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FDA Approved Drugs » 2011
Medical Areas: Neurology | Oncology | Family Medicine
View By:Year | Company | Conditions | Therapeutic Areas | Drug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved June 2011
Treatment Area: breakthrough cancer pain
Lazanda is a nasal spray formulation of fentanyl citrate, a highly effective opiate analgesic that has been shown to provide rapid onset and short duration of action.
Lazanda is specifically indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. For this reason, Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency department.
Lazanda is supplied as a solution for intranasal administration. The appropriate dose of Lazanda must be determined by dose titration and is based on the individual patient’s effective and tolerable dose.Starting Dose: Individually titrate Lazanda to a dose that provides adequate analgesia with tolerable side effects. Begin treatment of all patients (including those switching from another fentanyl product) using ONE 100 mcg spray of Lazanda (1 spray in one nostril). If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg single spray, treat subsequent episodes of breakthrough pain with this dose.Titration steps: If adequate analgesia is not achieved with the first 100 mcg, dose, dose escalate in a step-wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved. Patients must wait at least two hours before treating another episode of breakthrough cancer pain with Lazanda.
FDA ApprovalThe FDA approval of Lazanda was based on a clinical trial consisting of an open-label titration phase and a double-blind, placebo-controlled phase. In the open label phase a dose was identified that provided adequate analgesia with tolerable side effects, within the range of 100 to 800 mcg. In the double-blind, placebo-controlled phase, the subjects who were titrated to an adequate dose were randomized to a blinded sequence of 10 treatments, seven treatments with the identified dose of Lazanda and three with placebo. Of the subjects who enrolled in the study, 73% achieved an adequate dose during the titration phase. The primary outcome measure, the mean sum of the pain intensity difference at 30 minutes (SPID30), was statistically significantly higher for Lazanda than for placebo. This improvement in pain was maintained for 60 minutes after dosing.
Adverse events associated with the use of Lazanda during the titration phase may include, but are not limited to, the following:
Adverse events associated with the use of Lazanda during the maintenance phase may include, but are not limited to, the following:
Radbruch L, Torres LM, Ellershaw JE, Gatti A, Luis Lerzo G, Revnic J, Taylor D Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care 2011 Mar 22
Portenoy RK, Raffaeli W, Torres LM, Sitte T, Deka AC, Herrera IG, Wallace MS; Fentanyl Nasal Spray Study 045 Investigators Group Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients. Journal of Opoid Management 2010 Sep-Oct;6(5):319-28
Portenoy RK, Burton AW, Gabrail N, Taylor D; Fentanyl Pectin Nasal Spray 043 Study Group A multicenter, placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain. Pain 2010 Dec;151(3):617-24
For additional information regarding Lazanda or breakthrough cancer pain, please visit the Lazanda web page.
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