Mark S Wallace

University of California, San Diego, San Diego, California, United States

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Publications (145)514.26 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: to assess the long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray (FPNS) in patients with breakthrough cancer pain (BTCP). a multicenter, open-label study. patients with chronic cancer pain treated with > or = 60 mg/d oral morphine or equivalent experiencing 1-4 episodes per day of BTCP. all patients entered into a 16-week treatment phase after undergoing a dose-titration phase with FPNS. safety and tolerability were assessed by adverse events (AEs) and by nasal tolerability assessments. Consistency of effect was monitored through additional rescue medication use and FPNS dose change. four hundred three patients were included in the safety analyses. Of these, 356 patients entered the treatment phase and 110 patients completed the study. FPNS was self-administered for 42,227 episodes. During the treatment phase, 99 patients (24.6 percent) reported treatment-related AEs; most were mild or moderate and typical of opioids. Serious AEs were reported by 61 patients (15.1 percent), but only five were considered related to study drug. Of the 80 deaths that occurred during this study, one was assessed as possibly related to study drug. Nasal assessments revealed no significant local effects. No additional rescue medication was required after 94 percent of FPNS-treated episodes. More than 90 percent of patients required no increase in their initial dose of FPNS. FPNS use for BTCP was associated with AEs, typical of opioids, with no evidence of nasal toxicity. A large proportion of BTCP episodes were treated with a single dose, and doses remained stable over the 4-month period.
    Journal of opioid management 09/2010; 6(5):319-28. DOI:10.5055/jom.2010.0029
  • Mark S Wallace, Richard L Rauck, Timothy Deer
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    ABSTRACT: Ziconotide is a nonopioid intrathecal analgesic used to manage moderate to severe chronic pain. Although ziconotide is approved in the United States for intrathecal monotherapy only, it is often used in combination with other intrathecal drugs in clinical practice. The need exists for a critical assessment of the currently available published literature on ziconotide combination therapy. This review summarizes and evaluates the publications from preclinical and clinical peer-reviewed experiments that have investigated the safety and effectiveness of ziconotide in combination with a variety of other drugs. Eleven relevant publications were identified through a systematic search of multiple databases. In preclinical studies, additive or synergistic antinociceptive effects were discovered when ziconotide was used in combination with morphine, clonidine, or baclofen; however, no additional antinociceptive effects were observed when bupivacaine was added to ziconotide therapy. Safety data from animal studies revealed that ziconotide did not exacerbate morphine-induced respiratory depression, or clonidine-induced hypotension or bradycardia; however, ziconotide did potentiate morphine-induced hypotension and inhibition of gastrointestinal tract motility. Results from 2 open-label trials indicated that combination ziconotide and morphine therapy produced greater analgesia than was produced by the use of either drug alone. Preliminary support for the use of ziconotide in combination with morphine, baclofen, or hydromorphone was provided by case studies. Although clinical and preclinical studies provide some support for the use of ziconotide in combination with morphine, hydromorphone, clonidine, or baclofen, strong evidence-based data are limited. Controlled, long-term clinical trials are warranted.
    The Clinical journal of pain 09/2010; 26(7):635-44. DOI:10.1097/AJP.0b013e3181e017df · 2.70 Impact Factor
  • PM&R 09/2010; 2(9):S31. DOI:10.1016/j.pmrj.2010.07.085 · 1.66 Impact Factor
  • Journal of Pain 04/2010; 11(4). DOI:10.1016/j.jpain.2010.01.155 · 4.22 Impact Factor
  • Source
    Erin F Lawson, Mark S Wallace
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    ABSTRACT: Since the late 1980s, intrathecal (IT) analgesic therapy has improved, and implantable IT drug delivery devices have become increasingly sophisticated. Physicians and patients now have myriad more options for agents and their combination, as well as for refining their delivery. As recently as 2007, The Polyanalgesic Consensus Conference of expert panelists updated its algorithm for drug selection in IT polyanalgesia. We review this algorithm and the emerging therapy included. This article provides an update on newly approved as well as emerging IT agents and the advances in technology for their delivery.
