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U.S. FDA Approves Athena Bioscience’s New Drug Application (NDA) for QDOLO™ (tramadol hydrochloride) Oral Solution

Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved QDOLO™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Full story.

Opioid Patient Protection Recommendations accepted for publication in Mayo Clinic Proceedings

October 1, 2020, CHICAGO, Illinois – A multidisciplinary consensus panel convened by the American Academy of Pain Medicine Foundation has issued new recommendations in Mayo Clinic Proceedings about ensuring patient protections when tapering opioids. The recommendations offer guidance to pain specialists and primary care providers—as well as patients, payors, and regulators—about the intricacies of opioid reduction.

In recent years, prescribers in the United States have made considerable efforts to reduce or discontinue opioids in patients who have taken them long term. While opioid reduction efforts have had generally beneficial effects, there have been unintended consequences. Abrupt reduction or discontinuation has been associated with harms that include serious withdrawal symptoms, psychological distress, self-medicating with illicit substances, uncontrolled pain, and suicide. Key questions remain about when and how to safely reduce or discontinue opioids in different patient populations. The consensus panel recommendations include clear, evidence-informed steps providers can take to clarify the indications for tapering long-term opioids and how to ensure patient safety throughout each step of a taper.

“Clinicians face dilemmas when caring for patients taking opioids, as various guidelines, patient preferences, and clinical impressions of risks and benefits may be in conflict,” says AAPM Past President Edward Covington, MD, lead author of the AAPM Foundation project. “Our findings indicate that harm can result from abrupt tapers and emphasize the importance of balancing patient collaboration and desires with clinician responsibility to prescribe wisely.”

The consensus panel’s recommendations are the result of a rigorous and collaborative process, including consensus-building discussions, analysis, and interpretation of data. “We convened a consensus panel of experts in long-term opioid treatment, substance use disorders, and opioid reduction with the goal of providing useful criteria for dose continuation versus reduction along with strategies for the comfortable and humane tapering of opioids, when indicated,” Dr. Covington said.

Hear more from Dr. Covington by viewing this video interview he conducted with co-author Mark Sullivan, MD PhD.

Recommendations also address topics such as patient factors that increase risk with long-term opioid therapy, indications for tapering long-term opioids, common withdrawal symptoms, and buprenorphine initiation in patients on opioids for pain. Several of the panelists presented a Spotlight Session about this project at AAPM’s 2020 Annual Meeting. A recording of this session is available on demand in the AAPM Education Center at no cost for members and $25 for nonmembers.

About AAPM

The American Academy of Pain Medicine is the premier medical association for pain clinicians and their treatment teams with some 2,000 members. Now in its 36th year of service, the Academy’s mission is to advance and promote the full spectrum of multidisciplinary pain care, education, advocacy, and research to improve function and quality of life for people in pain. Information is available on the Academy’s website at painmed.org.

About AAPM Foundation
The AAPM Foundation was created in 2011 to support the American Academy of Pain Medicine’s (AAPM) efforts. The Foundation supports AAPM’s core purpose to optimize the health of patients in pain and eliminate the major health problem of pain by advancing the practice and the specialty of pain medicine. Information is available on the Foundation’s website at aapmfoundation.org.

Chatbots Delivering Psychotherapy Help Decrease Opioid Use After Surgery

Patients who need surgery to fix major bone fractures use fewer opioid pills after their procedure if they’re reminded of six “core principles” that include: values, acceptance, present moment awareness, self-as-context, committed action, and diffusion. Two reminders were sent daily as text messages to their phones for two weeks after their procedure from an automated “chatbot.” Full story.

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