MarkBertramSostekMDAGAF, FACG

Gastroenterology • Wilmington, DE

Esophagus Disease, Gastrointestinal Cancer, Gastrointestinal Functional & Motility Disorders

Executive Director, Clinical research

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Office
1800 Concord Pike
C4C-725
Wilmington, DE 19850
Phone+1 302-885-9052
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Education & Training

University of Florida Shands HospitalTraining, Antroduodenal and small bowel manometry , 1997 - 1997
GastroenterologyFellowship, Lahey Clinic, 1991 - 1993
UCLA David Geffen School of Medicine/UCLA Medical CenterInternship, Internal Medicine, 1986 - 1989
Tufts University School of MedicineClass of 1986, MD, Alpha Omega Alpha; Hewlett Packard Award
Middlebury CollegeBachelor of Arts, 1976 - 1980

Certifications & Licensure

CA State Medical License 1987 - Present
PA State Medical License 1998 - 2024
MA State Medical License 1987 - 2001
American Board of Internal Medicine Internal Medicine

Awards, Honors, & Recognition

Fellow (AGAF) American Gastroenterological Association, 2006

Clinical Trials

An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium Start of enrollment: 2006 Oct 01
Completed
Phase 4
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC) Start of enrollment: 2007 Dec 01
Completed
Phase 2
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib Start of enrollment: 2008 Jul 01
Completed
Phase 1
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E Start of enrollment: 2008 Sep 01
Completed
Phase 1
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E Start of enrollment: 2009 May 01
Completed
Phase 1
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation Start of enrollment: 2011 Mar 01
Completed
Phase 3
Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects Start of enrollment: 2011 Mar 01
Completed
Phase 1
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation Start of enrollment: 2011 Mar 01
Completed
Phase 3
A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects Start of enrollment: 2011 Apr 01
Completed
Phase 1
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation Start of enrollment: 2011 Apr 01
Completed
Phase 3
Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118 Start of enrollment: 2011 Jun 01
Completed
Phase 1
Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 Start of enrollment: 2012 Feb 01
Completed
Phase 1
Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118 Start of enrollment: 2012 Mar 01
Completed
Phase 1
Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118 Start of enrollment: 2012 Mar 01
Completed
Phase 1
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients Start of enrollment: 2014 Nov 01
Completed
Phase 1
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Publications & Presentations

