Archimedes Pharma, a UK-based specialty drug company, has presented positive data from the 043 study of NasalFent, its fentanyl citrate nasal spray for the rapid relief of breakthrough cancer pain, at the American Pain Society meeting in San Diego, California.
Results covering both primary and secondary outcomes showed statistical superiority for NasalFent over placebo and suggest that the drug is the first product to demonstrate both rapid onset of pain relief within five minutes and early, clinically-meaningful pain relief within 10 minutes of dosing. Use of rescue medication was low, confirming that NasalFent was also consistently effective.
The firm has also reported positive headline Phase III results showing NasalFent achieved the primary endpoint in the double-blind, placebo-controlled 044 trial. Patients showed a statistically-significant improvement in Pain Intensity Difference within 15 minutes compared to immediate-release morphine sulphate (p<0.04) that was maintained for 60 minutes after dosing.
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