    Current Pain and Headache Reports 02/2010; 14(1):8-16. DOI:10.1007/s11916-009-0092-z · 2.26 Impact Factor
  • James G Modir, Mark S Wallace
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    ABSTRACT: The UV-B pain model utilizes ultraviolet light to induce a small area of inflammation allowing assessment of mechanical and thermal thresholds. Pharmacologic testing has mainly focused on reduction of primary hyperalgesia, although the effect of analgesics on secondary hyperalgesia has also been investigated. The model requires an instrument to precisely generate controlled UV-B tissue hyperalgesia. Initially, a minimum dose to induce tissue hyperalgesia is determined; subsequently, dosages are delivered in set quantities. Tissue is then assessed for inflammation using color Doppler imaging or flare measurements. Heat pain thresholds and pain tolerance are often evaluated using a commercially available thermal sensory testing device. Analgesics can be administered to determine the influence on these clinical endpoints.
    Methods in molecular biology (Clifton, N.J.) 01/2010; 617:159-64. DOI:10.1007/978-1-60327-323-7_12 · 1.29 Impact Factor
  • James G Modir, Mark S Wallace
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    ABSTRACT: The cold pressor test is a reliable pain model in which subjects submerge their hands and forearms into ice water while onset to pain, pain intensity, and tolerance are assessed. Although originally developed as a model for hypertension, the paradigm leads to development of reproducible pain responses allowing assessment to analgesic medications. However, analgesic variability to various medications has been observed. A recent study suggests that methodological discrepancies may contribute to such inconsistencies. The model may be more reproducible by utilizing consistent protocols.
    Methods in molecular biology (Clifton, N.J.) 01/2010; 617:165-8. DOI:10.1007/978-1-60327-323-7_13 · 1.29 Impact Factor
  • James G Modir, Mark S Wallace
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    ABSTRACT: The heat/capsaicin sensitization and intradermal capsaicin injection models are safe and noninvasive paradigms to generate stable, long-lasting, and reproducible injury capable of producing an area of both primary and secondary hyperalgesia. Risk of skin injury is substantially reduced since lower levels of thermal and chemical irritation produce long-lasting cutaneous hyperalgesia. Rekindling sustains central sensitization by providing peripheral nociceptive input. The intradermal capsaicin model has been widely used to test analgesic efficacy for a wide range of analgesics. Unlike the heat/capsaicin sensitization model, intradermal capsaicin results in a brief painful stimulus followed by a long lasting area of secondary hyperalgesia. The intradermal injection of capsaicin results in a transient, intense stinging sensation at the site of injection (e.g. heat allodynia) followed by a persistent area of secondary tactile allodynia.
    Methods in molecular biology (Clifton, N.J.) 01/2010; 617:169-74. DOI:10.1007/978-1-60327-323-7_14 · 1.29 Impact Factor
  • Mark S Wallace, Gordon Irving, Verne E Cowles
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    ABSTRACT: Postherpetic neuralgia (PHN) is a neuropathic pain syndrome that may develop subsequent to healing of herpes zoster rash. This study aimed to determine the efficacy and safety of gabapentin extended-release (gabapentin ER) tablets for the treatment of patients with PHN and to determine whether optimal benefits might be achieved with once-daily (QD) or divided-dose (DD) administration. This was a 10-week, randomized, double-blind, placebo-controlled, multicentre trial comparing gabapentin ER (total daily dose 1800 mg) either QD or as an asymmetrical DD with placebo in 407 patients with post-zoster pain for >or=3 months and a baseline average daily pain score (ADP)>or=4 on a 0-10 Likert numerical rating scale. The primary efficacy outcome was the ADP score mean change from baseline to week 10 using baseline observation carried forward (BOCF). Secondary efficacy outcomes included changes to week 10 in last observation carried forward (LOCF) ADP score, LOCF average daily sleep interference score, Short-Form McGill Pain Questionnaire score, Neuropathic Pain Scale score, and Brief Pain Inventory score. Of 407 randomized patients, 400 were included in the intent-to-treat population (gabapentin ER QD, n=134; gabapentin ER DD, n=135; placebo, n=131). Between-group differences in the least squares (LS) mean changes in BOCF ADP scores did not reach statistical significance (gabapentin ER QD -1.85 [p=0.110 vs placebo]; gabapentin ER DD -1.72 [p=0.255 vs placebo]; placebo -1.42). In the LOCF analysis, the LS mean ADP score for the gabapentin ER QD group, but not for the DD group, improved compared with placebo (gabapentin ER QD, -2.28; p=0.032 vs placebo). Improvements compared with placebo were also observed in the gabapentin ER QD group, but not for the DD group, for mean daily sleep interference scores (gabapentin ER QD, -2.49; placebo, -1.63; p<0.001). Most adverse events (AEs) were mild or moderate. Among gabapentin-treated patients, 12% and 11% withdrew due to AEs, most commonly for dizziness (2% and 3%), in the gabapentin ER QD and DD groups, respectively. Treatment-related AEs in the gabapentin ER-treated groups occurred in 31% of patients. The most common AEs in the gabapentin ER QD and DD groups included dizziness (10% and 15%), headache (4% and 7%), somnolence (3% and 7%) and peripheral oedema (5% and 5%), respectively. The primary efficacy endpoint for this study of gabapentin ER was not met, most likely due to the unexpectedly large placebo response. Outcomes on secondary endpoints suggest the potential efficacy of gabapentin ER QD. Gabapentin ER was well tolerated in this study. [ identifier NCT00335933].
