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.  NMS Labs has the experience and knowledge of current FDA Guidance on Abuse-Deterrence to design and conduct the highest quality Risk Evaluation and Mitigation Strategy (REMS) study and provide a report that is FDA-ready - 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
  • ADF play a crucial role in combating prescription drug abuse epidemic
  • ADF studies are critical for NDA filings & may help obtain FDA fast track
  • Commonly studied drug formulations include:
    • Opioid-based products
    • Cannabinoid-based substances
    • Amphetamine & stimulant-based products
    • Benzodiazepines
    • Extended & immediate release formulations
    • Transdermal devices
    • Over-the-counter (OTC) products
    • Pseudoephedrine to Methamphetamine conversion
    • Generics

Other Testing

  • In-vitro testing / "Dissolution Analysis"
  • Formula characterization
  • Testing method development

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 and success in Abuse Deterrent Formulation Testing, with a track record of conducting ADF studies well before the FDA guidance on Abuse-Deterrent Opioids - Evaluation and Labeling
  • Highly-trained team, including former DEA experts
  • Proven, consultative approach based on consistent results and clear communication -> effective partnerships

Learn More

Call us or email NMS Labs today to talk about your specific needs.

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