FDA Funds Study of Therapies for Pain, Addiction, Sedation
A team led by Robert H. Dworkin, Ph.D., professor in the department of Anesthesiology has been awarded five years of funding from the FDA for up to $4 million to speed the discovery and development of analgesic, anesthetic, addiction and peripheral neuropathy treatments for patients. The award continues the work of the ACTTION public-private partnership, which was initiated by the FDA, Dworkin and Dennis Turk, Ph.D., from the University of Washington in 2010.
ACTTION, which stands for Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, studies different approaches to improve the methods used to evaluate and approve safe and effective treatments for patients who have few or no options. The work is greatly needed: in the last decade, very few truly new therapies have been approved by the FDA for acute or chronic pain. In addition, individuals with diabetic peripheral neuropathy or chemotherapy-induced peripheral neuropathy have no disease-modifying treatment options. The few existing treatments in addiction medicine lack strong safety and efficacy profiles, and though adequate sedation approaches exist, many are old and companies are unsure of the best way to test new methods.
The ACTTION team’s focus will be the assessment of outcome measures and clinical trial designs. One major undertaking is making the pain scale, which patients use to rate their pain from 0 to 10, more “user friendly” so that patients’ responses more accurately and consistently reflect their pain experience. An improved pain scale will allow researchers to better gauge the efficacy of new treatments. Another is defining “success” in clinical trials of treatments for stimulant addiction: is a therapy considered successful if a patient addicted to cocaine becomes abstinent, or reduces cocaine use by 50 percent? These and many other questions will be addressed through extensive data review, carefully designed studies and consensus meetings.
ACTTION involves the collaboration of public and private organizations, including professional societies, patient advocacy groups, industry and government. The group recently published its sixtieth journal article. In addition to Dworkin, Denham S. Ward, M.D., Ph.D., professor emeritus and past chair of the Department of Anesthesiology and Jennifer Gewandter, Ph.D. and Shannon Smith, Ph.D., both assistant professors of Anesthesiology, participate in ACTTION.
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Emily Boynton |