EC approves PecFent for cancer pain

The European Commission (EC) has granted Archimedes Pharma marketing authorisation for PecFent (fentanyl), a nasal spray for the treatment of breakthrough cancer pain (BTCP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain.

Fentanyl is a highly potent opioid analgesic, which, when administered through Archimedes' nasal drug delivery system can provide rapid relief for breakthrough cancer pain. Episodes of BTCP are unpredictable and can be extremely severe. They typically reach their maximum intensity within five minutes and can last between 30 minutes and an hour.

Data from two separate phase III clinical trials has shown PecFent to demonstrate the onset of pain relief as early as five minutes after administration and to have provided clinically meaningful pain relief within 10 minutes.

Professor Marie Fallon, St Columba's Hospice chair of palliative medicine, University of Edinburgh said: "The availability of this significant innovation is very important. Being a nasal spray, its ease of use allows patients to treat their breakthrough cancer pain episodes conveniently, wherever they are, and its unique delivery system provides fast onset of pain relief meaning they can manage these episodes effectively. This is absolutely crucial for cancer patients and PecFent offers real hope for an improvement in their quality of life."

In total, three phase III trials provided the data from which the marketing authorisation was granted. These included an active comparator study and a large long-term safety and acceptability study. Over 650 patients from 13 countries including France, Germany, Italy, Spain, UK and US participated in the programme.

Jeffrey H Buchalter, president and CEO of Archimedes Pharma, said: "The grant of European marketing authorisation for PecFent provides a new therapy to improve the treatment options for adult patients with breakthrough cancer pain. This is also a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months."

A New Drug Application (NDA) for PecFent was submitted to the US Food and Drug Administration (FDA) in August 2009. The company is in the process of establishing a US commercial organisation to market the drug in that market once approved.