PubMed

9 citations
Treatment with Naloxegol Versus Placebo: Pain Assessment in Patients with Noncancer Pain and Opioid-Induced Constipation.
Lynn R. Webster, Ulysses Diva, Raj Tummala, Mark Sostek> ;Pain Practice. 2018 Apr 1
10 citations
Cardiovascular Safety of the Selective μ-Opioid Receptor Antagonist Naloxegol: A Novel Therapy for Opioid-Induced Constipation.
William B. White, Peter R. Kowey, Ulysses Diva, Mark Sostek, Raj Tummala> ;Journal of Cardiovascular Pharmacology and Therapeutics. 2018 Mar 4
30 citations
Pharmacologic Profile of Naloxegol, a Peripherally Acting µ-Opioid Receptor Antagonist, for the Treatment of Opioid-Induced Constipation.
Eike Floettmann, Khanh Bui, Mark Sostek, Kemal Payza, Michael A. Eldon> ;The Journal of Pharmacology and Experimental Therapeutics. 2017 Mar 23
14 citations
When People with Opioid-Induced Constipation Speak: A Patient Survey.
Robert S. Epstein, J. Russell Teagarden, Ali Cimen, Mark Sostek, Tehseen Salimi> ;Advances in Therapy. 2017 Feb 8
9 citations
Translating Clinical Findings into the Patient's Perspective: Post-hoc Pooled Analysis of Bowel Movement Changes as a Predictor of Improvement in Patients' Opioid-indu...
Karin S. Coyne, Jiat-Ling Poon, Christine Thompson, Yiqun Hu, Catherine Datto, Mark Sostek> ;Clinical Therapeutics. 2017 Jan 1
15 citations
Effects of CYP3A Modulators on the Pharmacokinetics of Naloxegol
Khanh Bui, Diansong Zhou, Mark Sostek, Fahua She, Nidal Al-Huniti> ;Journal of Clinical Pharmacology. 2016 Aug 1
8 citations
Population Exposure-Response Modeling of Naloxegol in Patients With Noncancer-Related Pain and Opioid-Induced Constipation.
Nidal Al-Huniti, JC Nielsen, MM Hutmacher, Jaakko Lappalainen, K Cantagallo, Mark Sostek> ;CPT. 2016 Jul 1
31 citations
Simulation and Prediction of the Drug‐Drug Interaction Potential of Naloxegol by Physiologically Based Pharmacokinetic Modeling
Diansong Zhou, Khanh Bui, Mark Sostek, Nidal Al-Huniti> ;CPT. 2016 May 1
18 citations
The effect of quinidine, a strong P-glycoprotein inhibitor, on the pharmacokinetics and central nervous system distribution of naloxegol.
Khanh Bui, Fahua She, Diansong Zhou, Kathleen Butler, Nidal Al-Huniti, Mark Sostek> ;Journal of Clinical Pharmacology. 2016 Apr 1
21 citations
Population pharmacokinetics of naloxegol in a population of 1247 healthy subjects and patients
Nidal Al-Huniti, S. Chapel, Hongmei Xu, Khanh Bui, Mark Sostek> ;British Journal of Clinical Pharmacology. 2016 Jan 1
17 citations
Safety, tolerability, pharmacokinetics, and pharmacodynamic effects of naloxegol at peripheral and central nervous system receptors in healthy male subjects: A single ...
Michael A. Eldon, Alan R. Kugler, Robert A. Medve, Khanh Bui, Kathleen Butler, Mark Sostek> ;Clinical Pharmacology in Drug Development. 2015 Nov 1
8 citations
Safety, tolerability, and pharmacokinetics of multiple ascending doses of naloxegol
Michael A. Eldon, Alan R. Kugler, Robert A. Medve, Khanh Bui, Kathleen Butler, Mark Sostek> ;Clinical Pharmacology in Drug Development. 2015 Nov 1
12 citations
