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invivodata inc. announced that DiaryPRO®, its field-based electronic COA Solution captured the primary efficacy data in the pivotal studies that led to INSYS Therapeutics’ successful New Drug Application (NDA) for SUBSYS® fentanyl sublingual spray. INSYS received FDA approval to market SUBSYS for the treatment of breakthrough cancer pain medication last month.
Breakthrough cancer pain is characterized by sudden, often unpredictable, episodes of intense pain which can peak in severity at three to five minutes despite background pain medication. Since INSYS needed to demonstrate the onset of pain relief following medication, they chose an electronic diary (eDiary) to capture this critical patient reported outcome(PRO) data. INSYS selected invivodata’s DiaryPRO for their Phase III clinical trial based on its effectiveness at capturing real-time, patient-centered data and its easy-to-use features which enable patients toeasily record data, even during temporary, and sometimes severe pain flares.
“We had a very good experience working with invivodata and are thrilled with the results they delivered in support of the SUBSYS development program,” said Neha Parikh, Senior Director of Clinical Operations at INSYS. “We feel strongly that without invivodata’s expertise in designing and implementing effective COA data capture solutions, we could not have captured the critical, time-sensitive data we needed to demonstrate the full therapeutic benefit of SUBSYS.”
During 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.