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April 2014 | |||||||||||||
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Funding AnnouncementsDevelopment of Opioid and Adjuvant Fixed Combination Dosage Forms for the Treatment of Chronic Pain with Reduced Addiction Potential (R41/R42)This funding opportunity announcement seeks small business organizations to develop opioid and adjuvant drug combinations within a single dosage form for treatment of a pain condition. The drug combination should provide improved analgesia when compared with the same dose (morphine equivalents) of opioid monotherapy. Such dosage forms should minimize opioid exposure while optimizing analgesia to reduce risk of addiction and limit severity of other opiate adverse effects. When designing this new product, investigators should consider FDA guidance (21 CFR 300.50) and address the following issues. Both of the agents contained in the proposed new product should currently have at least one existing FDA-approved indication, as well as some existing clinical evidence to support the use of the chosen adjuvant: opioid combination and a reasonable expectation that the combination will present minimal drug-drug interaction concerns. The application should emphasize available evidence that the chosen drugs and doses in the combination will allow a substantial patient population to gain sufficient analgesic value from the contained opioid dose while the adjuvant dose remains within a safe and effective "therapeutic window." One example of a potentially viable adjuvant is gabapentin, a drug known to reduce neuropathic pain and to which patients typically exhibit no more than mild adverse effects. Gabapentin does not typically induce substantial drug interactions because it is eliminated as parent drug by renal excretion and does not extensively bind to blood proteins. The adjuvant should be chosen for a capacity to increase overall analgesia, rather than an ability to reduce opioid adverse effects. For example, inclusion of a poorly absorbed opioid receptor antagonist, with the intent of reducing constipation, would not be considered of high programmatic interest. The combination dosage form proposed by the application should provide sustained relief when it is the only analgesic used and is administered no more than three times in a 24-hour period. The formulation should be such that a patient with reasonable mobility is able to self-administer the drug (e.g., oral dosage form). The application should propose late-stage drug development-oriented studies that significantly drive the project towards an ultimate aim of a New Drug Application [505(b)(1 or 2)] or Abbreviated New Drug Application [505(j)] for the treatment of a long-term pain condition. Studies planned for Phase 1 of the project should focus on issues that concern the feasibility of the project. The exact nature of such studies will differ depending on the proposed drug combination project. Studies that might be appropriate for Phase 1 STTR applications include, but are not limited to
Examples of projects appropriate for Phase 2 of an STTR award might include
Submissions will be accepted beginning March 5 and letters of intent are due 30 days before applications are due. For more information about this funding opportunity, visit the NIH grants page. Neurobiology of Migraine (R01)This funding opportunity announcement (FOA) is issued by the National Institute of Neurological Disorders and Stroke (NINDS) in conjunction with the National Institutes of Health (NIH) Pain Consortium. It solicits R01 grant applications from institutions and organizations to perform innovative research that will elucidate the mechanisms underlying migraine; expand our current knowledge of the role of genetic, physiological, biopsychosocial, and environmental influences in migraine susceptibility and progression; and explore new therapeutic targets and therapies for acute migraine management and longer term prevention. The National Center for Complementary and Alternative Medicine (NCCAM) is interested in research that would elucidate the mechanisms by which a given complementary or integrative health approach beneficially affects migraine, either as an acute intervention or prophylactically. For this FOA, complementary or integrative health approaches could include those within the “mind and body” domain but not in the “natural products” domain and would include, but are not limited to, meditation, mindfulness, yoga, tai chi, qi-gong, acupuncture, massage, and spinal manipulation. The primary outcomes for these studies should be directly focused on the mechanism(s), though it may be appropriate to have secondary outcomes that assess clinical outcomes. There should be sufficient prior data to indicate either efficacy or effectiveness of the proposed complementary or integrative health approach. The National Institute for Dental and Craniofacial Research (NIDCR) is interested in the neurobiological mechanisms underlying migraine headache as they pertain to overlaps with pathophysiological mechanisms of chronic temporomandibular and other orofacial pain disorders. Research examining common genetic, environmental, neurobiological, and biobehavioral factors underlying the co-occurrence of these disorders is encouraged. NIDCR is interested in funding meritorious research that focuses on studies addressing the comorbidity of temporomandibular and other orofacial disorders and migraine headache. NIDCR is interested in the development of diagnostic, intervention, and novel therapeutic tools for headache pain associated with a variety of communication disorders such as tinnitus, Meniere’s disease, odynophagia, and burning mouth syndrome. Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director or principal investigator (PD or PI) is invited to work with his or her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Submissions will be accepted beginning May 5. For more information about this funding opportunity, visit the NIH grants page. EducationRegister Onsite So You Don’t Miss Out!Join your colleagues in Tampa, FL, for the 33rd Annual Scientific Meeting, April 30–May 3. At the annual scientific meeting, you will discover current information about the research, diagnosis, treatment, and management of acute, chronic cancer, noncancer, and recurrent pain.
