The U.S. Food and Drug Administration (FDA) has approved a fentanyl nasal spray (Lazanda?, Archimedes Pharma Ltd/Archimedes Pharma U.S. Inc) 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.

This marks the first FDA product approval for Archimedes Pharma.

The new drug contains fentanyl, an opioid agonist and a Schedule II controlled substance, and uses Archimedes Pharma’s patented drug delivery system, PecSys? which delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to a mucus membrane (the nasal membrane).

Each spray with fentanyl nasal spray 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.

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Axplora

Trial Results
The efficacy of the drug for the management of breakthrough pain in adult cancer patients was established in a double-blind, placebo-controlled clinical study in which fentanyl nasal spray 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). The most common adverse events associated with Lazanda were consistent with opioid treatment and included vomiting, nausea, pyrexia (fever), and constipation.

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An important new option
“Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain,” says Jeffrey H. 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.”

Unpredictable and debilitating pain
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. BTPc often has high intensity, a rapid onset, usually reaching maximum intensity within five minutes, and a short duration, lasting between 30 and 60 minutes per episode. On average, BTPc affects more than half of patients with cancer and often interferes with patients’ health and ability to engage in daily living activities.

Current treatment options
“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,” said 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.”

Risk Evaluation and Mitigation Strategy
The new drug 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,” said Buchalter. “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.”

Lazanda is marketed as PecFent? (fentanyl pectin nasal spray) in Europe, where it is presently available in five countries.

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