Conducting High-Quality Studies with FDA-Ready Reports

The development of a new drug or therapy is a high-risk venture. Any setbacks with the FDA can be costly and time-consuming to correct. This is especially true for Category I compounds with high abuse potential. But NMS Labs is different. Experience and knowledge of current FDA Guidance on Abuse-Deterrence enables us to design and conduct the highest quality Risk Evaluation and Mitigation Strategy (REMS) study that enable us to provide a report that is FDA-ready and from a trusted and unbiased third-party source.

Why Abuse Deterrence Matters

  • Opioid abuse is at an all-time high and a worldwide challenge without an end in sight
  • ADFs (Abuse Deterrent Formulations) play a crucial role in combating prescription drug abuse epidemic
  • ADF studies are critical for NDA filings and may help obtain FDA fast track
  • Commonly studied drug formulations include:
    • Opioid-based products
    • Cannabinoid-based substances
    • Pseudoephedrine to methamphetamine conversion
    • Amphetamine and stimulant-based products
    • Extended-release and immediate-release formulations
    • Transdermal devices
    • Over-the-counter (OTC) products
    • Generics

Other Testing

  • Opioid-based products
  • Cannabinoid-based substances
  • Pseudoephedrine to methamphetamine conversion
  • Amphetamine and stimulant-based products
  • Extended-release and immediate-release formulations
  • Transdermal devices
  • Over-the-counter (OTC) products
  • Generics

Replicating Real-Life Abuse Techniques

We perform a wide range of “kitchen-type” experiments to challenge drug delivery devices to their limits and compare to currently available formulations. We then take the outcomes and quantitate by LC-MS/MS to measure, evaluate, and report detailed and scientifically backed conclusions.

The NMS Advantage

  • Extensive experience with successful Abuse Deterrent Formulation Testing dating back to the very beginning of the opioid crisis. We have a proven track record of conducting ADF studies leading up to the FDA guidance on Abuse-Deterrent Opioids - Evaluation and Labeling
  • Highly-trained team of experts with real-world knowledge of Abuse Chemistry that have helped to establish current methodologies and standards for ADF testing
  • Proven, consultative approach based on reliable results and clear communication results in effective partnership

Learn More
Call us or email: ADFTesting@nmslabs.com today to talk about your specific needs.
To learn more contact us at 1-866-522-2206 / CSTIQ@nmslabs.com