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