Archimedes Pharma and its subsidiary, Archimedes Pharma U.S., have won FDA approval of LazandaR (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 is the first FDA product approval for Archimedes Pharma. Lazanda is marketed as PecFentR in Europe, where it is available in five countries.
"Lazanda, which uses our patented PecSysR 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,” said Jeffrey H. Buchalter, CEO of Archimedes Pharma.
Breakthrough pain in cancer (BTPc) is a sudden, unpredictable and debilitating pain that occurs despite otherwise appropriate opioid therapy for background pain. BTPc has a different profile from background pain, often with 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.
Lazanda will be available in the second half of 2011 through a Risk Evaluation and Mitigation Strategy (REMS) program, intended to minimize the risk of misuse, abuse, addiction, overdose and complications due to medication errors. Under the LazandaR REMS program, pharmacies, distributors and healthcare professionals who prescribe to outpatients are required to enroll to dispense, distribute and prescribe Lazanda.