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 “who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.” Lazanda is the first fentanyl nasal spray approved in the US. In a news release announcing the approval (http://hcp. lv/n7s5Yv), 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 REMS that will require “pharmacies, distributors, and health care professionals who prescribe to outpatients” to enroll in the REMS program to dispense, distribute, and prescribe the drug. Lazanda uses the PecSys drug delivery system, “a proprietary pectin-based drug delivery system designed to gel when applied to mucosal surfaces and … optimize absorption of lipophilic drugs into the systemic circulation” (http://hcp.lv/oijIDa).

The FDA approval comes in the wake of the publication of several studies in clinical journals in the past several months demonstrating the effectiveness and tolerability of fentanyl nasal spray in patients suffering from episodes of breakthrough cancer pain. In “Fentanyl Pectin Nasal Spray: In Breakthrough Pain in Opioid-tolerant Adults with Cancer,” published in the June 1, 2011, issue of CNS Drugs (http://hcp.lv/ qrrAGm), researchers studying the efficacy of fentanyl pectin nasal spray (marketed as PecFent in Europe and recently approved as Lazanda in the US) for the treatment of breakthrough pain in cancer reported that in two 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.” They also reported that fentanyl pectin nasal spray “consistently provided effective pain relief during long-term treatment of breakthrough pain in cancer patients. In trials, the drug was generally well tolerated and was not associated with “nasal tolerability problems.”

Earlier this year, researchers studying the “consistency of efficacy, tolerability, and patient acceptability” of fentanyl pectin nasal spray compared to immediate-release morphine sulfate in the treatment of breakthrough cancer pain published their findings in the February 2011 issue of the Journal of Pain and Symptom Management in an article titled “Consistency of Efficacy, Patient Acceptability, and Nasal Tolerability of Fentanyl Pectin Nasal Spray Compared with Immediate-Release Morphine Sulfate in Breakthrough Cancer Pain” (http://hcp.lv/ oCQAt7). In the trial, patients who were being treated with 60 mg or more per day of oral morphine for persistent cancer-related pain and who experienced up to four breakthrough cancer pain episodes per day were randomized to receive either fentanyl pectin nasal spray plus placebo or immediate-release morphine sulfate plus placebo for five breakthrough cancer pain episodes each. Researchers assessed pain intensity, pain relief, “patient acceptability scores,” and adverse events. They found that fentanyl pectin nasal spray “consistently provided relief from pain more rapidly” than immediate-release morphine sulfate, as quickly as 10 minutes after the drugs were administered. Patients reported “significant differences” in pain intensity scores and number of episodes of “meaningful pain relief” with fentanyl pectin nasal spray compared to 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.

Researchers studying the safety and tolerability of fentanyl pectin nasal spray in more than 400 patients with cancer being treated with morphine for background pain and experiencing up to four episodes of breakthrough cancer pain each day published their results in the March 2011 issue of Supportive Care in Cancer (http://hcp.lv/ nZbf7U). In their article, titled “Long-term Tolerability, Efficacy and Acceptability of Fentanyl Pectin Nasal Spray for Breakthrough Cancer Pain,” the researchers wrote that nearly one-quarter (24.6%) of patients in the study reported “treatment-related treatmentemergent AEs that were generally mild/ moderate and typical of opioids.” They also revealed that 94% of breakthrough cancer episodes treated with fentanyl nasal spray required no addition use of rescue medication, and that “more than 90% of patients did not have to increase their dose during the study.”