FDA approves first fentanyl nasal spray for the management of breakthrough cancer pain

FDA has approved the first and only fentanyl nasal spray (Lazanda, Archimedes) in the United States for the management of breakthrough pain in cancer patients aged 18 years and older who are already receiving opioid therapy to which they are tolerant, for their underlying persistent cancer pain.

Lazanda is marketed as PecFent (fentanyl pectin nasal spray) in Europe, where it is currently available in 5 countries.

Lazanda uses Archimedes’ PecSys drug delivery system, which is designed to deliver the medication in a rapid and controlled manner across the mucus membrane, said to be key for patients.

“We’re going to be collaborating very closely with managed-care payers as we prepare for the launch of Lazanda,” Archimedes spokeswoman Julissa Viana told

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More than half of cancer patients with pain are affected by breakthrough pain; among other things, it is associated with increased hospitalizations and emergency room visits, as well as medical costs close to 3 times higher than costs borne by those without breakthrough pain in cancer, according to Viana.

“Often breakthrough pain in cancer is managed by either increasing the dose of background opioids and/or giving an additional dose of short-acting oral opioid medicines,” Viana said. “However, this approach may not provide an optimal onset and duration of action to match the time course of breakthrough pain in a cancer episode and is not always an efficient and effective way to treat the condition.”

Breakthough pain in cancer is an intense, sudden pain that often is unpredictable and debilitating, and occurs despite otherwise appropriate opioid therapy for background pain. It often has high intensity and a rapid onset, usually reaches maximum intensity within 5 minutes, and is of short duration, lasting between 30 and 60 minutes per episode.

Lazanda will be available in the second half of this year through a Risk Evaluation and Mitigation Strategy (REMS) program.