    Clinical Drug Investigation 01/2010; 30(11):765-76. DOI:10.2165/11539520-000000000-00000 · 1.70 Impact Factor
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    ABSTRACT: Neuropathic pain disorders are usually characterized by spontaneous ongoing or intermittent symptoms, stimulus-evoked positive sensory phenomena, and negative sensory phenomena. Spontaneous individual subject specific phenomena are identified in the neurologic history and are quantifiable by means of self-reported neuropathic pain symptoms tools such as scales, inventories, and questionnaires. Negative and positive sensory phenomena are assessed by the neurologic bedside examination and quantitative sensory testing (QST), which refers to psychophysical tests of sensory perception during the administration of stimuli with predetermined physical properties and following specific protocols. QST is able to capture and quantify stimulus-evoked negative and positive sensory phenomena, and as such should become standard if not a critical tool in neuropathic pain research and practice. Although the advent of anatomic and functional imaging modalities is revolutionizing our understanding of the mechanisms of neuropathic pain, only by anchoring such test results to individual subjects' own perceptions via QST can they provide meaningful information about neuropathic pain, which is based on perceptual experience. To yield useful results, QST requires a cooperative subject and carefully standardized methods, including standardization of the stimulus parameters as well as the testing environment, instructions, and evaluation methods. This manuscript provides a concise review of fundamental concepts necessary for understanding the role of QST in the process of eliciting information about sensory abnormalities associated with neuropathic pain and the place of that information in analysis of pain mechanisms. Together with the companion manuscript, this review provides definitions that should help further the use of QST as a diagnostic tool as well.
    The Clinical journal of pain 10/2009; 25(7):641-7. DOI:10.1097/AJP.0b013e3181a68c7e · 2.70 Impact Factor
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    ABSTRACT: Despite a growing interest in neuropathic pain, neurologists and pain specialists do not have a standard, validated, office examination for the evaluation of neuropathic pain signs to complement the neurologic, musculoskeletal, and general physical examinations. An office neuropathic pain examination focused on quantifying sensory features of neuropathic pain, ranging from deficits to allodynia and hyperalgesia, and evoked by a physiologically representative array of stimuli, will be an essential tool to monitor treatment effectiveness and for clinical investigation into the mechanisms and management of neuropathic pain. Such an examination should include mapping of areas of stimulus-evoked neuropathic pain and standardized, reproducible quantitative sensory testing (QST) of tactile, punctuate, pressure, and thermal modalities. We review quantitative sensory testing methodology in general and specific tests for the evaluation of neuropathic pain phenomena. Numerous quantitative sensory testing techniques for dynamic mechanical, pressure, vibration, and thermal sensory testing and mapping have been described. We propose a comprehensive neuropathic pain evaluation protocol that is based upon these available techniques. A comprehensive neuropathic pain evaluation protocol is essential for further advancement of clinical research in neuropathic pain. A protocol that uses tools readily available in clinical practice, when established and validated, can be used widely and thus accelerate data collection for clinical research and increase clinical awareness of the features of neuropathic pain.
