Navigation Links
invivodata Delivers Critical Symptom Relief Data in INSYS Therapeutics' Breakthrough Cancer Pain Trial

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">


Read the full story at

Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related biology technology :

1. invivodata Offers Complimentary PRO Gap Analysis
2. INC Research and invivodata Announce ePRO Partnership
3. invivodata Opens Registration for 3rd Annual Patient Reported Outcomes Conference
4. Quintiles Selects invivodata as Primary Partner for ePRO Solutions; Collaboration to Enhance Value, Effectiveness and Speed in Drug Development
5. invivodata Announces ePROficiency 2009 Web Seminar Series
6. invivodata and PRO Consulting to Present at International Industry Events
7. ECBC Delivers Mobile Labs to DRDC, Celebrates with Ribbon Cutting Ceremony
8. Intelligent Design Book Delivers Blow to Darwin
9. Shire plc: Core Portfolio of Products Delivers 20% Sales Growth
10. Sparta Systems TrackWise(R) Solution Delivers Workforce Training and Learning Initiatives for Cangene Corporation
11. Zvetco Biometrics Delivers a Cohesive Security System Integrating Fingerprint Biometrics with Sun Identity Management Solutions.
Post Your Comments:
Related Image:
invivodata Delivers Critical Symptom Relief Data in INSYS Therapeutics' Breakthrough Cancer Pain Trial
(Date:11/26/2015)... , England , November 26, 2015 /PRNewswire/ ... Medical, an innovative medical device company specializing in imaging technologies, ... from the European Commission as part of the Horizon 2020 ... company to carry out a large-scale clinical trial in breast ...      (Logo: , --> ...
(Date:11/25/2015)... 25, 2015  PharmAthene, Inc. (NYSE MKT: PIP) announced ... stockholder rights plan (Rights Plan) in an effort to ... (NOLs) under Section 382 of the Internal Revenue Code ... PharmAthene,s use of its NOLs could be substantially limited ... in Section 382 of the Code. In general, an ...
(Date:11/25/2015)... 25, 2015 Studies reveal the ... plaque and pave the way for more effective treatment for ...     --> --> ... health problems in cats, yet relatively little was understood about ... studies have been conducted by researchers from the WALTHAM Centre ...
(Date:11/25/2015)... , Nov. 25, 2015  Neurocrine Biosciences, Inc. ... Gorman , President and CEO of Neurocrine Biosciences, will ... Conference in New York . ... visit the website approximately 5 minutes prior to the ... replay of the presentation will be available on the ...
Breaking Biology Technology:
(Date:10/29/2015)... 29, 2015 NXTD ) ... focused on the growing mobile commerce market and ... StackCommerce, a leading marketplace to discover and buy ... smart wallet on StackSocial for this holiday season. ... the "Company"), a biometric authentication company focused on ...
(Date:10/27/2015)... 2015 Munich, Germany ... technology (ASGM) automatically maps data from mobile eye tracking ... , so that they can be quantitatively analyzed with ... Munich, Germany , October 28-29, 2015. SMI,s Automated ... mobile eye tracking videos created with SMI,s Eye ...
(Date:10/26/2015)... LAS VEGAS , Oct. 26, 2015 ... in modern authentication and a founding member of the ... its latest version of the Nok Nok™ S3 Authentication ... standards-based authentication that supports existing and emerging methods of ... ideal for organizations deploying customer-facing applications that require Internet ...
Breaking Biology News(10 mins):