Archimedes Pharma Ltd., and its subsidiary, Archimedes Pharma US Inc., announced that Lazanda (fentanyl) nasal spray is now available by prescription in US pharmacies. 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 US Food and Drug Administration approved Lazanda on June 30, 2011, marking the first product approval for Archimedes Pharma in the US and the first fentanyl nasal spray in the US.
Breakthrough pain, experienced by more than half of patients with cancer who have pain, can be debilitating to patients and interfere with their ability to engage in daily living activities. Different from the constant background pain many patients with cancer experience, breakthrough pain is described as an intense, excruciating pain with rapid onset and relatively short duration, which occurs despite taking appropriate opioid therapy for background pain.
"Even though the incidence of breakthrough pain is high in cancer patients, it is often not correctly identified nor reported," said Nash Gabrail, MD, MRCP, 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 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 presently available in six countries.
"As the first and only treatment option in the US offering fentanyl through nasal administration, Lazanda provides clinically proven pain relief to adult cancer patients suffering from breakthrough pain," noted Jeffrey H. 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."
Lazanda will be available through a Risk Evaluation and Mitigation Strategy (REMS) programme, which is intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors. Under the Lazanda REMS programme, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enrol in the programme to dispense, distribute, and prescribe Lazanda.
Lazanda contains fentanyl, which is a Schedule II controlled substance, and uses Archimedes Pharma's patented drug delivery system, PecSys.
Lazanda, incorporating PecSys technology, delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to a mucus membrane, in this case the nasal membrane. Each spray of Lazanda forms a gel when it contacts the nasal mucosa; the active ingredient is then rapidly absorbed across the mucus membrane and directly into the blood stream.
The efficacy of Lazanda for the management of breakthrough pain in adult cancer patients was established in a double-blind, placebo-controlled clinical study in patients receiving opioid therapy for background pain, in which Lazanda showed a statistically significant improvement compared with placebo on the primary endpoint, the sum of the pain intensity difference at 30 minutes (SPID30). More than 500 patients evaluated in the clinical trial program (which included three phase III clinical trials) contributed to the understanding of the tolerability and safety profile of Lazanda. The most common adverse events associated with Lazanda were consistent with opioid treatment and included vomiting, nausea, pyrexia (fever), and constipation.
Archimedes Pharma is an international specialty pharmaceutical company providing novel and advanced treatments to address unmet needs for people living with serious or life-threatening chronic and debilitating illnesses.