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March 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. EducationHave You Registered?Explore and discover what APS has to offer at the 33rd Annual Scientific Meeting.
Don't miss out—register today! NEW This Year: Speaker Insight SeriesAPS is giving you an opportunity to hear directly from annual meeting speakers. The Speaker Insight Series will give you a preview of what you can expect from their sessions at this year’s meeting and how they can influence the way you look at pain management, research, and the future of pain. Speakers include
ASM Feature: Keynote Address on Healthcare ReformHealth Care’s Most Important Reform—The Provider This raises critical questions. Can the academic medicine community reform itself, starting with the provider? Can we reform the way we think, interact with patients, or use technology? Can we deconstruct and rewire? There is no healthcare reform without provider reform, but providers are famously headstrong. What now? Learn about Dr. Newman’s session from this Speaker Insight Series video! 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. 2014 Poster Abstracts LiveThe poster abstracts for the 33rd Annual Scientific Meeting will be available on The Journal of Pain’s online searchable abstract database beginning April 4. Please visit the Abstracts Archive page of the APS website in April to search and view the abstracts prior to the annual meeting in Tampa. MembersMember Spotlight![]() Deb Gordon, DNP RN FAAN How has APS membership been of value to you and your professional development? What is your area of specialty? What has been a highlight of your work? Perhaps you and your staff are proud of a certain project or accomplishment. What sparked your interest in working in your field? Briefly describe your career path. Who is your favorite role model—and why? Member Benefit: Continuing Education OpportunitiesThe intent of the APS continuing education (CE) program is to improve pain care by advancing the education of physicians, nurses, pharmacists, psychologists, scientists, and other professionals in the treatment of individuals with acute/chronic pain, and by supporting the development of pain research. You have a variety of opportunities for CE available through APS. These opportunities not only meet requirements for the variety of disciplines represented in the society, but they also are focused around your interest in pain:
If you have any questions regarding APS’s CE activities, please call 847.375.4715 or e-mail info@americanpainsociety.org. SummariesThe Journal of Pain HighlightsThe following highlights summarize selected articles from The Journal of Pain (Volume 15, Number 3, March 2014 Issue). ![]() Health Care Professionals' Reactions to Patient Pain: Impact of Knowledge About Medical Evidence and Psychological Influences Without seeing clear medical evidence, physicians are less likely to believe patients about their pain complaints and often think they are being deceived. Researchers from Belgium and Canada investigated the impact of the presence or absence of medical evidence on healthcare practitioner appraisals of pain and pain treatments. They also examined the effect of variations in patient pain behaviors for moderating physician responses. The study is the first to use video observations instead of written case reports to enable doctors to observe patients’ full body pain behaviors. Fifty-two general practitioners and 46 physiotherapists viewed video sequences of four patients manifesting their pain, and vignettes were added to describe the presence or absence of medical evidence to explain possible causes for the exhibited pain. The authors noted that previous research showed that healthcare practitioners may dislike patients who lack clear medical evidence for their pain and may have more doubts about the pain symptom validity without clear medical explanations. Results showed that the absence of medical evidence was related to practitioner responses indicating lower perceived pain and daily activity interference, less sympathy, decreased lower expectations of medication impact, and less self-efficacy. Further, the absence of medical evidence was related to less positive physician evaluations of the patients and higher suspicion for deception. Also, the impact of psychosocial influences was evident only when a patient displayed a high level of pain behavior. The authors concluded that their findings could explain why some patients are convinced their doctors do not believe they have pain. Less sympathy, therefore, may adversely influence the doctor-patient relationship and outcomes, especially if there is insufficient pain relief. Deep Brain Stimulation as a Treatment for Neuropathic Pain: A Longitudinal Study Addressing Neuropsychological Outcomes Surgery to implant small electrodes in the brain that stimulate targeted neural regions can relieve neuropathic pain symptoms and significantly improve mood, anxiety, and overall quality of life. A British research team evaluated 18 patients who had undergone the deep brain stimulation procedure for pain relief. The intent was to determine if reduced pain resulting from the procedure also improved overall quality of life and emotional wellbeing. During the surgery, an electrode was placed inside the skull. If the externally induced electrical stimulation provided adequate analgesia after 7 days, the electrode was implanted in the brain with a pulse generator for ongoing pain treatment. The authors reported that their study confirmed previous research showing that electrical brain stimulation is effective for reducing neuropathic pain intensity. Thirty-nine percent of study subjects said they had substantial pain reduction. As expected, significant improvements in mood and anxiety were observed, especially among subjects who reported significant pain relief. PAIN HighlightsThe following highlights summarize selected articles from PAIN (Volume 155, Number 3, March 2014 Issue). ![]() Reduced Pain Inhibition Is Associated with Reduced Cognitive Inhibition in Healthy Aging More than 38% of older people living in healthcare institutions and 27% living in private households are affected by chronic pain. The analgesic effect of heterotopic noxious counter-stimulation (HNCS) has been shown to decrease in older people, and some neuropsychological studies have suggested a reduction in cognitive inhibition with normal aging. Taken together, these findings may reflect a generalized reduction in inhibitory processes. This study assessed whether the decline in the efficacy of pain inhibition processes is associated with decreased cognitive inhibition in older people. Healthy young (18–46 years of age; n = 21) and older (56–75 years of age; n = 23) adult volunteers participated in one experimental session to assess the effect of HNCS (cold pain applied on the left forearm) on shock pain and RIII reflex induced by transcutaneous electrical stimulation of the right sural nerve. In the same session, participants also performed a modified Stroop task, including a target condition requiring the frequent switching between inhibition and no inhibition of the meaning of color words. This study is the first to examine the effects of normal aging on HNCS analgesia using a measure of spinal nociceptive transmission. It shows a decrease of inhibitory effects of HNCS on pain perception and spinal nociception with healthy aging. The decrease of HNCS effect on RIII reflex significantly correlated with a decrease in the efficacy of cognitive inhibition processes with aging. Together, these results suggest an overall decline of inhibition systems occurring with aging. This study provides ground for future investigations of the cerebral mechanisms underlying the effect of normal aging on pain control and cognitive executive processes. Pain Sensitivity Is Inversely Related to Regional Grey Matter Density in the Brain Differences in grey matter may reflect neural processes contributing to the construction and modulation of pain in healthy individuals. Previously published findings highlight an important relationship between pain thresholds and cortical thickness. However, the relationship between suprathreshold differences in pain sensitivity and regional grey matter is not yet understood. To address this question, investigators executed a voxel-based morphometry (VBM) analysis to determine whether grey matter density (GMD) is associated with individual differences in pain sensitivity as defined by pain intensity ratings to suprathreshold stimuli. Because pain-related differences in brain morphology vary in direction and across regions, investigators examined both positive and negative relationships between GMD and individual differences in pain sensitivity across the entire brain in a fashion unconstrained by a priori hypotheses. Using a whole-brain VBM analysis, investigators identified an inverse relationship between pain sensitivity and GMD in the posterior cingulate cortex (PCC), precuneus (PCu), intraparietal sulcus (IPS), inferior parietal lobule (IPL), and somatosensory cortex (SI). These differences in brain structure were identified an average of 5.44 days after psychophysical assessment. This relationship between brain structure and pain sensitivity may reflect relatively stable processes that contribute substantially to individual differences in pain sensitivity. These results indicate an inverse relationship between pain sensitivity and GMD in areas of the default mode network (DMN), such that people who are highly sensitive to pain have less grey matter in the PCC and PCu, and people who are least sensitive to pain have more grey matter in these areas. More research is needed to determine the direction of this relationship and the sources behind the grey matter differences. In the present investigation, the relationship between GMD and pain sensitivity was evident over a period of more than 5 days on average, suggesting a relatively stable phenomenon. Accordingly, these kinds of morphologic differences can serve as novel predictors of pain sensitivity and provide a foundation for the development of biomarkers for pain diagnosis, classification, prevention, and treatment. The Clinical Journal of Pain HighlightsThe following highlights summarize selected articles from The Clinical Journal of Pain (Volume 30, Number 3, March 2014 Issue). ![]() Bidirectional Associations Between Pain and Physical Activity in Adolescents It has been estimated that up to 75% of youth with chronic pain withdraw from participating in sports activities. These children and adolescents also experience reductions in other activities, including gym class, playing, running, and walking. This is cause for concern, because limitations in activity are related to decreased overall