The mission of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the United States Food and Drug Administration (FDA) is to identify, prioritize, sponsor, coordinate, and promote innovative activities — with a special interest in optimizing clinical trials — that will expedite the discovery and development of improved analgesic, anesthetic, and addiction treatments for the benefit of the public health.
ACTTION is a multi-year, multi-phase initiative that is closely aligned with the FDA's Critical Path Initiative. This public-private partnership has been designed to streamline the discovery and development process for new analgesic, anesthetic, and addiction medications and to more generally accelerate the development of treatments with improved efficacy and safety.
The key objectives of ACTTION involve initiating and supporting strategic collaborations among a broad spectrum of stakeholders — including, but not limited to, academia, the FDA and other government agencies, industry, professional organizations, patient advocacy groups, foundations, and philanthropic organizations — with the goals of sharing data and innovative thinking about the development of novel therapeutics. These strategic collaborations involve a wide range of research projects and other activities, for example, scientific workshops, consensus meetings, and in-depth analyses of clinical trial data to determine the effects of research methods on study assay sensitivity and efficiency.
ACTTION is intended to have benefits that are international in scope. To represent the bridges that ACTTION is establishing among its diverse stakeholders, this website is illustrated with watermarks of two bridges that share the distinction of connecting different continents. Directly below is the First Bosphorus Bridge in Istanbul, Turkey, which connects Europe and Asia; on the Contact Us webpage is the Leifur Eiriksson Bridge in Iceland's Reykjanes peninsula, which spans a rift valley between the North American and European continental plates.
November 26, 2013: American Pain Society Letter to FDA Commissioner Hamburg About IMMPACT and ACTTION
The President of the American Pain Society (APS), Roger Fillingim, PhD, has sent a letter on behalf of the APS Board of Directors to Commissioner Margaret Hamburg of the FDA. The letter expresses the society’s appreciation for the FDA’s support of IMMPACT and ACTTION, and emphasizes that "This type of initiative is critical for advancement of therapies to treat persistent pain conditions that afflict millions of Americans." The complete letter is available here.
November 4, 2013: 3rd ACTTION Scientific Workshop to be held June 23-24, 2014, at the FDA White Oak campus, Silver Spring, Maryland
The 3rd ACTTION Scientific Workshop will be held June 23-24, 2014, at the FDA White Oak campus in Silver Spring, Maryland. The workshop will focus on translational pain research and will be co-chaired by Allan Basbaum, PhD, Robert Dworkin, PhD, Frank Porreca, PhD, and Dennis Turk, PhD. Presentations and panel discussions will review and discuss preclinical and clinical studies of genetic, epigenetic, and pharmacogenomic aspects of pain and related behaviors; transformative approaches to identifying analgesic treatments, including stem cells, gene therapy, and toxins; and recent translational analgesic success stories. A complete agenda and registration information will be available on the ACTTION website by early 2014.
October 23, 2013: Two Commentaries About ACTTION Articles Published in November 2013 Issue of Pain
The November issue of Pain (2013, volume 154, issue 11) contains two commentaries about ACTTION articles published in the same issue. In "The IMMPACT factor or IMMPACT strikes again!," Stephen Butler, MD, discusses IMMPACT recommendations for abuse liability measures to be used in analgesic clinical trials in patients with pain. The commentary begins "'Not another article from IMMPACT!' may be your first reaction when glancing at the Table of Contents in this month’s issue of Pain. The IMMPACT group continues to supply a tremendous amount of valuable information on the proper design of drug studies. This has been constructive in the dialogue between the pharmaceutical industry and licensing bodies involved in controlling market access for new compounds for pain. IMMPACT recommendations are also important for any group performing drug studies because they represent the established norms and opinions of experts across industry, academe, and the FDA. They are also useful guides to help critical reading of such studies, especially when study design problems can affect intelligent interpretation of results."
In a second commentary, Mark Sullivan, MD, discusses ACTTION recommendations for the classification and definition of misuse, abuse, and related events in clinical trials. The commentary notes that after reviewing existing definitions of misuse, abuse, and related events and finding that terms were often defined inconsistently or idiosyncratically, ACTTION developed "definitions for use in analgesic clinical trials, post-marketing adverse event monitoring, and, hopefully, clinical care. This is an important attempt at standardizing terminology around opioid misuse and abuse that should greatly aid communication and comparison across studies."