(RxWiki News) Breakthrough pain in cancer can come on suddenly without warning and be debilitating. It's so intense that even narcotic pain killers don't touch it. Cancer patients now have a new alternative.
The U.S. Food and Drug Administration (FDA) has approved Lazanda (fentanyl) nasal spray for treating breakthrough pain in cancer patients who can't find relief from opioid therapies (morphine, and its derivatives).
"FDA approves Lazandra nasal spray to treat breakthrough pain in cancer."
Breakthrough pain in cancer (BTPc) can be so excruciating that it interferes with daily living. It's different from so-called background pain in that it's unpredictable, reaches maximum intensity within five minutes and lasts 30-60 minutes. It's thought that nearly half of all patients with cancer experience BTPc.
Lazandra is manufactured by Archimedes Pharma Ltd. and its subsidiary, Archimedes Pharma U.S. Inc. It contains fentanyl, a Schedule II controlled substance that uses Archimedes Pharma's patented drug delivery system, PecSys.
As the first fentanyl nasal spray available in the United States, Lazandra works rapidly to provide pain relief. In announcing its FDA approval, Donald Taylor, M.D., director at Taylor Research LLC., and clinical investigator for Lazanda says the medication gives physicians a "new and powerful tool for treating cancer breakthrough pain."
The medication is currently available in five European countries under the brand name PecFent (fentanyl pectin nasal spray).
The medicine will be available in the U.S. in second half of 2011 through the Lazandra Risk Evaluation and Mitigation Strategy (REMS) program. This system is designed to minimize the risks associated with taking the medication, including misuse, abuse, addiction and overdose and serious complications that may be caused by medication errors.
Anyone working with Lazandra - pharmacies, distributors and health care professionals treating outpatients - must be enrolled in the program to dispense, distribute and prescribe Lazanda.