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Archimedes Pharma Announces Publication of Long-Term Safety and Tolerability Clinical Study of Fentanyl Pectin Nasal Spray (FPNS) in the Journal of Opioid Management
Date:10/12/2010

ly acceptable and consistently effective product for the long-term treatment of BTCP."  He continued, "With our recent launch of PecFent® in the UK and upcoming launches in additional European countries, Archimedes Pharma is providing a new therapy to improve the treatment options for adult patients with breakthrough cancer pain.  An NDA has been submitted with the US Food and Drug Administration and is currently under review."

Notes to editors:About Archimedes PharmaArchimedes Pharma is an international specialty pharmaceutical company focused on the oncology, pain, neurology, and critical care sectors. Archimedes Pharma is marketing an expanding portfolio of specialist products to hospital-based prescribers in Europe and has established commercial organizations in the UK, US, France, Germany, Ireland, and Spain.

Fentanyl Pectin Nasal Spray [called PecFent® in Europe]

PecFent is an innovative fentanyl pectin citrate nasal spray that has been granted Marketing Authorization by the European Medicines Agency for the treatment of breakthrough cancer pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain.  It is under review by the US Food and Drug Administration (FDA).

In the clinical trial program, the use of PecFent in the treatment of breakthrough cancer pain was associated with the occurrence of adverse events typical of opioid medication in this population.  The most frequently reported were vomiting, nausea, disease progression and constipation.  The majority of such events were mild to moderate in intensity, and adverse effects assessed as treatment-related led to study withdrawal in 3.9% of patients.

About Breakthrough Cancer Pain (BTCP)

Breakthrough cancer pain affects 24% to 95% (average across all studies 62%) of all cancer patients with pain and is characterized by sudden, often unpredictable episodes of intense pain that occur despite backgr
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SOURCE Archimedes Pharma
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