News & Media

    36th Annual J.P. Morgan Healthcare Conference 
    Charleston Laboratories, Inc. Reacquires Rights to Novel Investigational Treatment CL-108, for Acute Pain and Opioid-Induced Nausea and Vomiting 
    Patients Treating Flares of Osteoarthritis with CL-108 Experienced Improvements in Activities of Daily Living Under Actual Conditions of Use 

    Abstract not published in abstract book

    What is the likelihood of opioid-induced nausea and vomiting (OINV) in patients who by history are assumed to be not at risk of developing OINV? 

    Abstract not published in abstract book

    Prophylactic Antiemetic Use Reduces Opioid Induced Nausea and Vomiting and Improves Patient Recovery in the Outpatient Setting 

    Oak Y, Gregorian R, Kwong W, Kane A, Zou P, Marrett E. J Manag Care Pharm. 2017:23:S91.

    Charleston Laboratories, Inc. Announces Senior Global Regulatory Hire 
    Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for New Drug Application for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets for Oral Use 
    Charleston Laboratories, Inc. Announces Formation of U.S. Commercial Subsidiary 
    Charleston Laboratories, Inc. Expands Senior Management Team with Two Key Appointments in Core Business Areas of Medical & Commercialization 
    Health Care Utilization and Costs Associated with Nausea and Vomiting in Patients Receiving Oral Immediate-Release Opioids for Outpatient Acute Pain Management 

    Marrett E, Kwong WJ, Frech F, Qian C. Pain Ther. 2016;5:215-226.

    Clinically Meaningful Pain Relief in Patients with Moderate to Severe Acute Pain Treated with CL-108 

    Published abstract book not available

    The incidence of opioid-induced nausea and vomiting (OINV) in patients who by history are assumed to be not at risk of developing OINV 

    Published abstract book not available

    Patients Treating Flares of Osteoarthritis with CL-108 Experienced Improvements in Activities of Daily Living Under Actual Conditions of Use 

    Published abstract book not available

    Results from Using the Nausea Intensity Scale: The Severity Of Nausea is Significantly Reduced by CL-108 Compared with a Standard Hydrocodone/ Acetaminophen Analgesic When Used to Treat Moderate-To-Severe Pain 

    Published abstract book not available

    No evidence of increased abuse potential of CL-108, a bi-layered tablet containing hydrocodone/acetaminophen/promethazine, in recreational opioid users 

    Shram M, Levy-Cooperman N, Webster L. (2016) PAINWeek Abstract Book 2016, Postgraduate Medicine, 128:sup2, 84

    Actual-Use Study of CL-108 for the treatment of flares of osteoarthritis of the knee or hip 

    Aazami H, Glover RM, Kivitz AJ, Oliver D, Ricci DR, Surowitz R, Schachtel B. (2016) PAINWeek Abstract Book 2016, Postgraduate Medicine, 128:sup2, 79.

    The Efficacy of CL-108 in Preventing Opioid-Induced Nausea and Vomiting (OINV) 

    Daniels SE, Richardson SF, Patrick K, Royall SP, Schachtel E, Lorton MB, Zhang B, Cho S, Schachtel BP. (2016) PAINWeek Abstract Book 2016, Postgraduate Medicine, 128:sup2, 79.

    The Impact of Nausea on Pain and its Relief 

    Bender R, Schachtel B, Revicki D, Rentz A, Kwong J, Marrett E. (2016) PAINWeek Abstract Book 2016, Postgraduate Medicine, 128:sup2, 9.

    Use of the Qualities of Pain Index (QPI) to demonstrate beneficial effects on affective and sensory qualities of pain 

    Schachtel B, Hersh E, Zuniga J, Daniels S, Muse D, Patrick K, Oreadi D, Bennett J, Schachtel E, Papas A. (2016) PAINWeek Abstract Book 2016, Postgraduate Medicine, 128:sup2, 104.

    Patients Treated with CL-108 Over a 5-day Post-Operative Period Use Less Antiemetic Medication for Opioid-Induced Nausea and Vomiting (OINV) than Patients Treated with Standard Hydrocodone/Acetaminophen 

    Hersh EV, Schachtel B. (2016) PAINWeek Abstract Book 2016, Postgraduate Medicine, 128:sup2, 41.

