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
  • In collaboration with PinneyAssociates, NMS Labs provides a team of regulatory and scientific experts that understand FDA’s expectations of abuse-deterrent drugs and formulations, and other drugs that act on the central nervous system, and offer full service advisory and in vitro testing capabilities in these areas.

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