Inflexxion Data Analysis Services (National Addictions Vigilance Intervention and Prevention Program: NAVIPPRO) work to better understand prescription opioid and stimulant use/abuse and the effectiveness of abuse-deterrent formulations (ADF).

NAVIPPRO offers surveillance, risk management, and epidemiological studies required for FDA-regulated products that have abuse liability and pose potential health risks (both pharmaceutical and tobacco/nicotine products).

The NAVIPPRO Mosaic: Research and Consulting Services

Postmarket Required Studies and Surveillance

Real-time monitoring of prescription drug use and abuse with sentinel, high-risk populations ensure state-of-the-art pharmacovigilance and rapid detection of unanticipated outcomes

  • Supports FDA postmarket requirements for epidemiological studies through protocol and statistical analysis plan development, interim study reports, and final study report
  • Supports FDA postmarket surveillance requirements through regular monitoring and reporting including baseline reports, ongoing quarterly briefs, and annual submission reports
  • Sourced by data from Inflexxion’s proprietary data streams
    • ASI-MV/BHI-MV
    • CHAT
    • Web Information Services
    • Custom Studies

 

 

REMS Assessment

All Risk Evaluation and Mitigation Strategies (REMS) must include an approach to assessing the effectiveness of their safety measures. Assessment results may be used to modify or even eliminate a REMS.

We work with our clients to develop strategies to conduct the most appropriate assessments for both patients and providers. These may include knowledge assessments to evaluate the effectiveness of the REMS activities in informing patients and providers about safe use or conducting drug utilization studies to evaluate appropriate prescribing.

Customized solutions ensure the most valuable assessments for your product.

Custom Scientific and Epidemiological Studies

  • We work closely with clients to tailor exploratory or hypothesis-driven epidemiological studies, which include:
    • Understanding current trends to inform pre-market activities and supplement New Drug Applications
    • Evaluation of effectiveness of abuse deterrent formulations (ADFs) using the mosaic approach
    • Tracking or comparing prescription drug abuse trends from different populations of interest
    • Understanding behavior associated with prescription drug abuse and misuse, such as route of administration and source of drug acquisition
    • Exploring and provoking online discussion of experience with specific pharmaceutical products, including reasons for use and methods of tampering to defeat abuse deterrent properties
    • Evaluating patient and provider reactions to the introduction of new drug products, removal of old drug products, and other market changes
    • Assessing the impact of substance abuse and chronic pain treatment protocols on patient populations locally, regionally, and nationally

Publication Strategy

We work with clients to identify the best strategy for data dissemination of key findings to support scientific, regulatory, and business objectives.  In partnership with our clients, we design and implement studies, articulate key messages, and develop a strategic plan that begins with submission of abstracts for poster and oral presentations at carefully selected conferences and culminates with manuscript submission to peer-reviewed journals most likely to reach target audiences.

  • More than 80 publications in peer reviewed journals in the past 10 years
  • More than 10 books or book chapters published
  • Over 100 presentations at professional meetings
  • Multiple presentations to the FDA and at Ad Comms