    Objective evidence of the efficacy of CL-108 compared to standard hydrocodone 7.5 mg/ acetaminophen 325 mg in preventing Opioid-Induced Nausea and Vomiting (OINV) 

    Hersh EV, Schachtel B, Kozarek WJ, Schachtel E. (2016) PAINWeek Abstract Book 2016, Postgraduate Medicine, 128:sup2, 80.

    Safety and Effectiveness of CL-108 for the Treatment of Moderate-to-Severe Pain Associated with Flares of Osteoarthritis of the Knee or Hip 

    Schachtel B, Marino M, Lazar J, Aazami H, Burnette M, Kivitiz A, Lewis K, Lorton MB, McIlwain H, Munir M, Oliver D, Poland S, Ricci D, Schachtel E, Tseytlin L. Pain Med. 2016;17(2):429.

    CL-108 Reduces the Use of Rescue Antiemetic Medications for Opioid-Induced Nausea and Vomiting 

    Hersh E, Marino M, Schachtel B. Pain Med. 2016;17(2):423.

    Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108 
    No evidence of increased abuse potential of CL-108 a bilayered tablet containing hydrocodone/ acetaminophen/promethazine, in recreational opioid users 

    Levy-Cooperman N, Shram M, Webster LR.

    Charleston Laboratories, Inc. Announces Presentations at the Annual Scientific Meeting of the American Pain Society 
    Healthcare Costs Associated with Nausea and Vomiting in Patients Receiving Oral Immediate-Release Opioids for the Management of Acute Pain in the Outpatient Setting 

    Marrett E, Frech F, Zhang Q, Qian C. JMCP. 2016;22:S114.

    Opioid-Induced Nausea and Vomiting (OINV) in Post-Operative Patients: A Comparison of CL-108 to Hydrocodone 7.5 mg/Acetaminophen 325 mg 

    Richardson SF, Patrick K, Daniels SE, Royall SP, Schachtel E, Zhang B, Marino M, Schachtel B. J Pain. 2016;17(4):S83.

    Efficacy of CL-108 compared to hydrocodone 7.5 mg/acetaminophen 325 mg in preventing vomiting and the use of anti-emetics, Opioid-Induced Nausea and Vomiting (OINV) 

    Hersh E, Schachtel B, Kozarek W, E Schachtel, Marino M. J Pain. 2016;17(4):S82

    Governor Scott Announces Charleston Laboratories, Inc. Expansion Will Create 25 New Jobs 
    The Business Development Board of Palm Beach Plays Key Role in Charleston Laboratories, Inc. Expansion 
    Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce Phase 3 Study of CL-108 Met Primary Endpoints 
    What is the incidence of opioid-induced nausea and vomiting in patients who do not have immediate post-operative nausea or vomiting? 

    Schachtel B, Marino M, Kozarek W, Schachtel E, Hersh E. (2015) PAINWeek Abstract Book 2015, Postgraduate Medicine, 127:sup1, S83.

    Raymond A. Dionne D.D.S., Ph.D Joins Charleston Laboratories, Inc Scientific Advisory Board 
    Charleston Laboratories, Inc. Announces Completion of a Second Phase 3 Clinical Trial on its Lead Product, CL-108, and the Appointment of Dr. Raymond Dionne to its Scientific Advisory Board 
    Charleston Laboratories, Inc. Initiates Patient Enrollment in a Phase 1 Study of Charleston’s Second Product, CL-H1T 
    Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce Three Poster Presentations at American Pain Society Annual Meeting 
    Charleston Laboratories, Inc. Completes Patient Enrollment in a Phase
    NEED WORD DOC: The incidence of opioid-induced nausea and vomiting (OINV) in patients with a history that is only suggestive of developing OINV 
    Opioid-Induced Nausea and Vomiting (OINV) in patients without immediate post-op nausea/vomiting 

    Hersh E, Kozarek W, Marino M, Schachtel B. Opioid-Induced Nausea and Vomiting (OINV) in patients without immediate post-op nausea/vomiting. J Pain. 2015;16(4):S80.

    Affective and sensory qualities of pain complement evaluative measures of opioid analgesia: results from the Qualities of Dental Pain Index (QDPI) 

    Schachtel B, Hersh E, Papas A, Daniels S, Muse D, Patrick K, Bennett J, Schachtel E, Marino M, Zuniga J. J Pain. 2015;16(4):S7.

    What is the likelihood of opioid-induced nausea and vomiting (OINV) in patients with a history that is only suggestive of OINV? 

