Speciality Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Education Dialogues
    • Business Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Speciality Medical Dialogues
    • Editorial
    • News
        • Anesthesiology
        • Cancer
        • Cardiac Sciences
        • Critical Care
        • Dentistry
        • Dermatology
        • Diabetes and Endo
        • Diagnostics
        • ENT
        • Featured Research
        • Gastroenterology
        • Geriatrics
        • Medicine
        • Nephrology
        • Neurosciences
        • Nursing
        • Obs and Gynae
        • Ophthalmology
        • Orthopaedics
        • Paediatrics
        • Parmedics
        • Pharmacy
        • Psychiatry
        • Pulmonology
        • Radiology
        • Surgery
        • Urology
    • Practice Guidelines
        • Anesthesiology Guidelines
        • Cancer Guidelines
        • Cardiac Sciences Guidelines
        • Critical Care Guidelines
        • Dentistry Guidelines
        • Dermatology Guidelines
        • Diabetes and Endo Guidelines
        • Diagnostics Guidelines
        • ENT Guidelines
        • Featured Practice Guidelines
        • Gastroenterology Guidelines
        • Geriatrics Guidelines
        • Medicine Guidelines
        • Nephrology Guidelines
        • Neurosciences Guidelines
        • Obs and Gynae Guidelines
        • Ophthalmology Guidelines
        • Orthopaedics Guidelines
        • Paediatrics Guidelines
        • Psychiatry Guidelines
        • Pulmonology Guidelines
        • Radiology Guidelines
        • Surgery Guidelines
        • Urology Guidelines
    LoginRegister
    Speciality Medical Dialogues
    LoginRegister
    • Home
    • Editorial
    • News
      • Anesthesiology
      • Cancer
      • Cardiac Sciences
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endo
      • Diagnostics
      • ENT
      • Featured Research
      • Gastroenterology
      • Geriatrics
      • Medicine
      • Nephrology
      • Neurosciences
      • Nursing
      • Obs and Gynae
      • Ophthalmology
      • Orthopaedics
      • Paediatrics
      • Parmedics
      • Pharmacy
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
    • Practice Guidelines
      • Anesthesiology Guidelines
      • Cancer Guidelines
      • Cardiac Sciences Guidelines
      • Critical Care Guidelines
      • Dentistry Guidelines
      • Dermatology Guidelines
      • Diabetes and Endo Guidelines
      • Diagnostics Guidelines
      • ENT Guidelines
      • Featured Practice Guidelines
      • Gastroenterology Guidelines
      • Geriatrics Guidelines
      • Medicine Guidelines
      • Nephrology Guidelines
      • Neurosciences Guidelines
      • Obs and Gynae Guidelines
      • Ophthalmology Guidelines
      • Orthopaedics Guidelines
      • Paediatrics Guidelines
      • Psychiatry Guidelines
      • Pulmonology Guidelines
      • Radiology Guidelines
      • Surgery Guidelines
      • Urology Guidelines
    • Home
    • Latest News
    • Investigational Tx...

    Investigational Tx Shows Promise in Chronic Low Back Pain

    Written by Vinay Singh singh Published On 2018-09-24T19:15:49+05:30  |  Updated On 24 Sept 2018 7:15 PM IST
    Investigational Tx Shows Promise in Chronic Low Back Pain

    Positive top-line results were announced for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid therapy. The study met its primary efficacy endpoint of Average Pain Intensity (API), demonstrating that patients with CLBP receiving treatment with CAM2038 experienced a statistically significant reduction in pain compared with placebo. Furthermore, the key secondary endpoint of Worst Pain Intensity also demonstrated statistical significance.


    The investigational drug CAM2038 (buprenorphine), currently under review is a buprenorphine weekly and monthly subcutaneous depot injection for the treatment of moderate to severe opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for individualized treatment from initiation and stabilization to longer-term maintenance therapy.


    The preliminary findings come from the multicenter, double-blind, randomized withdrawal, placebo-controlled Phase 3 HS-16-555 trial(N=340), which enrolled patients who had been treated with opioids for moderate-to-severe CLBP for a minimum of 3 months prior to trial screening. The patients were randomized to receive CAM2038 50mg/mL once weekly at doses of 8mg, 12mg, 16mg, 24mg, or 32mg; CAM2038 356mg/mL once monthly at doses of 64mg, 96mg, or 128mg; or placebo.


    Read Also: Adding Chiropractic to Usual Care Beneficial for Low Back Pain



    The primary endpoint of change in Average Pain Intensity (API) from baseline to week 12 was achieved by the CAM2038 group, who experienced a statistically significant reduction in pain vs the placebo group. A secondary endpoint of Worst Pain Intensity (WPI) was also statistically significantly reduced in the treatment group compared to placebo at week 12.


    The safety profile observed with CAM2038 was favorable and consistent with previous studies with CAM2038 as well as the known safety profile of buprenorphine.


    CAM2038 provides a slow release of the drug over time, through a proprietary technology known as FluidCrystal®, and is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional.


    The next generation proprietary FluidCrystal® Injection Depot Technology used in the subcutaneous injection of CAM2038 includes a lipid-based liquid with a dissolved active ingredient. Upon injection and contact with fluids in the tissue, the lipid solution transforms into a crystalline gel, which encapsulates the active ingredient, allowing for a slow release of the drug over time.


    The long-term safety of CAM2038 is being evaluated in a 52-week open-label extension study, in which patients are either continuing from the randomized efficacy portion of the study or were enrolled directly in the open-label extension study phase.


    buprenorphineCAM2038chronicDrugFluidCrystainjectioninvestigationallowopioidPainpositive
    Source : press release

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Vinay Singh singh
    Vinay Singh singh
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 12 Oct 2022 7:06 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok