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FDA Approves Lazanda® - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
Date:6/30/2011

READING, England and BEDMINSTER, N.J., June 30, 2011 /PRNewswire/ -- Archimedes Pharma Ltd., and its subsidiary, Archimedes Pharma U.S. Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Lazanda® (fentanyl) nasal spray 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.  Lazanda marks the first FDA product approval for Archimedes Pharma. Lazanda is marketed as PecFent® (fentanyl pectin nasal spray) in Europe, where it is presently available in five countries.

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"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."

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.

"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
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SOURCE Archimedes Pharma Ltd.
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