Online registration is now closed, but you can still register onsite during the following times: APS 34th Annual Scientific Meeting: Call for Symposia Opens April 30APS will hold its 34th Annual Scientific Meeting May 13–16, 2015, in Palm Springs, CA. The APS Scientific Program Committee invites the submission of proposals for symposia to be presented during the Palm Springs meeting. The call for symposia will be available on the APS website beginning Wednesday, April 30. The Scientific Program Committee requests that all proposals reflect APS’s multidisciplinary approach to pain and should, therefore, include speakers who represent varied areas of pain research and treatment. Specifically, the committee will be looking for proposals that include perspectives from physicians, nurses, physical therapists, psychologists, basic scientists, pharmacists, and dentists. Moderators should seek participation from a varied group of faculty (the maximum number of participants per proposal is 1 moderator and 3 additional speakers), and several disciplines and facilities or institutions should be represented in each proposal. Translational proposals that include both basic and clinical science are encouraged. Moderators and faculty will be notified in October 2014 regarding selection of their proposals. All presenters will receive complimentary meeting registration. Other terms of participation will be communicated to speakers upon acceptance of the proposal. The submission deadline is Monday, July 14. Recognizing Excellence: 2014 Clinical Centers of Excellence AwardsThe 2014 Clinical Centers of Excellence (CCOE) awards will be presented at the President's Recognition Reception on Thursday, May 1, 6:30–8 pm at the Tampa Marriott Waterside Hotel & Marina during the 33rd Annual Scientific Meeting. The evening's events will include a cocktail reception, remarks from the APS President, and an awards presentation. Congratulations to the following winners: ![]() UC San Diego Medical Center: Center for Pain Medicine ![]() Connecticut Children's Medical Center: Division of Pain and Palliative Medicine ![]() Pain Consultants of East Tennessee ![]() The University of Texas MD Anderson Cancer Center, Department of Pain Medicine ![]() VA Greater Los Angeles Pain Management Program 2014 Poster Abstracts LiveThe poster abstracts for the 33rd Annual Scientific Meeting can now be accessed through The Journal of Pain’s online searchable abstract database. Please visit the Abstracts Archive page of the APS website to search and view the abstracts prior to the annual meeting in Tampa. Pain Care for Primary Care ConferenceIn collaboration with the Journal of Family Practice, APS will host a 3-day educational conference, “Pain Care in Primary Care” (PCPC). The conference is intended to help primary care physicians, advanced practice nurses, and physician assistants improve their understanding of pain and pain management, and improve care for their patients with acute and chronic pain. PCPC speakers will be nationally known experts in pain care and pain research. The course will offer continuing education (CME/CNE) credit/contact hours for physicians, nurses, and physical assistants. PCPC will be held in Orlando, July 17–19. Learn more. Dr. Chen of National Institute on Aging to Speak at Geriatric SIG Meeting in TampaDr. Wen Chen, a program officer from the National Institute on Aging (NIA), will be speaking at the APS Geriatric Shared Interest Group (SIG) Meeting taking place May 1, 5:15–6:15 pm during the 2014 Annual Scientific Meeting (ASM) in Tampa, FL. Dr. Chen will discuss pain in aging research supported by the NIA, as well as the current initiatives and funding opportunities. To register for this session, please select it as part of your ASM registration. MembersMember Spotlight![]() Deirdre Logan, PhD How has APS membership been of value to you and your professional development? What is your area of specialty? What initially sparked your interest in working in your field? Briefly describe your career path. My career path began with doctoral training in clinical child psychology at the University of Michigan, where I also completed a psychology internship working in a center for children and families. After internship training, I went on to a postdoctoral fellowship in pediatric psychology at The Children's Hospital Of Philadelphia (CHOP), where I began working primarily with children facing pain conditions and painful procedures. I then joined the clinical faculty at CHOP within the Pain Management Program in the department of anesthesia. A few years later we relocated to Boston, where I have worked at Boston Children's Hospital in the departments of anesthesia and psychiatry for the past 10 years. What has been a highlight of your work? Perhaps you and your staff are proud of a certain project or accomplishment. Welcome New MembersAPS is pleased to welcome and recognize the following new members for February and March 2014:
