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 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
- Per CDC data, opioids responsible for 33,000+ deaths in
the U.S. in 2015
- ADF play a crucial role in combating prescription drug
- 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
- Extended & immediate release formulations
- Transdermal devices
- Over-the-counter (OTC) products
- Pseudoephedrine to Methamphetamine conversion
Replicating Diversion 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
- 12+ years of experience and success in Abuse Deterrent Formulation Testing
- Highly-trained team, including former DEA experts
- Proven, consultative approach based on consistent results and clear communication -> effective partnerships
More information can be found here.
Call us or email NMS Labs today to talk about your specific needs.
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