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June 25, 2018

Analgesic Solutions Pain Research Methodology Applicable Across Therapeutic Spectrum

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Keynote Speaker at Drug Information Association Meeting Emphasizes the Need for Better Pain Research

WAYLAND, Mass., June 25, 2018 /PRNewswire/ — Nora Volkow, MD, Director, National Institute on Drug Abuse (NIDA), National Institutes for Health (NIH), opened the 2018 Drug Information Association (DIA) Meeting in Boston with the Keynote Address emphasizing the need for new approaches for treating pain. As an industry leader in the design and execution of pain clinical trials, Analgesic Solutions, LLC’s participation in this years’ DIA Meeting will highlight the Company’s offerings across an ever-expanding roster of clinical research target indications.

The Company’s flagship product, the Quantitative Data Surveillance System (QDSS™) central statistical surveillance system, assists sponsors in improving the outcome of clinical trials across a variety of clinical indications with a focus on helping meet regulatory guidance for implementing Risk-Based Monitoring. Combined with the Company’s proprietary validated training programs and a range of tools for mitigating risk in clinical trials, Analgesic Solutions’ impact on the pain research space is now gaining traction in the broader clinical research arena.

“Analgesic Solutions applauds the DIA for its recognition of the need for better pain research. As leaders in helping sponsor companies bring their innovative products to market in this space, we are proud of the impact we have had in delivering better alternatives to people suffering with chronic pain,” commented Nathaniel Katz, MD, MS, Founder and Chief Executive Officer of Analgesic Solutions. “It is particularly gratifying to see clients engage us along similar lines outside of the pain arena. Of note is the Company’s Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®), which is the only system acknowledged to fulfill the requirement of the Food and Drug Administration’s (FDA) Abuse Potential guidance to systematically collect data on potentially abuse-related events in all clinical trials of central nervous system (CNS) acting drugs, and our Placebo Response Reduction training system, both of which are highlighted at this week’s conference.”


Analgesic Solutions, LLC., founded in 2006, is a privately held company that reduces
the risks in clinical trials through consulting, innovative tools and technology. With
hundreds of projects completed and ongoing collaborations with regulatory authorities,
Analgesic Solutions is the premier choice for mitigating risk associated with
measurement error in clinical trials.


QDSS is a statistics and predictive analytics-driven, central surveillance system that
maximizes assay sensitivity – the ability to differentiate placebo from drug. QDSS
combines SPC (Statistical Process Control) and other methods with interpretation of
analyses by a team of clinical trial experts. The resulting data and analyses are
provided in easy to use reports and interactive visualizations to sponsors and Clinical
Research Organizations (CROs). These methods are used to quantify aberrancy and
provide actionable interventions during the conduct of clinical trials.


MADDERS is the first and only standardized system for prospectively classifying and
quantifying abuse-related events in clinical trials of central nervous system (CNS) active
drugs, in accordance with FDA’s 2017 guidance on Assessment of Abuse Potential of
Drugs. MADDERS was designed to fill an unmet need in meeting regulatory
requirements for assessing abuse potential during clinical development. MADDERS
was developed based on recommendations of the Analgesic, Anesthetic, and Addiction
Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) publicprivate
partnership, an FDA initiative. MADDERS has been successfully implemented
in multiple Phase 2 through Phase 4 clinical trials involving adult and pediatric patients,
testing analgesic and non-analgesic CNS-active medications. Results to date have
proven the system to be an invaluable asset in assisting sponsors with their required
drug abuse potential assessment.


The subjects’ expectation of treatment is the major driver of the placebo response.
Several studies have shown that intentional “neutralization” of subject expectation can
reduce the placebo response. Analgesic Solutions has created a training program to
reduce placebo response and improve discrimination between active treatment and
placebo through a change in behavior. With over 30,000 subjects and study staff
already trained, Analgesic Solutions is the industry leader in delivering evidence based,
validated training solutions.

Analgesic Solutions, LLC, founded in 2006, is a privately held company focused on increasing assay sensitivity in the conduct of pain clinical trials through consulting, innovative tools and technology, and training. Our team, with Nathaniel Katz M.D., M.S., serving as our foremost expert, helps clients develop and commercialize better treatments for pain. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the expert at identifying and mitigating the random and systematic errors that lead to negative clinical trials.

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