READING, England, and BEDMINSTER, N.J. — Archimedes Pharma Ltd. and its subsidiary, Archimedes Pharma U.S. Inc., have rolled out Lazanda fentanyl nasal spray to U.S. pharmacies.

The company said Monday that the Food and Drug Administration approved Lazanda on June 30, marking the first product approval for Archimedes Pharma in the United States and the first fentanyl nasal spray in the nation.

Lazanda is 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.

The medication uses Archimedes’ patented PecSys drug delivery system, which allows the active ingredient to be rapidly absorbed across the nasal membrane and directly into the blood stream. Lazanda is marketed as PecFent (fentanyl pectin nasal spray) in Europe, where it is currently available in six countries.

"As the first and only treatment option in the U.S. offering fentanyl through nasal administration, Lazanda provides clinically proven pain relief to adult cancer patients suffering from breakthrough pain," stated Jeffrey Buchalter, chief executive officer of Archimedes Pharma. "The availability of Lazanda also is an exciting milestone for Archimedes Pharma, as it marks our first product launch in the U.S. and represents the expansion of the brand from Europe."

Breakthrough pain is experienced by over half of cancer patients who have pain and can be debilitating and disrupt in daily living activities, according to Archimedes. Unlike the constant background pain many cancer patients experience, breakthrough pain is an intense, excruciating pain with rapid onset and relatively short duration, and it occurs despite taking opioid therapy for background pain, the company said.

"Even though the incidence of breakthrough pain is high in cancer patients, it is often not correctly identified nor reported," commented Nash Gabrail, M.D., of the Gabrail Cancer Center and clinical investigator for Lazanda. "If reported, it is typically managed by either increasing the dose of background opioids or giving an additional dose of a short-acting oral opioid, neither of which is optimal therapy. Lazanda, with its rapid and controlled availability, can provide pain relief with an onset of action and duration of effect that addresses the time course of a typical breakthrough pain episode."

Lazanda is available 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.