    Hersh E, Papas A, Zuniga J, Daniels S, Muse D, Patrick K, Bennett J, Schachtel E, Marino M, Schachtel B. J Pain. 2015;16(4):S16.

    Charleston Laboratories, Inc. & Daiichi Sankyo, Inc. Announce Completion of a Pharmacokinetics Study on CL-108 
    Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Initiate Two Phase 3 Clinical Trials on Charleston’s Lead Product, CL-108 
    Prescription for Success 
    Charleston Laboratories, Inc. Announces Key Clinical Updates for Novel Drugs 
    Safety and efficacy of CL-108 for moderate-to-severe acute pain with reduction of opioid-induced nausea and vomiting 

    Hersh E, Schachtel B, Daniels S, Muse D, Patrick K, Zuniga J, Bennett J, Schachtel E, Papas A. Poster presented at: Pain Week 2014; September 2-6, 2014; Las Vegas, NV.

    Charleston Laboratories and Daiichi Sankyo Announce Collaboration to Develop and Commercialize Novel, Fixed-Dose Combination Hydrocodone Products for Pain and Opioid-Induced Nausea and Vomiting (OINV) in the US 
    Gary A. Peltz, M.D. Joins Charleston Laboratories, Inc Scientific Advisory Board 
    Charleston Laboratories, Inc., Bolsters Senior Management Team 
    Charleston Laboratories, Inc. Announces Publication of Abstract for CL-108 Phase 3 Study at APS 2014 
    Demonstration of the safety and efficacy of CL-108 for moderate-to-severe pain with reduction of opioid-induced nausea and vomiting 

    Schachtel B, Younes N, Zhou J, Schachtel E, Hersh E. Demonstration of the safety and efficacy of CL-108 for moderate-to-severe pain with reduction of opioid-induced nausea and vomiting. J Pain 2014;15(4): S81.

    Strong Efficacy Data Prompt Charleston Laboratories to Halt Phase 3 Study of CL-108 in Patients with Moderate to Severe Acute Pain 
    Charleston Laboratories, Inc. Announces Research Collaboration with Stanford University 
    Charleston Laboratories, Inc Successfully Completes Pre-IND Meeting on New Migraine Treatment 
    FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment 
    Charleston Laboratories, Inc submitted a request with the U.S. Food and Drug Administration (FDA) for a Pre-Investigational New Drug (Pre-IND) meeting regarding the development of CL-H1T. 
    Robert H. Dworkin, Ph.D Joins Charleston Laboratories, Inc Scientific Advisory Board 
    Charleston Laboratories, Inc. Begins Enrollment for CL-108 Phase 3 Clinical Trial 
    31st Annual J.P. Morgan Healthcare Conference 
    Charleston Laboratories, Inc. Appoints Ryan Baker Executive Vice President and Chief Operating Officer 
    Charleston Laboratories, Inc. Appoints Bill Kozarek Ph.D Vice President of Product Development 
    30th Annual J.P. Morgan Healthcare Conference 
    Charleston Laboratories, Inc. Awarded a Qualifying Therapeutic Discovery Project Grant 
    BIO International Convention 2009 
    Charleston Laboratories, Inc. Completes Exploratory Bioequivalence Study of CL-108 
    Charleston Conducts Evaluation of an Opioid Symptoms Questionnaire 
    Charleston Completes Preliminary Research on Nausea-Prone Questionnaire (NPQ) 
    Charleston Completes Preliminary Research on Nausea-Prone Questionnaire (NPQ) 
    Charleston Labs begins Bioequivalence Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CL-108 
    27th Annual J.P. Morgan Healthcare Conference 
    Charleston Labs begins Bioequivalence Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CL-108 
    Charleston Sucessfully Completes Series A Private Placement 
    Charleston Laboratories, Inc. Investigational New Drug CL-108 “Safe to Proceed Testing in Man.” 
    26th Annual J.P. Morgan Healthcare Conference 
    Charleston completes successful Type B, Pre-IND meeting with FDA’s Division of Anesthesia, Analgesia and Rheumatology Products on November 8, 2007, held at FDA’s Silver Spring, Maryland offices. 
    Charleston Laboratories, Inc. Appoints Bernard Schachtel, M.D. Chief Medical Officer 
    Charleston Laboratories, Inc. Appoints John F. Ameling V.P of Regulatory Affairs