Archimedes Pharma Ltd. and its subsidiary Archimedes Pharma U.S. Inc. have been cleared by the U.S. Food and Drug Administration to market approved Lazanda (fentanyl) nasal spray, for the management of breakthrough pain in cancer patients.


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Archimedes gets OK for fentanyl nasal spray

July 1st, 2011

READING, England, and BEDMINSTER, N.J. – Archimedes Pharma Ltd. and its subsidiary Archimedes Pharma U.S. Inc. have been cleared by the U.S. Food and Drug Administration to market approved Lazanda (fentanyl) nasal spray, for the management of breakthrough pain in cancer patients.

Archimedes said late Thursday that Lazanda marks the first FDA product approval for Archimedes Pharma. Lazanda is marketed as PecFent (fentanyl pectin nasal spray) in Europe, where it is available in five countries.

Lazanda fentanyl nasal spray is indicated for cancer patients 18 years of age and older who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain, according to the company.

"Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain," stated Jeffrey Buchalter, chief executive officer 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."

Breakthrough pain in cancer on average affects more than half of patients with cancer and often interferes with patients' health and ability to engage in daily living activities, Archimedes noted.

"As the first fentanyl nasal spray in the U.S., Lazanda provides a new approach to managing the often debilitating and inadequately treated episodes of breakthrough pain that many patients with cancer experience," commented Donald Taylor, M.D., director at Taylor Research LLC and clinical investigator for Lazanda. "Current treatment options typically utilize short-acting oral opioid medications that cannot provide pain relief with an onset of action or duration of effect that matches the time course of a BTPc episode. Lazanda's rapid and controlled availability is a much better match for the nature of an episode of breakthrough pain, giving physicians a new and powerful tool for treating cancer breakthrough pain."

Lazanda is slated to be available in the second half of this year through a Risk Evaluation and Mitigation Strategy (REMS) program, designed 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 Lazand, Archimedes said.

"We fully support the FDA mandate to implement a REMS program for Lazanda as an important way to provide patients, health care providers, and pharmacists with the information they need about the appropriate and safe use of Lazanda," added Buchalter.

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