SummariesThe Journal of Pain HighlightsThe following highlights summarize selected articles from The Journal of Pain (Volume 15, Number 4, April 2014 Issue). ![]() Methadone Safety: A Clinical Practice Guideline from the American Pain Society and College on Problems of Drug Dependence, in Collaboration with the Heart Rhythm Society Improved physician education and patient counseling about methadone safety and electrocardiography (ECG) monitoring to identify patients at high risk for cardiac problems will lead to safer use of the medication, according researchers. Methadone is a synthetic opioid narcotic used to treat opioid addiction and chronic pain. Safety of the drug has been a major clinical concern in recent years. Deaths in the United States from methadone overdoses have increased from 800 in 1999 to 4,900 in 2008. The increase in mortality has been substantially higher than for any other opioid medication and is attributed to a sharp rise in prescribing methadone for chronic pain. Previous methadone guidelines covered prevention of cardiac arrhythmias caused by methadone. These guidelines did not address methadone safety issues aside from cardiovascular risks. In preparing the new methadone safety guideline, the APS expert panel reviewed more than 3,700 scientific abstracts. Under the direction of the Oregon Evidence-Based Practice Center, the group reviewed evidence assessing a variety of topics related to methadone safety. The intent of the guideline is to provide evidence-based recommendations for use of methadone in persons of all ages for treatment of chronic pain in primary care or specialty settings, or for use in licensed opioid addiction treatment programs. The guideline is based on a systematic review of the evidence on methadone safety, and the panel concluded that measures can be taken to promote safer use. Safely prescribing this medication requires clinical skill and knowledge to mitigate risks related to overdose and cardiac arrhythmias. Recommendations in the guideline were rated as strong or weak. Strong recommendations were based on the panel’s assessment that potential benefits outweigh harms or burdens or that potential harms clearly outweigh benefits. Key recommendations include
PAIN HighlightsThe following highlights summarize selected articles from PAIN (Volume 155, Number 4, April 2014 Issue). ![]() Increased Sensitivity to Physical Activity Among Individuals with Knee Osteoarthritis: Relation to Pain Outcomes, Psychological Factors, and Responses to Quantitative Sensory Testing Recent findings suggest that certain individuals with musculoskeletal pain conditions have increased sensitivity to physical activity (SPA) and respond to activities of stable intensity with increasingly severe pain. This study was designed to determine the degree to which individuals with knee osteoarthritis (OA) show heightened SPA in response to a standardized walking task and whether SPA cross-sectionally predicts psychological factors, responses to quantitative sensory testing (QST), and different OA-related outcomes. The 107 adults with chronic knee OA who were enrolled in this study completed self-report measures of pain, function, and psychological factors; underwent QST; and performed a 6-minute walk test during which they rated their discomfort levels. During the first 6-minute walk, mean discomfort ratings increased by 130%. Discomfort levels remained elevated after completing the first walking task and increased an additional 42.4% during the second task. These findings suggest that many people with knee OA show a prolonged sensitized response to routine activities of daily living such as walking. This sensitized response is partially explained by psychological factors. Elevated levels of catastrophizing predicted increased SPA even after controlling for significant covariates. The attentional biases to pain associated with catastrophizing, including vigilance and inability to disengage from pain-related stimuli, appear to partially explain increasing discomfort during physical activity. These cognitive processes are more relevant than emotional factors because depressed mood was not significantly related to SPA in this sample. The present work demonstrates that increased SPA may serve as an important link between psychological risk factors and pain-related disability. Determining whether deconditioning or sensitization processes lead to disability will help to identify effective strategies for disability reduction. These findings also have implications for clinical practice; SPA may prove particularly valuable in predicting which patients are most likely to respond to activity-based treatments. Does the Epidermal Nerve Fibre Density Measured by Skin Biopsy in Patients with Peripheral Neuropathies Correlate with Neuropathic Pain? Different neuropathic pain types such as ongoing burning pain and allodynia are frequent and disabling conditions among patients with peripheral neuropathies. Although the reference standard technique for diagnosing painful small-fiber neuropathies is nerve fiber density assessment by skin biopsy, the relationship between epidermal nerve fiber (ENF) density and neuropathic pain