Fentanyl Sublingual Spray demonstrates unprecedented, statistically significant pain relief at five minutes post-dose using electronic patient diary data
PITTSBURGH, PA (Vocus) March 31, 2010 -- invivodata, inc., the industry leader in patient reported outcomes (PRO) solutions and services for global clinical research, today 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. We feel strongly that without DiaryPRO we could not have effectively captured the critical data needed to demonstrate Fentanyl SL Spray's effectiveness at relieving pain in the 5-minute post-dose timeframe."
“It’s exciting to apply our experience in collecting reliable, real-time PRO data to help INSYS determine the effectiveness of Fentanyl SL Spray,” said Doug Engfer, president and CEO of invivodata. “We are pleased to have contributed to their research efforts and look forward to forming a long-term relationship with the company as it continues to address the significant unmet medical needs of patients with breakthrough cancer pain.”
About invivodata inc.
invivodata combines behavioral science, information technology, and clinical research expertise to capture high quality clinical trial data directly from patients. invivodata’s electronic Patient Reported Outcomes (ePRO) solutions, which are based on over 20 years of research, deliver reliable patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague paper-based self-report data. invivodata’s solutions include comprehensive trial-support services that facilitate the collection of ePRO data, web-based access to study data and operational reports that give researchers and sponsors visibility into study progress, and scientific and regulatory consulting on the use of PRO data in a regulated
environment. invivodata’s solution has been used in more than 275 clinical programs and is the industry-leading ePRO system in delivering primary efficacy data for FDA drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, Pa., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, Calif., USA. For more information visit www.invivodata.com">www.invivodata.com.
Read the full story at http://www.prweb.com/releases/2010/03/prweb3814064.htm.
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