Absorption, distribution, metabolism, and excretion of [14C]-labeled naloxegol in healthy subjects.
Khanh Bui, Fahua She, Michael Hutchison, Åsa Brunnström, Mark Sostek> ;International Journal of Clinical Pharmacology and Therapeutics. 2015 Oct 1
36 citations
Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response
Jan Tack, Jaakko Lappalainen, Ulysses Diva, Raj Tummala, Mark Sostek> ;United European Gastroenterology Journal. 2015 Sep 7
32 citations
Treatment patterns, healthcare utilization, and costs of chronic opioid treatment for non-cancer pain in the United States.
David M. Kern, Siting Zhou, Soheil Chavoshi, Ozgur Tunceli, Mark Sostek, Joseph Singer, Robert J. LoCasale> ;The American Journal of Managed Care. 2015 Mar 1
27 citations
The effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegol.
Khanh Bui, Fahua She, Mark Sostek> ;Journal of Clinical Pharmacology. 2014 Dec 1
30 citations
The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol
Khanh Bui, Fahua She, Mark Sostek> ;Journal of Clinical Pharmacology. 2014 Dec 1
14 citations
Patient Preferences for Change in Symptoms Associated with Opioid-Induced Constipation
Robert Epstein, Ali Cimen, Hannah Benenson, Ronald E. Aubert, Mona Khalid, Mark Sostek, Tehseen Salimi> ;Advances in Therapy. 2014 Nov 21
12 citations
A description of clinical characteristics and treatment patterns observed within prescribed opioid users in Germany and the UK
Pierre Chevalier, Maartje Smulders, Soheil Chavoshi, Mark Sostek, Robert J. LoCasale> ;Pain Management. 2014 Oct 10
83 citations
Randomised clinical trial: the long‐term safety and tolerability of naloxegol in patients with pain and opioid‐induced constipation
Lynn R. Webster, William D. Chey, Jan Tack, Jaakko Lappalainen, Ulysses Diva, Mark Sostek> ;Alimentary Pharmacology & Therapeutics. 2014 Oct 1
11 citations
Description of Cardiovascular Event Rates in Patients Initiating Chronic Opioid Therapy for Noncancer Pain in Observational Cohort Studies in the US, UK, and Germany
Robert J. LoCasale, David M. Kern, Pierre Chevalier, Siting Zhou, Soheil Chavoshi, Mark Sostek> ;Advances in Therapy. 2014 Jul 18
219 citations
Naloxegol for Opioid-Induced Constipation in Patients with Noncancer Pain
William D. Chey, Lynn R. Webster, Mark Sostek, Jaakko Lappalainen, Peter Barker, Jan Tack> ;The New England Journal of Medicine. 2014 Jun 18
25 citations
Evaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers.
Christer Gottfridsson, Glenn Carlson, Jaakko Lappalainen, Mark Sostek> ;Clinical Therapeutics. 2013 Dec 1
92 citations
A phase 2, double-blind, randomized, placebo-controlled, dose-escalation study to evaluate the efficacy, safety, and tolerability of naloxegol in patients with opioid-...
Lynn Webster, Sunita Dhar, Michael A. Eldon, Lorianne K. Masuoka, Jaakko Lappalainen, Mark Sostek> ;Pain. 2013 Sep 1
11 citations
Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium
Laurene Wang-Smith, John Fort, Ying Zhang, Mark Sostek> ;Journal of Clinical Pharmacology. 2012 May 1
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Books/Book Chapters

