Catherine Munera

Cara Therapeutics (United States)

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Warren Wen

Cara Therapeutics (United States)

Frédérique Menzaghi

Cara Therapeutics (United States)

Robert H. Spencer

Cara Therapeutics (United States)

Steven R. Ripa

Fulcrum Therapeutics (United States)

Kristine Nograles

Cara Therapeutics (United States)

Mark Lebwohl

Icahn School of Medicine at Mount Sinai

S. Ripa

Purdue Pharma (United States)

Brian Kim

Icahn School of Medicine at Mount Sinai

Joana Gonçalves

University of Coimbra

Shau Yu Lynch

AbbVie (United States)

Cooperative Institutions

University of Florida

117

Columbus Oncology and Hematology Associates

109

Reckitt Benckiser (United States)

National Institutes of Health Clinical Center

Purdue Pharma (United States)

Harvard University

Case Western Reserve University

Icahn School of Medicine at Mount Sinai

University of Pennsylvania

RELX Group (United States)

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Oral Difelikefalin Reduces Pruritus in Atopic Dermatitis

SKIN The Journal of Cutaneous Medicine (2021)

Brian Kim Masato Tamari Lydia Zamidar Kristine Nograles Catherine Munera

N/A

10.25251/skin.5.supp.76

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Citations (1)

Application site adverse events of Butrans™ (buprenorphine) transdermal system

Journal of Pain (2011)

Warren Wen Stephen M. Lynch Catherine Munera S. Ripa Howard Maibach

Discontinuation

Erythema

Injection site

Tolerability

10.1016/j.jpain.2011.02.253

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Citations (2)

Efficacy and Safety of the Seven-Day Buprenorphine Transdermal System in Opioid-Naïve Patients with Moderate to Severe Chronic Low Back Pain: An Enriched, Randomized, Double-Blind, Placebo-Controlled Study

Journal of Pain and Symptom Management (2011)

Deborah J. Steiner Steve Sitar Warren Wen Gosford Sawyerr Catherine Munera

This article presents the results of a pivotal Phase 3 study that assesses a new treatment for the management of chronic low back pain: a transdermal patch containing the opioid buprenorphine. In this randomized, placebo-controlled study with an enriched enrollment design, the buprenorphine transdermal system (BTDS) was found to be efficacious and generally well tolerated.This enriched, multicenter, randomized, double-blind study evaluated the efficacy, tolerability, and safety of BTDS in opioid-naïve patients who had moderate to severe chronic low back pain.Patients who tolerated and responded to BTDS (10 or 20 mcg/hour) during an open-label run-in period were randomized to continue BTDS 10 or 20 mcg/hour or receive matching placebo. The primary outcome was "average pain over the last 24 hours" at the end of the 12-week double-blind phase, collected on an 11-point scale (0=no pain, 10=pain as bad as you can imagine). Sleep disturbance (Medical Outcomes Study subscale) and total number of supplemental analgesic tablets used were secondary efficacy variables.Fifty-three percent of patients receiving open-label BTDS (541 of 1024) were randomized to receive BTDS (n=257) or placebo (n=284). Patients receiving BTDS reported statistically significantly lower pain scores at Week 12 compared with placebo (least square mean treatment difference: -0.58, P=0.010). Sensitivity analyses of the primary efficacy variable and results of the analysis of secondary efficacy variables supported the efficacy of BTDS relative to placebo. During the double-blind phase, the incidence of treatment-emergent adverse events was 55% for the BTDS treatment group and 52% for the placebo treatment group. Laboratory, vital sign, and electrocardiogram evaluations did not reveal unanticipated safety findings.BTDS was efficacious in the treatment of opioid-naïve patients with moderate to severe chronic low back pain. Most treatment-emergent adverse events observed were consistent with those associated with the use of opioid agonists and transdermal patches.

