Inflexxion, Inc. Offers Analysis of FDA Advisory Committee Meeting on Prescription Opioid Post-Marketing Studies
Inflexxion, Inc. Offers Analysis of FDA Advisory Committee Meeting on Prescription Opioid Post-Marketing Studies
Newton, MA (PRWEB) December 6, 2010
Inflexxion, the leader in creating scientifically validated solutions for critical areas of health care, sent research scientists to participate in the FDA’s “Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee” on October 21 and 22 in Washington, DC, to highlight prescription drug abuse data captured within tools including Inflexxion’s proprietary NAVIPPRO® data streams. NAVIPPRO provides timely and accurate information about the misuse and abuse of prescription opioids and stimulants nationwide.
During the October FDA meeting, Purdue Pharma LP and King Pharmaceuticals Inc. each presented a series of post-marketing studies examining different data streams in support of their new opioid medications they believe to be tamper-resistant or abuse-deterrent.
“The main conclusion that can be drawn from the meeting is that any company seeking an ‘abuse-deterrent’ or ‘tamper-resistant’ label is going to be required to have a series of epidemiological studies in place and collect data to support their contentions,” said Simon Budman, PhD, founder and CEO of Inflexxion and co-founder of NAVIPPRO. “The FDA, sponsors and the advisory committee seemed to come to an understanding at this meeting about the value of internet monitoring and proprietary data. NAVIPPRO offers a system for collecting data that the government simply doesn’t have.”
For a more detailed summary of the October FDA meeting, please visit the NAVIPPRO website.
About NAVIPPRO
NAVIPPRO (National Addictions Vigilance Intervention and Prevention Program) is a proprietary turnkey solution developed with support from the National Institutes of Health (NIH) and industry that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs. A list of peer-reviewed publications is available at http://www.navippro.com, where you can also sign up to receive the NAVIPPRO Signal e-newsletter.
About Inflexxion, Inc.
Founded in 1989, Inflexxion leverages technology to improve public health. We create clinically validated tools and programs for critical areas of health care, including prevention and wellness education, addiction and pain treatment, and pharmaceutical risk management. Key offerings include: NAVIPPRO, PainEDU.org, painACTION.com, SOAPP, and COMM. These innovative solutions help reduce health-related risks, enhance clinical outcomes, and positively impact the quality of care.
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