    The Clinical journal of pain 10/2009; 25(7):632-40. DOI:10.1097/AJP.0b013e3181a68c64 · 2.70 Impact Factor
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    ABSTRACT: Morphine is often administered by the subcutaneous (SC) route when venous access is difficult to achieve. Hyaluronidase temporarily increases the permeability of SC connective tissues by degrading hyaluronan and has been shown to increase the dispersion and absorption of coadministered molecules. Therefore, hyaluronidase could enhance the pharmacokinetics of subcutaneous morphine. This Phase IIIB, double-blind, randomized, placebo-controlled crossover study compared the pharmacokinetics, safety, and tolerability of morphine administered SC with and without 150U of recombinant human hyaluronidase (rHuPH20) with those of intravenous (IV) morphine administration in 13 patients in a hospice or palliative care setting. Each patient received morphine 5mg parenterally daily for three days by a different method each day: IV, SC plus rHuPH20, and SC plus placebo (normal saline). The primary endpoint was the time to maximum plasma concentration (T(max)) for morphine. Concomitant SC administration of rHuPH20 enhanced the absorption rate of morphine compared with SC morphine with placebo, significantly reducing the mean T(max) from 13.8 to 9.2 minutes, a 33% decrease (P=0.026). The respective values for geometric mean maximum plasma concentration were 94.9 and 107.5nmol/L, a 13% increase (P=0.024), and the area under the plasma concentration vs. time curve values were 7.7 and 7.2micromol x min/L (P=0.23). Morphine plus rHuPH20 appeared to be safe and well tolerated. In patients requiring opioid analgesia, SC morphine plus rHuPH20 provides pharmacokinetic characteristics that are superior to those of SC morphine alone. These positive results warrant further studies on analgesic efficacy of morphine delivered with rHuPH20.
    Journal of pain and symptom management 10/2009; 38(5):663-72. DOI:10.1016/j.jpainsymman.2009.03.009 · 2.42 Impact Factor
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    ABSTRACT: Neuropathic pain is a considerable burden that affects activities of daily living. The management of neuropathic pain can be challenging because of multiple etiologies and complex manifestations. Ziconotide is a nonopioid intrathecal (IT) analgesic option for patients with neuropathic pain refractory to conventional treatments. The objective of this article is to review the published literature on ziconotide for the treatment of neuropathic pain. Relevant publications were identified through searches of all years of 6 databases, which included PubMed, EMBASE, and CINAHL. Search terms used were ziconotide, SNX-111, MVIIA, Prialt, and neuropathic pain. Publications were included if ziconotide was intrathecally administered (either alone or in combination with other IT agents) to treat neuropathic pain of any etiology and if pain assessment was an outcome measure. Data extracted included study design, IT drug doses, pain outcome measures, and adverse events (AEs). Twenty-eight articles met the inclusion criteria: 5 were preclinical studies and 23 were clinical studies. In the preclinical studies, ziconotide demonstrated antiallodynic effects on neuropathic pain. Data from double-blind, placebo-controlled (DBPC) trials indicated that patients with neuropathic pain reported a mean percent improvement in pain score with ziconotide monotherapy that ranged from 15.7% to 31.6%. A low starting dose and slow titration of ziconotide resulted in an improved safety profile in the aforementioned trials. Common AEs associated with ziconotide include nausea and/or vomiting, dizziness, confusion, urinary retention, and somnolence. Evidence from DBPC trials, open-label studies, case series, and case studies suggests that ziconotide, as either monotherapy or in combination with other IT drugs, is a potential therapeutic option for patients with refractory neuropathic pain. Additional studies are needed to establish the long-term efficacy and safety of ziconotide for neuropathic pain.
    Pain Practice 09/2009; 9(5):327-37. DOI:10.1111/j.1533-2500.2009.00303.x · 2.18 Impact Factor
  • Mark S. Wallace, John Thipphawong
    PM&R 09/2009; 1(9):S220-S221. DOI:10.1016/j.pmrj.2009.08.291 · 1.66 Impact Factor
  • Bone 07/2009; 45. DOI:10.1016/j.bone.2009.04.150 · 4.46 Impact Factor
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    ABSTRACT: Prospective in vivo experimental animal model. To determine the effect of intra-arterial injection of the steroids commonly used for transforaminal epidurals on the central nervous system. And to determine if all of the steroids have the same effect. SUMMARY OF BACKGROUND DATA.: Transforaminal epidural steroid injection is commonly employed to treat radicular pain. This approach is associated with complications, including stroke and death. While the mechanism is unknown, the leading hypothesis is that intravascular injection of particulate steroids leads to microembolization. To characterize the nature of steroid induced injury, a rodent model was employed. The internal carotid artery was dissected and its branches ligated. The external carotid artery was ligated, mobilized, cannulated, and injectate administered. Five solutions were tested: Depo-Medrol (N = 11), Depo-Medrol carrier (N = 6), Solu-Medrol (N = 6), Decadron (N = 8), and normal saline (N = 7). Drugs, in volume of 50 microL, were injected into the ICA via the ECA cannula at 25 microL/min. The extent of central nervous system injury was evaluated by analysis of coronal sections of the brain. Cerebral hemorrhage occurred in test subjects with the following frequency: 8 of 11 in the Depo-Medrol group, 7 of 8 in the Solu-Medrol group, and 3 of 6 in the Depo-Medrol carrier group; no lesions were identified in the Decadron or saline groups (P < 0.01). Evan's blue dye leakage was detected in the Depo-Medrol and Solu-Medrol groups, but not the Decadron or saline groups. This study presents the first in vivo evaluation of intra-arterial steroid injection. Data demonstrate Depo-Medrol, as well as its nonparticulate carrier, and Solu-Medrol can produce significant injury to the blood-brain barrier when injected intra-arterially. These results demonstrate that injury is produced not only by particulate obstruction of the cerebral microvasculature, but also by toxicity of the carrier or steroid (methylprednisolone).
