UK drugmaker Archimedes Pharma will be corking the champagne after receiving a regulatory green light to market its flagship pain spray PecFent (formerly NasalFent) throughout the European Union.
As expected, the European Commission has issued a stamp of approval for the use of PecFent - an innovative nasal spray formulation of the powerful painkiller fentanyl – as a treatment of breakthrough cancer pain (BTCP) in adults already receiving maintenance therapy with an opioid for the condition.
As the name suggests, BTCP is characterised by sudden, severe bouts of pain able to break through continuous background analgesic medication, which typically last for 30 minutes to an hour.
The condition affects about 95% of all patients experiencing chronic cancer pain, and Archimedes will be hoping that its product is able to snap up a considerable share of the market, particularly as existing, rival treatments have significant limitations.
For one, standard therapy with oral opioids can take 20-30 minutes to take effect, by which point the BTCP episode may be coming to an end, while in clinical trials PecFent had an onset of effect within five minutes and clinically meaningful pain relief within just 10 minutes.
According to Professor Marie Fallon, St Columba's Hospice Chair of Palliative Medicine, University of Edinburgh, the availability of PecFent 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 so they can manage these episodes effectively,” she explained, and added that PecFent “offers real hope for an improvement in their quality of life”.
For Archimedes the approval of PecFent also marks a “transformative milestone”, as the company has established commercial operations in Europe and look forwards to launching the product in major European markets over the coming months, noted Jeffrey Buchalter, the group’s president and chief executive officer.
PecFent has also been filed with regulators across the Atlantic, and Archimedes said it is in the process of setting up shop in the US too so that it can market the drug itself once clearance is given by the Food and Drug Administration.