DiaryPRO, invivodata’s 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).
Since Insys needed to demonstrate the onset of pain relief following medication, it chose an electronic diary (eDiary) to capture this critical patient reported outcome (PRO) data. Insys selected invivodata’s DiaryPRO for its phase III clinical trial based on its effectiveness at capturing real-time, patient-centered data and user-friendly features that enable patients to easily 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.”