Tolerability

10.1016/j.jpainsymman.2011.04.006

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A Phase 2 Study of Oral Difelikefalin for Moderate-to-Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

SKIN The Journal of Cutaneous Medicine (2022)

Brian Kim Robert Bissonnette Kristine Nograles Catherine Munera Nilam C. Shah

N/A

10.25251/skin.6.supp.104

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Citations (1)

A trial comparing low-dose, short-course ciprofloxacin and standard 7 day therapy with co-trimoxazole or nitrofurantoin in the treatment of uncomplicated urinary tract infection

Journal of Antimicrobial Chemotherapy (1999)

Abdollah Iravani Ira Klimberg Caesar Briefer Catherine Munera Steven F. Kowalsky

Abstract The study was undertaken to compare the safety and efficacy of twice-daily ciprofloxacin for 3 days with standard 7 day therapy with either co-trimoxazole or nitrofurantoin in the treatment of women with acute, uncomplicated urinary tract infections (UTI). This multicentre, prospective, randomized, double-blind trial compared oral ciprofloxacin (100 mg bd) for 3 days with co-trimoxazole (160/800 mg bd) or nitrofurantoin (100 mg bd) for 7 days. Bacteriological and clinical evaluations were performed at study entry, during therapy and 4-10 days and 4-6 weeks after the completion of therapy. The primary efficacy parameter was eradication of the causative organism 4- 10 days following treatment. Of 713 women enrolled and evaluable for safety, 521 were evaluable for efficacy (168 ciprofloxacin, 174 co-trimoxazole, 179 nitrofurantoin). Escherichia coli (83%) was the most frequently isolated pathogen in all treatment groups. Bacteriological eradication was reported in 88% of ciprofloxacin patients, 93% of co-trimoxazole patients and 86% of nitrofurantoin patients. At the 4-6 week follow-up, ciprofloxacin had statistically significantly higher eradication rates (91%) than co-trimoxazole (79%; 95% confidence limit (CL) = −20.6%, −3.9%) and nitrofurantoin (82%; 95% CL = −17.1%, −0.9%). Clinical resolution 4- 10 days after therapy and at the 4- 6 week follow-up was similar among the three treatment groups. The overall incidence of treatment-emergent adverse events was not significantly different (P= 0.093) among the three drug regimens, althousgh co-trimoxazole was associated with a greater number of adverse events than ciprofloxacin (P ≤0.05). Ciprofloxacin also caused fewer episodes of nausea than either of the other agents (P ≤0.01).

Nitrofurantoin

10.1093/jac/43.suppl_1.67

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Citations (89)

Dose‐Dependent Flux of Buprenorphine Following Transdermal Administration in Healthy Subjects

The Journal of Clinical Pharmacology (2016)

Yi Wang Alessandra Cipriano Catherine Munera Stephen Harris

Buprenorphine transdermal delivery system (BTDS) applied once every 7 days is indicated for the management of pain that is severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The 7-day flux of buprenorphine from BTDS to systemic circulation was investigated in a phase 1, 2-period crossover study with 3 randomized groups of healthy subjects receiving BTDS containing buprenorphine 5, 10, or 20 mg for 7 days preceded or followed by intravenous buprenorphine infusion (25 μg/h for 24 hours). Residual and absolute bioavailability methods were used to estimate 7-day flux of buprenorphine. Following BTDS administration, mean area under the curve of buprenorphine increased proportionally (12.6, 24.3, and 51.1 ng/[mL · h]), maximum mean plasma concentration rose with increasing dose (176, 191, and 471 pg/mL), and absolute bioavailability was 14% to 16%. Mean residual amount of buprenorphine in the BTDS after 7-day application was 4.50, 8.57, and 17.1 mg. Flux of buprenorphine was approximately 5, 10, and 20 μg/h for BTDS containing 5, 10, and 20 mg buprenorphine, respectively. BTDS was safe and well tolerated following a single 7-day application in healthy subjects. The results of this study demonstrated dose-dependent flux of buprenorphine delivered via transdermal system.