has been unclear. Investigators enrolled 139 consecutive patients with distal symmetric peripheral neuropathy. All patients underwent clinical examination, the Neuropathic Pain Symptom Inventory was used to distinguish the different neuropathic pain types, and a skin biopsy was conducted. Patients were grouped according to the clinically documented presence or absence of neuropathic pain. There was no direct association between neuropathic pain overall and skin biopsy findings (ENF density, axonal swellings, and the axonal swelling/ENF ratio). Despite this negative finding, the similar ENF density in patients with and without ongoing burning pain and the higher ENF density in patients with provoked pain (including mechanical dynamic allodynia) highlight the relationship between the different types of pain and skin biopsy findings. This study shows that ENF density differs in various types of neuropathic pain, supporting the hypothesis that these types of pain arise through distinct underlying mechanisms, and further supports classification of neuropathic pain by sensory profile rather than by etiology. The association between ENF density and provoked pain suggests that in some patients these pain types might be mediated by spared and sensitized nociceptive afferents, providing the rationale for the use of topical drugs. Pain Medicine HighlightsThe following highlights summarize selected articles from Pain Medicine (Volume 15, Number 3, March 2014 Issue). ![]() Caudal vs Transforaminal Epidural Steroid Injections as Short-Term (6 Months) Pain Relief in Lumbar Spinal Stenosis Patients with Sciatica This study evaluated prospectively the efficacy of caudal epidural steroid injection (CESI) and transforaminal epidural steroid injection (TFESI) in lumbar spinal stenosis among patients with sciatic pain. Considering the significant risk and great expense associated with surgery and the similar long-term pain and disability outcomes among patients who do and do not undergo surgery, the possibility that ESIs can prevent even a small percentage of surgeries supports the use of ESIs before making surgical decisions. In this prospective case control study of ESIs, two comparable groups of patients with lumbar stenosis and sciatic pain were injected by the same interventional physician/spine surgeon in different facilities using different techniques (CESI and fluoroscopically assisted TFESI). At 6 months postinjection, significantly more respondents (18/20) experienced pain relief of at least 50% following TFESI. Functionally, all patients in the TFESI group had at least 15 Oswestry Disability Index (ODI) degrees improvement vs. only 3/11 patients in the CESI group. Clinical outcomes in terms of disability and pain improved at 2 weeks, 3 months, and 6 months postinjection for patients receiving injection by both techniques. Patients in the TFESI group had better outcomes at 6 months postinjection than those in the CESI group. Sustained Effectiveness of 10 kHz High-Frequency Spinal Cord Stimulation for Patients with Chronic, Low Back Pain: 24-Month Results of a Prospective Multicenter Study This study investigated the long-term efficacy and safety of paresthesia-free high-frequency spinal cord stimulation (HF10 SCS) for the treatment of chronic intractable pain of the low back and legs. SCS is an accepted treatment for failed back surgery syndrome—the presence of persistent or recurrent back and/or leg pain following spinal surgery. HF10 SCS therapy is a form of SCS that delivers stimulation to the spinal cord via a system of leads and an implantable pulse generator. These investigators previously published 6-month results from a prospective multicenter trial of HF10 SCS for chronic low back pain. Marked reductions in both back and leg pain and associated improvements in quality of life measures were shown. Here they report the 24-month follow-up of efficacy, patient satisfaction, and safety data on these same patients. This study showed long-term improvements in back pain, leg pain, functional capacity, opioid use, and sleep in these patients treated with HF10 SCS. After 24 months of HF10 SCS therapy, 60% of patients reported baseline back pain reductions exceeding 50%, and 71% reported reductions in leg pain of more than 50%. This study shows that the pain relief afforded by HF10 SCS is maintained for at least 24 months. The improvement in Oswestry Disability Index (ODI) at 24 months is both statistically and clinically significant, with a baseline ODI of 55 ± 1 reduced to 40 ± 2 at 24 months. Among subjects, 90% were classified as severely disabled at baseline, and this figure dropped to 49% at 24 months. No adverse events related to the high-frequency stimulation were observed. The positive results of this large prospective trial are encouraging and should inspire further investigation of the role that HF10 SCS may play in treating chronic spinal pain and other chronic pain states. ResearchCongratulations to the 2014 Rita Allen Foundation Award in Pain Grant RecipientsAnnually, APS and the Rita Allen Foundation (RAF) award