    Spine 07/2009; 34(16):1638-43. DOI:10.1097/BRS.0b013e3181ac0018 · 2.45 Impact Factor
  • Bone 07/2009; 45. DOI:10.1016/j.bone.2009.04.052 · 4.46 Impact Factor
  • Tobias Moeller-Bertram, Mark S. Wallace
    Current Pain and Headache Reports 06/2009; 13(3):179-180. DOI:10.1007/s11916-009-0030-0 · 2.26 Impact Factor
  • M. Wallace, J. Thipphawong
    Journal of Pain 04/2009; 10(4). DOI:10.1016/j.jpain.2009.01.208 · 4.22 Impact Factor
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    ABSTRACT: To determine the efficacy and safety of a gastric-retentive, extended-release gabapentin (gabapentin ER) taken once or twice daily for treatment of postherpetic neuralgia. Using an enrichment design, a randomized, double-blind, placebo-controlled study was conducted in 158 patients who had experienced pain for at least 3 months after healing of acute herpes zoster skin rash and who had a baseline average daily pain (ADP) score of > or =4 on a 0 to 10 Numerical Rating Scale. Patients received gabapentin ER either once daily (1800 mg PM) or twice daily (600 mg AM, 1200 mg PM) or placebo for 4 weeks. Efficacy measures included changes from baseline to end point in ADP score and average daily sleep interference score. Mean (SEM) changes for ADP score were -1.93 (0.28), -2.24 (0.29), and -1.29 (0.29) in the gabapentin ER once daily, twice daily, and placebo groups, respectively (P=0.089 and 0.014 for gabapentin ER once daily and twice daily, respectively, vs. placebo), with 25.5%, 28.8%, and 11.8% of patients, respectively, reporting > or =50% decrease from baseline in ADP score. Mean (SEM) changes in sleep interference scores were -1.94 (0.30), -2.28 (0.30), and -1.16 (0.30), respectively (P=0.048 and 0.006 for gabapentin ER once daily and twice daily, respectively, vs. placebo). Common adverse events in the gabapentin ER once daily, twice daily, and placebo groups, respectively, were dizziness (22.2%, 11.3%, and 9.8%) and somnolence (9.3%, 7.5%, and 7.8%). Gabapentin ER administered twice daily is effective and safe for the treatment of pain associated with postherpetic neuralgia.
    The Clinical journal of pain 01/2009; 25(3):185-92. DOI:10.1097/AJP.0b013e3181934276 · 2.70 Impact Factor

Publication Stats

5k Citations
514.26 Total Impact Points


  • 1994–2015
    • University of California, San Diego
      • Department of Anesthesiology
      San Diego, California, United States
  • 2012
    • Johns Hopkins University
      • Department of Anesthesiology and Critical Care Medicine
      Baltimore, Maryland, United States
    • VA San Diego Healthcare System
      San Diego, California, United States
  • 2010
    • Beth Israel Medical Center
      • Department of Pain Medicine and Palliative Care
      New York City, New York, United States
    • Cephalon Inc.
      Malvern, Pennsylvania, United States
  • 2009
    • Swedish Medical Center Seattle
      Seattle, Washington, United States
    • University of Wisconsin, Madison
      • Department of Neurology
      Madison, MS, United States
  • 2008
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
    • La Jolla Pharmaceutical
      San Diego, California, United States
  • 2004
    • University of Florida
      Gainesville, Florida, United States
  • 2000
    • University of San Diego
      San Diego, California, United States