Archimedes Pharma U.S. Inc. announced that the FDA has approved Lazanda (fentanyl) nasal spray for the management of breakthrough pain in cancer patients ≥18 years who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. Lazanda will be available in the second half of 2011 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.

Lazanda contains fentanyl, which is a Schedule II controlled substance, and uses Archimedes Pharma’s patented drug delivery system, PecSys.

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