NAVIPPRO Research & Custom Analytics
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).
Real-time monitoring of pat
terns and trends of use and abuse ensure state-of-the-art pharmacovigilance. Near real-time data with sentinel, high-risk populations are used to monitor abuse-deterrent prescription medications and ensure rapid detection of unantici
pated outcomes. Regular monitoring and reporting supports FDA post-market surveillance requirements, including:
- Baseline reports
- Ongoing quarterly briefs
- Annual submission reports
Custom Scientific and Epidemiological Studies
Inflexxion designs studies that support new drug applications (NDAs) and pre-approval advisory committee preparation to post-marketing epidemiology studies. This study data includes evaluation of abuse-deterrent formulations and assists in tracking abuse trends of specific illicit and prescription drugs. Additionally we:
- Support ADF labeling and provide a better understanding of the abuse deterrent qualities of a given formulation
- Assist public health stakeholders in tracking abuse trends of illicit and prescription drugs and exploring online discussion of specific pharmaceutical products
- Evaluate reactions to the introduction of reformulated drugs and identify methods aimed to defeat the abuse deterrent properties