Inflexxion, Inc. Awarded FDA Contract to Assist in Evaluation of Opioid-Related Drug Risks
Inflexxion to provide analysis to the FDA from its surveillance data system on prescription drug abuse
NEWTON, MA (October 17, 2016) – The US Food and Drug Administration (FDA) has awarded Inflexxion, Inc. a five-year, $10 million IDIQ contract. The contract addresses, in part, the FDA’s objectives to obtain post-marketing prescription and OTC drug abuse surveillance data summary reports, and analytical data sets generated from aggregate data from individuals entering or being assessed for substance abuse treatment.
Inflexxion collects real-time data, the largest of its kind, and is the only such system to collect patient data at the point-of-care. With approximately 700,000 records, it continues to expand with over 70,000 new records annually. Inflexxion’s research staff bring to this field over 20 years of scientific analysis, expertise, and reporting through customized research, peer reviewed publications and expert testimony.
According to the American Society of Addiction Medicine, drug overdose is the leading cause of accidental death in the U.S., with 47,055 lethal drug overdoses in 2014. Opioid addiction is driving this epidemic, with 18,893 overdose deaths related to prescription pain relievers.
“We are delighted to work with the FDA in support of its efforts to combat the current opioid epidemic,” said Simon Budman, Founder of Inflexxion and a leading expert in opioid use and abuse. “We look forward to being able to provide our preeminent data to the FDA to effectively monitor the impacts of this public health crisis and address it through empirically-informed measures.”
Inflexxion will be providing data to the FDA from its surveillance data resource on prescription drug abuse, the Addiction Severity Index Multimedia Version (ASI-MV). The system collects data from individuals entering substance abuse treatment or being assessed for substance abuse disorders. The ASI-MV is used in more than 500 treatment centers around the country and provides critical data to pharmaceutical companies in the area of prescription opioids, stimulants, and other medications used in ways other than that prescribed.
Inflexxion helps healthcare organizations, provider communities, pharmaceutical companies, and regulatory authorities to improve patient care and inform public policy. Through their strategic approach and depth of expertise, Inflexxion analyzes and disseminates health-related data for surveillance, risk management, epidemiological studies, quality improvement, and outcome measurement. Inflexxion’s unique data collection includes multiple data streams at the point-of-care, Internet Monitoring technology, and web-surveys with hard to reach populations. For more information visit www.inflexxion.com.
Contact: Jeannette Pforr