The FDA has approved Archimedes Pharma’s Lazanda fentanyl nasal spray for the treatment of breakthrough pain in cancer patients 18 years old and older. The product is already marketed in five European countries, where it is called PecFent.
“Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain,” said Jeffrey Buchalter, CEO of Archimedes Pharma. “Lazanda, which uses our patented PecSys drug delivery system, is designed to deliver medicine in a rapid, but controlled manner, and provides patients with an effective alternative to manage their breakthrough pain.”
According to Archimedes, “Lazanda will be available in the second half of this year through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors. Under the Lazanda REMS program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to dispense, distribute, and prescribe Lazanda.”
“We fully support the FDA mandate to implement a REMS program for Lazanda as an important way to provide patients, healthcare providers, and pharmacists with the information they need about the appropriate and safe use of Lazanda. Archimedes Pharma looks forward to working closely with health care professionals to ensure safe and consistent access to Lazanda for the patients who are seeking relief from unbearable episodes of breakthrough pain in cancer.”
Read the Archimedes press release.
