FDA Approves Lazanda - Drug Discovery and Development

Archimedes Pharma Ltd., and its subsidiary, Archimedes Pharma U.S. Inc., announced the U.S. Food and Drug Administration (FDA) has approved Lazanda (fentanyl) nasal spray for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.

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, 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,” says Jeffrey H. Buchalter, chief executive officer of Archimedes Pharma.

Breakthrough pain in cancer (BTPc) is an intense, sudden pain that is often unpredictable and debilitating and occurs despite otherwise appropriate opioid therapy for background pain. BTPc has a different profile from background pain.

“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,” says Donald Taylor, MD, 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 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.

Release Date: June 30, 2011
Source:Archimedes Pharma Ltd