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Fentanyl: Again, REMS is <strong>the</strong> Big Regulatory Hurdle<br />
• Fentora (Cephalon)<br />
– Follow-on to Actiq – first launched in 1999 for breakthrough cancer pain.<br />
– 80-90% of Actiq use off label in o<strong>the</strong>r forms of breakthrough pain.<br />
– Fentora launched in late 2006 (as Actiq went generic).<br />
– Unsuccessful FDA panel meeting in May 2008 to broaden indication; adapting<br />
REMS and will try again in 2010.<br />
• BEMA Fentanyl (BioDelivery Sciences)<br />
• Received complete response letter in Aug, 2008.<br />
• Need to complete a REMS program.<br />
• Approval anticipated in 1H 2009 for breakthrough cancer pain; will be marketed<br />
by MEDA.<br />
• O<strong>the</strong>r fast-acting fentanyls reportedly in development<br />
• Stacatto fentanyl, inhaled (Alexza); licensed to Endo, starting Phase II.<br />
• Taifun fentanyl, inhaled (Akela); finished Phase II.<br />
• Intranasal fentanyl (Nycomed): filed in Europe in 2007.<br />
• Rapinyl (Prostakan - from Endo); Phase III<br />
• Intranasal fentanyl (Archimedes); Phase III<br />
• Oral spray (NovaDel); Pre-clin<br />
Natixis Bleichroeder <strong>presentation</strong>, Arrowhead Pain Conference 2008<br />
© Defined Health, 2009<br />
57<br />
Pain Insight Briefing
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