invivodata provides support to supplement approval of AMITIZA for irritable bowel syndrome with constipation in the United States.
Pittsburgh, PA-May 12, 2008-invivodata (www.invivodata.com), the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced that its ePRO solutions-DiaryPRO® and SitePRO®-captured primary efficacy data that supported the recent U.S. Food and Drug Administration’s (FDA) supplemental approval of Sucampo Pharmaceutical's AMITIZA® (lubiprostone) 8 mcg twice daily for the treatment of irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older.
invivodata designed and implemented a combination of site-based and field-based ePRO data capture systems to collect critical efficacy data for Sucampo’s Phase 2 and Phase 3 trials of AMITIZA® for IBS-C treatment. Throughout the trials, investigative site personnel used SitePRO, invivodata’s in-clinic solution, to determine subject eligibility. Trial subjects then used DiaryPRO, invivodata’s field-based ePRO system, to record daily assessments plus SitePRO to record weekly in-clinic assessments of disease severity and symptom relief. Throughout the trials, data collected from both systems were integrated and easily accessible to study staff on invivodata’s comprehensive ePRO management system.
“We are very pleased with invivodata’s contributions to this program and their ability to accurately capture the critical data we needed to support FDA supplemental approval of AMITIZA,” said Dr. Gayle Dolecek, senior vice president of research & development at Sucampo Pharmaceuticals. “Their staff was very knowledgeable about the scientific and practical aspects of PRO data collection, and their processes were found to be regulatory compliant during an FDA audit of their systems and practices, which was an important component of this approval.”
“Sucampo should be applauded for its work on the further development of AMITIZA and its desire to fully understand the impact of IBS-C among this patient population,” said Dr. Jean Paty, vice president of scientific, quality, and regulatory affairs at invivodata. “We are happy to celebrate the supplemental approval of AMITIZA and to add Sucampo to our long list of customers whose successful new drug approvals included primary endpoint data collected with our ePRO systems.”