Chapter: Chapter 63
Sostek MB and Becker JM.WB Saunders Co. Philadelphia
Sostek MBIn The Endocrinologist.. Vol. 3. No. 6, New YorkEdition 2,
Chapter: In Hepatology. Vol. 21. No. 2
Sostek MBElsevier Science., Amsterdam

Abstracts/Posters

Pharmacokinetics and Relative Bioavailability of a Fixed Dose Combination of Enteric Coated Naproxen and Non- Enteric Coated Esomeprazole Magnesium.
Wang-Smith L, Fort J, Zhang Y and Sostek MB, Clin Pharmacol
Relationship between Intragastric Acid Control and Healing Status in the Treatment of Moderate to Severe Erosive Esophagitis.
Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT and Silberg DG, Aliment Pharmacol Therapeutics
Efficacy of esomeprazole 40 mg versus lansoprazole 30 mg for healing moderate to severe erosive esophagitis.
Fennerty MB, Johanson JF, Hwang C, Sostek M, Aliment Pharmacol Ther
Zollinger Ellison Syndrome Succesfully Treated with Esomeprazole.
Sostek MB and Troiano FP, Practical Gastroenterology
High prevalence of chronic gastrointestinal symptoms in a National Guard Unit of Persian Gulf Veterans.
Sostek MB, Jackson S, Linevsky JK, Schimmel EM and Fincke BG, Am. J. Gastro
Multipolar electrocoagulation and injection therapy in the treatment of acute lower gastrointestinal hemorrhage from a rectal ulcer.
Sostek MB and Fine S, American Journal of Gastroenterology
PN400 Significantly Reduces the Incidence of Gastric Ulcers Compared with Enteric Coated Naproxen In Patients Requiring Chronic NSAID Therapy Regardless of Low Dose As...
Goldstein JL, Hochberg MC, Fort JG, Zhang Y and Sostek MB, Arthritis and Rheumatism, e.g. Doximity University
PN400 Significantly Improves Upper Gastrointestinal Tolerability Compared with Enteric Coated Naproxen Alone in Patients Requiring Chronic NSAID Therapy...
Goldstein JL, Hochberg M, Fort JG, Crawley J and Sostek M, American J Gastro, e.g. Doximity University
Naproxen Use Increases the Risk for Complicated Gastroduodenal Ulcers in a Dose Dependent Fashion.
Singh GS, Mannalithara A, Sostek M, Mitha A and Triadafilopoulos, American J Gastro
Positive Association Between Intragastric and Intraesophageal Acid Control and Healing of Los Angeles Grade C and D Erosive Esophagitis: Reslts of a Prospective Contro...
Katz PO, Ginsberg GG, Hoyle P, Sostek MB, Monyak J and Silberg DG, Gastroenterology
Acid output Control with Esomeprazole in Patients with Zollinger Ellison Syndrome and Idiopathic Gastric Hypersecretion: Final 12 Month Results.
Metz DC, Pisegna JR, Rusniewski P, Forsmark CE, Monyak J and Sostek MB., Gastroenterology
Effect of Esomeprazole on Intragastric and Intraoesophageal pH in Patients with Barretts esophagus.
Spechler S, Sharma P, Traxler B, Sostek M and Falk G, Gut
A randomized double blind, placebo-controlled study of acid suppression for the treatment of suspected laryngopharyngeal reflux.
Vaezzi M, Richter J, Stasney RC, Spiegel J, Hwang C, Leathers T and Sostek M, Gastroenterology
Patient reported outcome of heartburn improvement: doubling the proton pump inhibitor (PPI) dose in patients who failed standard dose PPI versus switching to a differe...
Fass R, Thomas S, Traxler B and Sostek M, Gastroenterology
Baseline pH measurements for patients with suspected signs and symptoms of reflux laryngitis.
Richter J, Vaezzi M, Stasney RC, Hwang C, Leathers T, Sostek M and Shaker R, Gastroenterology
Once daily esomeprazole and twice daily lansoprazole in controlling epigatric pain and acid regurgitation in patients with resistant GERD.
Fass R, Traxler BM, Thomas S and Sostek MB, Am J Gastro
Once daily esomeprazole and twice daily lansoprazole for nocturnal heartburn in patients with GERD.
Fass R, Traxler BM, Thomas S and Sostek MB, Am J Gastro
Esomeprazole 40 mg once daily and lansoprazole 30 mg twice daily for heartburn symptoms in patients with resistant GERD.
Fass R, Traxler BM, Thomas S and Sostek MB, Am J Gastro
Esomeprazole provides highly effective acid control that is equally wll maintained during sleep and active periods.
Katz PO, Castell DO, Chen Y and Sostek MB, Am J Gastro
Integrated Gastric Acidity to Evaluate Acid Suppression with PPI therapy: a five way crossover comparison.
Miner PB, Chen Y and Sostek MB, Gastroenterology
Esomeprazole 40 mg provides more effective intragastric acid suppression at steady state than standard doses of other proton pump inhibitors.
Miner PB, Katz PO, Chen Y and Sostek MB, Gastroenterology
Rationale for switching proton pump inhibitor (PPI) therapy: an intraindividual analysis of gastric acid suppression following treatment with different PPIs.
Katz PO, Miner PB, Wilder-Smith CH, Chen Y and Sostek MB, Gastroenterology
The impact of age on the severity of erosive esophagitis in patients with gastroesophageal reflux disease.
Johnson DA, Roach A and Sostek M, Johnson DA, Roach A and Sostek M
Esomeprazole capsule contents suspended in water can be efficiently delivered through nasogastric and gastrostomy tubes.
White CM, Kalus J, Quercia R, Fortier C, Piotrowski A, Roach A and Sostek MB, Am J of Gastroenterol
Safety and Tolerability of Double Dose Esomeprazole (40 mg twice daily).
Richter J, Vaezzi M, Stasney RC, Shaker R, Ianuzzi R, Hwang C, Leathers T and Sostek MB, United European Gastroenterology Week
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Press Mentions

Northside Park Gastroenterology and Endoscopy Center Owner Dr. Michael Sue to Retire — 4 InsightsJanuary 8th, 2018
5 Predictions on GI in 2018January 8th, 2018
OrphoMed Taps GI Expert Dr. Mark Sostek for CMO Position — 3 InsightsJanuary 5th, 2018

Professional Memberships

American Gastroenterological Association - AGA
Fellow