READING, England, June 25, 2010 /PRNewswire/ — Archimedes
Pharma (“Archimedes”), a leading specialty pharma company, today
announced that its lead product, PecFent*, has received a Positive
Opinion from the Committee for Human Medicinal Products (CHMP), of
the European Medicines Agency (EMA). The CHMP is recommending
PecFent, an innovative fentanyl nasal spray, be authorised for
marketing in European Union countries for the treatment of
breakthrough cancer pain (BTCP) – sudden, unpredictable episodes of
intense pain that occur despite background pain medication.
Jeffrey H. Buchalter, President
and Chief Executive Officer of Archimedes Pharma, commented: “This
is a defining moment for Archimedes Pharma. Breakthrough cancer
pain is a poorly served indication and affects up to 95% of all
cancer patients with pain. Today’s announcement by the CHMP is an
important step towards bringing a new treatment option to these
patients in Europe. It also marks
a step change in scale for Archimedes Pharma’s already successful
European commercial operations and an important landmark in our
development as a leading global specialty pharma company. Our
clinical development programme delivered excellent results and we
look forward to delivering this new option for patients in Europe as soon as we can following the
grant of the Marketing Authorisation.”
PecFent is an aqueous fentanyl citrate solution using Archimedes
Pharma’s proprietary PecSys(TM) technology to allow fentanyl to be
retained on the nasal mucosa and is designed to produce rapid but
controlled absorption into systemic circulation. The positive
opinion is based on the results of Archimedes Pharma’s
comprehensive clinical development programme for
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