10.1002/jcph.718

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Citations (8)

Butrans™ (buprenorphine) Transdermal System Improves the Quality of Sleep in Patients with Moderate-To-Severe Chronic Pain

Journal of the American Medical Directors Association (2011)

Warren Wen Warren Wen Shau Yu Lynch Catherine Munera Ruth Swanton

Sleep

10.1016/j.jamda.2010.12.027

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Citations (0)

Identifying optimal dosage regimes under safety constraints: An application to long term opioid treatment of chronic pain

Statistics in Medicine (2018)

Eric B. Laber Fan Wu Catherine Munera Ilya Lipkovich Salvatore V. Colucci

There is growing interest and investment in precision medicine as a means to provide the best possible health care. A treatment regime formalizes precision medicine as a sequence of decision rules, one per clinical intervention period, that specify if, when and how current treatment should be adjusted in response to a patient's evolving health status. It is standard to define a regime as optimal if, when applied to a population of interest, it maximizes the mean of some desirable clinical outcome, such as efficacy. However, in many clinical settings, a high‐quality treatment regime must balance multiple competing outcomes; eg, when a high dose is associated with substantial symptom reduction but a greater risk of an adverse event. We consider the problem of estimating the most efficacious treatment regime subject to constraints on the risk of adverse events. We combine nonparametric Q‐learning with policy‐search to estimate a high‐quality yet parsimonious treatment regime. This estimator applies to both observational and randomized data, as well as settings with variable, outcome‐dependent follow‐up, mixed treatment types, and multiple time points. This work is motivated by and framed in the context of dosing for chronic pain; however, the proposed framework can be applied generally to estimate a treatment regime which maximizes the mean of one primary outcome subject to constraints on one or more secondary outcomes. We illustrate the proposed method using data pooled from 5 open‐label flexible dosing clinical trials for chronic pain.

Average treatment effect

10.1002/sim.7566

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Citations (18)

A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression

Pain Practice (2015)

Aaron Yarlas K. Miller Warren Wen Shau Yu Lynch Catherine Munera

Chronic pain (CP) patients with depression typically exhibit worse post-treatment outcomes than nondepressed CP patients. The cause is often assumed to reflect a differential response to treatment, neglecting other potential explanations, such as the continuation of differences in pretreatment outcomes. This post hoc analysis examines whether worse post-treatment outcomes for depressed patients with chronic low back pain (CLBP) are driven by reduced treatment efficacy.Data were from opioid-naïve adult patients with moderate-to-severe CLBP who participated in a randomized, placebo-controlled, double-blind clinical trial of Butrans(®) (buprenorphine) Transdermal System (BTDS) for pain relief. Depression screening was based on baseline SF-36v2 Mental Health subscale scores. Patient-reported measures of pain severity, pain interference, quality of life, sleep problems, and functional disability were administered at screening and during the study. Differential treatment efficacy for each outcome was examined using analysis of covariance models that included interaction terms between treatment arm and depression status.At baseline, patients classified as depressed showed greater pain interference, lower quality of life, more sleep problems, and greater functional disability than nondepressed patients; the two groups did not differ in pain severity. No statistically significant interactions between treatment arm and depression status were observed. The direction of improvement post-treatment favored the depressed group on nine of seventeen outcomes.Results do not support a differential response to BTDS treatment between depressed and nondepressed CLBP patients across a variety of patient-reported outcomes. These findings raise the question of whether depressed mood actually moderates the effectiveness of treatment in CP patients.

Depression

10.1111/papr.12298

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Citations (6)

43755 Rapid Reduction and Strict Complete Response in Itch With Oral Difelikefalin in Subjects With Notalgia Paresthetica and Moderate-to-Severe Pruritus

Journal of the American Academy of Dermatology (2023)

Mark Lebwohl Brian Kim Javier Alonso‐Llamazares Zoe Diana Draelos Kristine Nograles

10.1016/j.jaad.2023.07.862

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Citations (0)