invivodata, inc. announced that its DiaryPRO® field-based ePRO solution captured primary efficacy data in INSYS Therapeutics' recently completed Phase III trial of Fentanyl Sublingual Spray (SL Spray) to treat breakthrough cancer pain.
During the INSYS pivotal trial, over 100 study participants used DiaryPRO multiple times each day to record responses to questions about the frequency and intensity of pain, usage of study- and supplemental-pain medication, and onset of pain relief following medication. In order to capture onset of pain relief, invivodata designed an eDiary solution that prompted patients to complete an assessment of their pain at several post-dose intervals.
In a statement recently issued by INSYS, the company commented that the drug is the first product to ever show statistically significant pain relief when measuring the summary of pain intensity difference at five minutes in a phase III breakthrough cancer pain trial using Fentanyl.
"We are delighted with the findings of this trial and the results delivered by invivodata's eDiary system," said Neha Parikh, director of clinical operations at INSYS. "It is vital to develop products that provide patients with the fastest relief possible, considering the onset of breakthrough cancer pain is rapid, and often peaks in the first 3-5 minutes."