F, Reale C, Espinosa J, Brooks D, Fallon M. Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain. J Pain Symptom Manage. 2011;41(2):358-366.

Radbruch L, Torres LM, Ellershaw JE, et al. Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain. Support Care Cancer. 2011 Mar 22. [Epub ahead of print]. doi:10.1007/s00520-011-1124-x.