up to two grants, in the amount of $50,000 for a period of up to 3 years, to research proposals demonstrating the greatest merit and potential for success. During the past 4 years, APS and RAF have awarded eight grants for research proposals focusing on the molecular biology of pain and basic science research in the development of new analgesics. APS congratulates the following winners: ![]() Gregory Scherrer, PhD PharmD ![]() Tuan Trang, PhD 2014 Young InvestigatorsAPS is pleased to grant Young Investigator Travel Awards to 56 trainees to attend the 2014 Annual Scientific Meeting. These individuals will present their research during designated poster sessions. The APS meeting creates a milieu in which scientists and clinicians can share relevant information from their differing perspectives, frequently leading to advances in science and clinical care. Funding for the 2014 Young Investigator Travel Award Program is made possible by grants from the National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Drug Abuse (NIDA), National Center for Complementary and Alternative Medicine (NCCAM), National Institute of Nursing Research (NINR), National Institute on Aging (NIA) and the National Institute for Child Health and Human Development (NICHD). Meryl Alappattu, DPT PT Cindy Barbosa Nunez Kimberly Barnett Daniel Brenner Emilia Maria Cadiz Heather Coleman Marise Cornelius Rogello Coronado, PT CSCS FAAOMPT Timothy Doyle, PhD Raphaël Dufort Rouleau Nichole Emerson Catherine Ferland, PhD Mark Gaertner Rosann Govea Peter Grace, PhD Hanna Grol-Prokopczyk Yvette Güereca Matthew Herbert, MA Xiaoyu Hu Catherine Hubbard, PhD Kali Janes, PhD Anna Kratz, PhD Bethany Kuhn Edward Lannon Sanghee Lee Joshua Little, DC PhD Carrie Maloy Katherine Martucci, PhD Zare Melyan, PhD Aaron Mickle Rachel Moericke, MA Gyasi Moscou-Jackson, MHS BSN RN Jennifer Naylor, PhD Shreela Palit Kristofer Rau, PhD Mercedes Robinson Jessica Ross Gabriela Ruchelli Taylor Rush, PhD Luma Samawi Vijay Samineni, PhD Mansi Shah Tayler Sheahan Andrew Shepherd, PhD Soumitri Sil, PhD Corey Simon, DPT PT Allison Smith, PhD Katherine Stockstill, MS Maral Tajerian, PhD MSc Chloe Taub Calia Torres Manouela Valtcheva Kiran Vasudeva Tracy Wilson-Gerwing, PhD Sarah Woller, PhD Mayday Pain & Society Fellowship: Call for Final Year of ApplicationsThe Mayday Fund, a New York City private foundation dedicated to alleviating the incidence, degree, and consequence of human physical pain, announced on March 17 that it will begin accepting applications for the 2014 Mayday Pain & Society Fellowship: A Media & Policy Fellows Initiative. This is the final year of the program, which is designed to equip physicians, nurses, pharmacists, social workers, scientists, policy experts, and legal scholars in pain management with the necessary communications skills to become effective advocates and spokespeople throughout their career on pain issues in the United States and Canada. The landmark 2011 Institute of Medicine report, “Relieving Pain in America,” recognized pain as a serious public health challenge that affects 100 million people and prescribed a set of recommendations intended to address undertreated pain and challenges related to pain care and delivery, education, and research. The pain experts chosen for the Mayday Fellowship are expected to take up one or more recommendations as a strategic communications goal to educate the media, policymakers, and other decision-makers about pain management. Once selected, the Mayday Fellows will attend a 4-day training workshop in Washington, DC, on October 19–22 to develop skills in connecting with local and national media, writing commentary and engaging in social media, building key relationships within their institutions, and talking with federal and state-elected officials and other decision-makers. Each fellow will have 5 months of one-on-one communications coaching and develop and implement a strategic advocacy outreach plan. The fellowship program begins with the workshop and runs through March 2015. Candidates must be accomplished experts, clinicians, or researchers in pain management, and able and willing to devote a significant amount of time using the skills learned throughout the fellowship. They must show an interest in going beyond their professional pursuits to make an impact in the pain field and demonstrate their commitment to long term communication and public outreach. To apply, visit www.MaydayFellows.org. For more information, contact Dionne Dougall-Bass at 301.961.5803 or dionne@burnesscommunications.com or Nick Seaver at 301.280.5727 or nseaver@burnesscommunications.com. Important DatesAnnual Scientific Meeting 2015 Call for Symposia—Open 2015 Call for Symposia—Deadline Call for SubmissionsDo you have a topic that is relevant to APS members? Is there a member who is doing work that APS should spotlight? Is there a funding opportunity APS members need to know about? Please submit stories, events, and more to enews@americanpainsociety.org for consideration. |
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