Archimedes Pharma Presents Positive Efficacy and Safety Data on Nasalfent
Archimedes Pharma Ltd presented new clinical data from a Phase II study of Nasalfent(r), an fentanyl citrate nasal spray aimed at providing a fast, effective and convenient treatment for breakthrough cancer pain. Data were presented at the 10th Congress of the European Association for Palliative Care (EAPC) in Budapest showing that Nasalfent can give significant, clinically meaningful levels of pain relief and a reduction in pain intensity within 5 minutes of dosing.
The open-label, multi-centre study, was conducted in two parts - the first to establish an effective dose for each patient, followed by an efficacy phase in which the dose identified in part one was evaluated using a series of measures for pain relief. Statistically significant improvements from baseline in pain intensity and onset of pain relief were seen within five minutes of dosing (both p<0.05) in the 15 patients included in the efficacy analysis. All patients experienced at least one episode with meaningful pain relief and in the 55 breakthrough cancer pain episodes assessed, some degree of pain relief was recorded in 96% and clinically meaningful pain relief in 73%.
All doses of Nasalfent from 25mcg to 800mcg were well-tolerated, with no significant nasal findings or symptoms of irritation seen at any dose. In a patient satisfaction survey, 77% rated the product as 'good', 'very good' or 'excellent'.
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