Archimedes Pharma has got the marketing authorisation on the basis of the results from its three Phase 3 trials including an active comparator study and a large long-term safety and acceptability study.
EC said that PecFent acted as a pain reliever, demonstrated onset of pain relief as early as five minutes and offered clinically meaningful pain relief within 10 minutes in Phase III clinical trials.
Archimedes Pharma president and CEO Jeffrey Buchalter said that 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,” Buchalter said.
