Archimedes Pharma reports positive results from Phase III cancer pain trial

Archimedes Pharma, a UK-based specialty pharmaceutical company, has reported new positive headline Phase III results for NasalFent, the company’s differentiated fentanyl citrate nasal spray, developed for the rapid relief of breakthrough cancer pain.

The Phase III study compared NasalFent to immediate release morphine sulphate, the most commonly prescribed medicine for breakthrough cancer pain.

According to Archimedes Pharma, NasalFent met the primary efficacy endpoint in the Phase III study 044. Patients treated with NasalFent showed a statistically significant improvement in pain intensity difference within 15 minutes (PID15) compared to immediate release morphine sulphate (p < 0.04), meaning a greater reduction in pain.

NasalFent is said to be the only one of the new generation of fentanyl products to have demonstrated statistically significant improvements over immediate release morphine sulphate. Significantly better improvements in pain scores for NasalFent versus immediate release morphine sulphate were seen at all subsequent time points indicating that superiority of NasalFent was maintained for 60 minutes after dosing, said Archimedes.

NasalFent has showed both consistent effectiveness and high acceptability; 94% of patients completed the double-blind part of the study and 70% of patients elected to continue therapy with NasalFent in the long term Phase III safety study, the company added.

Richard Souza, CEO of Archimedes, said: These data clearly show that NasalFent is superior to the benchmark product for this condition and fully supports the results from study 043 which demonstrate that NasalFent offers pain relief within five minutes of dosing and is highly acceptable to patients. Data from our third Phase III study, 045, a long-term safety study, including over 500 patients, will be available shortly.