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June 11, 2018

Analgesic Solutions Presents Data from the Implementation of its Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®)

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Company Establishes Scientific Advisory Board for the MADDERS

WAYLAND, Mass., June 11, 2018 /PRNewswire/ — Analgesic Solutions, LLC announced today that Dr. Ryan Lanier will be presenting results from the implementation of the company’s proprietary Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS) at the ongoing College on Problems of Drug Dependence 80th Annual Scientific Meeting in San Diego. MADDERS was utilized to assess potentially abuse-related events in Nektar Therapeutic’s SUMMIT-07 Phase 3 clinical trial of its opioid agonist NKTR-181 for treating chronic low back pain in opioid naïve subjects. A New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) that includes the MADDERS data.

The Company also announced today the formation of a Scientific Advisory Board (SAB) for the MADDERS. The MADDERS SAB will ensure the ongoing development of MADDERS is aligned with the scientific and regulatory needs of both sponsors and regulatory authorities such as the FDA and DEA for the assessment of abuse potential of drugs in clinical development.

The MADDERS SAB is comprised of experts in the fields of drug abuse research, controlled substance regulation, clinical drug development, public health and societal impacts of drug abuse, and industry needs. Current members of the MADDERS SAB include Jack E. Henningfield, PhD, Michael Klein, PhD, and Eric C. Strain, MD.

Dr. Nathaniel Katz, MD, MS, Founder and Chief Executive Officer of Analgesic Solutions, commented, “The inclusion of data supported by the MADDERS in a NDA and the launch of our SAB are major milestones for the Company. We are delighted that Drs. Henningfield, Klein, and Strain have agreed to join our Scientific Advisory Board to assist us in further developing our unique MADDERS platform. The combined talents of these world class scientists and scholars will be a tremendous asset as we seek to further establish MADDERS as the first validated tool available to sponsors to assist them in meeting their regulatory requirements for prospectively assessing the abuse potential of CNS-active drugs in clinical development.”

College on Problems of Drug Dependence 80th Annual Scientific Meeting (2018), San Diego, CA: Oral Presentation: “Assessment of Drug Abuse-Related Events with MADDERS in SUMMIT-07: A Phase-3 Study of NKTR-181 in Patients with Moderate to Severe Chronic Low-Back Pain”; Abstract #76; Presenter: Ryan Lanier, Ph.D., Analgesic Solutions; Session: The Pain and the Strain Comes Mainly from the Brain; Date: Wednesday, June 13, 2018, 1:30p.m. -1:45p.m. PDT.

Brief Resumes of Current Members of Analgesic Solutions’ MADDERS Scientific Advisory Board:

Jack E. Henningfield is Vice President, Research, Health Policy, and Abuse Liability, at Pinney Associates, and Professor, Adjunct, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine. Prior to joining PinneyAssociates, Dr. Henningfield directed abuse potential assessment at the National Institute on Drug Abuse and contributed to drug scheduling recommendations. At PinneyAssociates he contributes to the abuse potential assessments (8 Factor Analyses), drug scheduling, opioid abuse deterrent formulation assessment and labeling, and risk management. He has published more than 400 articles and books.

Michael Klein is founder and CEO of Controlled Substances Scientific Solutions LLC, where he provides strategic consulting to drug companies that aim to advance controlled substance drug approval through the FDA. Dr. Klein is the former Director of the FDA’s Controlled Substance Staff and served in several leadership roles within the FDA’s Center for Drug Evaluation & Research (CDER). Among his notable recent achievements, Dr. Klein was a principal author of the 2017 FDA Finalized Guidance for Industry on Assessment of Abuse Potential of Drugs.

Eric C. Strain is Director of the Johns Hopkins Center for Substance Abuse Treatment and Research and the Executive Vice Chair for Psychiatry at Johns Hopkins Bayview Medical Center. Dr. Strain maintains an active research program in substance abuse related issues, provides clinical care to patients, teaches medical students and residents, and provides administrative supervision in the maintenance of current substance abuse programs and the development of new substance abuse initiatives at Johns Hopkins.

ABOUT MADDERS

The Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®) is the first and only standardized system for prospectively classifying and quantifying potentially abuse-related events in clinical trials of central nervous system (CNS) active drugs in accordance with the FDA’s 2017 finalized guidance on the Assessment of Abuse Potential of Drugs. MADDERS was designed to meet an unmet need in evaluating abuse potential in clinical trials and is intended to assist sponsors in meeting their regulatory requirements for assessing the abuse potential of drugs in clinical development. The development of MADDERS was based on recommendations for identifying, evaluating, and classifying events set forth by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership, an FDA initiative. MADDERS has been successfully implemented in multiple Phase 2 through Phase 4 multicenter 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, and to assist FDA with scheduling recommendations.

ABOUT ANALGESIC SOLUTIONS

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.


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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