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A new nasal spray to treat breakthrough cancer pain has achieved its primary efficacy endpoint in a pivotal phase III clinical trial, pharmaceutical firm Archimedes Pharma has reported.
NasalFent, the company’s fentanyl citrate nasal spray, showed a greater reduction in pain in patients with breakthrough cancer pain.
Such pain affects up to 95% of all cancer patients and is rapid in onset, often reaching maximum intensity within five minutes and lasting between 30 minutes and an hour.
NasalFent showed a highly-statistically significant improvement in summary of pain intensity difference at 30 minutes (SPID30) compared with placebo.
Patients also reported statistically-significant differences in pain scores with NasalFent compared to placebo within five minutes of dosing. Archimedes Pharma said that NasalFent is the first product to have demonstrated, in a robust large scale phase III programme, onset of pain relief as early as five minutes.
The improvement in pain was maintained for 60 minutes after dosing with statistically-significant results at all measured time points.
Richard de Souza, chief executive of Archimedes, said: “We are pleased with the study results which position NasalFent, the first real intranasal form of fentanyl, as a product that redefines the standard of care for patients suffering with breakthrough cancer pain.”
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