To address the nationwide increase in abuse of prescription drugs, particularly opioids, Inflexxion® can help pharmaceutical and biotechnology companies to develop REMS for their products.
With the expertise needed to help pharmaceutical companies develop REMS, Inflexxion is one of the few companies that provides all the essential elements of an effective REMS, from surveillance through signal detection, field investigation and intervention and prevention.
Our scientific team consists of expert in the areas of pain, opioids, stimulants and risk management, and includes individuals with significant FDA experience. We also collaborate with external thought leaders in areas of pain management, ADHD specialists, as well as patient advocacy groups, clinician organizations and law enforcement experts who monitor and investigate prescription opioid and stimulant abuse activities. Our REMS are the product of in-depth experience and ready for real-world application in working with the FDA on actual risk management issues.
More Details
- Our REMS may incorporate the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO™) for surveillance along with intervention/prevention programs such as PainEDU.org®, painACTION.com® and MyStudentBody®.
- Our plans demonstrate to the FDA that our REMS include strategies for preventing abuse, addressing abuse if it is present, and monitoring the drug post-launch.
- Our offerings are scientifically tested and validated with assistance from the National Institutes of Health.