physical functioning, reduced psychosocial functioning, and reduced quality of life in youth with chronic pain. The aims of this study were to examine daily levels of pain and physical activity in a clinical sample of adolescents with chronic pain as compared with healthy youth; reciprocal associations between pain and physical activity; and predictors of activity and pain, including sleep quality, mood ratings, and medication use across the two groups. Investigators hypothesized that youth with chronic pain would have more pain and lower physical activity than pain-free youth. They also hypothesized a bidirectional relationship between pain and physical activity, such that physical activity would predict end-of-day pain and end-of-day pain would predict physical activity levels the next day. Finally, they hypothesized that worse mood, poor sleep quality, and higher medication use would be associated with higher daily pain levels and reduced daily physical activity. Although mood was related to pain and overall activity, daily mood ratings did not contribute to the daily temporal relationship between pain and activity. Participants were 119 adolescents (59 with chronic pain and 60 healthy), ages 12–18 years, and 71% were female. Researchers completed 10 days of actigraphic monitoring of physical activity and daily electronic diary recordings of pain intensity, medication use, sleep quality, and mood. Linear mixed models assessed daily associations among physical activity and pain. Daily mean and peak activity were used for analyses. Higher pain intensity was associated with lower peak physical activity levels on the next day, and greater medication use predicted lower mean physical activity levels the same day. Higher mean physical activity levels predicted lower pain intensity ratings at the end of the day but only among adolescents with chronic pain. These findings of a temporal path between changes in activity and subsequent pain intensity highlight the importance of incorporating a focus on continued activity despite high pain intensity in a manner consistent with a rehabilitation approach when treating youth with chronic pain. Has Catechol-O-Methyltransferase Genotype (Val158Met) an Influence on Endocrine, Sympathetic Nervous and Humoral Immune Systems in Women with Fibromyalgia Syndrome? Stress can play an important role in etiology of fibromyalgia syndrome (FMS) by activating the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS) and altering the immune system. This study examined the influence of catechol-O-methyltransferase (COMT) Val158Met genotypes on salivary markers of the HPA axis (cortisol), SNS (a-amylase), and immune (IgA) systems in women with FMS. Investigators hypothesized that women with FMS with the Met/Met genotype would exhibit lower salivary cortisol concentrations and a-amylase activity associated with reduced salivary flow rate than those with Val/Val or Val/Met genotypes; women with FMS with the Met/Met genotype would exhibit lower IgA concentrations than those with Val/Val or Val/Met genotypes; and women with FMS with the Met/Met genotype would exhibit higher intensity of pain and disability than those with the Val/Val or Val/Met genotypes. Seventy-six women with FMS diagnosed according to the American College of Rheumatology criteria participated in the study. Salivary cortisol, a-amylase activity, salivary flow rate, and IgA concentration were collected from nonstimulated saliva. A numerical pain rating scale (0–10) was used to assess the intensity of pain, and functional ability was determined using the Fibromyalgia Impact Questionnaire. After amplifying Val158Met polymorphisms by polymerase chain reaction, three COMT genotypes were considered: Val/Val, Val/Met, and Met/Met. Results indicate that women with FMS with the Met/Met genotype exhibit higher a-amylase activity, lower salivary flow rate, and lower IgA concentration than women with FMS carrying the Val/Val or Val/Met genotype. No differences in salivary cortisol concentrations were found. These results provide evidence of a link between Val158Met polymorphism and dysfunctions in the SNS and humoral immune system in women with FMS. These findings may help to shed light on why some patients with FMS exhibit a more severe form of the disease and aid in the investigation of proper genetic therapeutic options. ResearchCongratulations to the 2014 Sharon S. Keller Chronic Pain Research Program Grant RecipientsThe American Pain Society is pleased to announce the second year of the Sharon S. Keller Chronic Pain Research Program. The purpose of this grant program is to fund research projects that investigate the effectiveness of novel non-pharmacologic treatments for pain, and mechanisms underlying these treatment effects. ![]() Emily Bartley, PhD ![]() Kushang Patel, PhD MPH ![]() Kim Sibille, PhD ![]() Rebecca Wells, MD MPH SocietyBoard Updates: Election ResultsAPS is pleased to announce the following members have been elected to serve on the APS 2014 Board of Directors and 2014–2015 Nominating Committee. 2014 BOARD OF DIRECTORS ![]() Director-at-Large ![]() Director-at-Large ![]() Director-at-Large NOMINATING COMMITTEE ![]() Past President ![]() Past President ![]() Member ![]() Member ![]() Member ![]() Member Important DatesAnnual Scientific Meeting 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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