We use cookies to provide you with a better experience. By clicking the Accept button, you are agreeing to our use of cookies in accordance with our Privacy Policy.
  • Patient Resources
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
    • Glossary
  • Professional Resources
    • Research Center Profiles
    • Industry Provider Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
  • About Us
  • Contact Us
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Horizant (gabapentin enacarbil)

  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Horizant (gabapentin enacarbil)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Horizant is an extended-release formulation of gabapentin enacarbil, a prodrug of gabapentin. The precise mechanism by which gabapentin is efficacious in RLS is unknown. Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but has no effect on GABA binding, uptake, or degradation.

    Horizant is specifically indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults.

    Horizant is supplied as an extended release tablet for oral administration. The recommended dosage is 600 mg once daily taken with food at about 5 PM.

    Clinical Results

    FDA Approval
    The FDA approval of Horizant was based on two 12-week clinical studies in approximately 400 adults with RLS. The subjects were required to have a total score of ≥15 on the International Restless Legs Syndrome (IRLS) Rating Scale at baseline. In Study 1 the subjects received the 1,200mg of Horizant or placebo taken once daily at about 5 PM with food. In Study 2 the subjects received 600 mg of Horizant, 1,200 mg of Horizant or placebo taken once daily at about 5 PM with food. Efficacy was evaluated using the IRLS Rating Scale and Clinical Global Impression of Improvement (CGI-I) score. Statistically significant differences (P<0.05) between the treatment groups receiving 600 and 1,200 mg of Horizant and the group receiving placebo were observed at Week 12 for both the mean change from baseline in the IRLS Scale total score and the proportion of responders (much improved) or (very much improved) on the CGI-I Scale.

    Side Effects

    Adverse events associated with the use of Horizant may include, but are not limited to, the following:

    • somnolence/sedation
    • dizziness
    • headache

    Mechanism of Action

    Horizant is an extended-release formulation of gabapentin enacarbil, a prodrug of gabapentin. The precise mechanism by which gabapentin is efficacious in RLS is unknown. Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but has no effect on GABA binding, uptake, or degradation.

    Literature References

    Ellenbogen AL, Thein SG, Winslow DH, Becker PM, Tolson JM, Lassauzet ML, Chen D A 52-week study of gabapentin enacarbil in restless legs syndrome. Clinical Neuropharmacology 2011 Jan-Feb;34(1):8-16

    Bogan RK, Bornemann MA, Kushida CA, Trân PV, Barrett RW; XP060 Study Group Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clinic Proceedings 2010 Jun;85(6):512-21

    Walters AS, Ondo WG, Kushida CA, Becker PM, Ellenbogen AL, Canafax DM, Barrett RW; XP045 Study Group. Gabapentin enacarbil in restless legs syndrome: a phase 2b, 2-week, randomized, double-blind, placebo-controlled trial. Clinical Neuropharmacology 2009 Nov-Dec;32(6):311-20

    Cundy KC, Sastry S, Luo W, Zou J, Moors TL, Canafax DM Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. Journal of Clinical Pharmacology 2008 Dec;48(12):1378-88

    Additional Information

    For additional information regarding Horizant or restless legs syndrome, please visit the Horizant web page.

    Approval Date: 2011-04-01
    Date Created: 2011-04-26 12:00:00
    Company Name: GlaxoSmithKline
    Back to Listings

    Upcoming Events

    • 16Dec

      Master the Regulatory Pathway for Cell & Gene Therapy Submissions: Strategies for Successful BLAs

    Featured Products

    • Regenerative-medicine-steps-to-accelerate-development-pdf

      Regenerative Medicine: Steps to Accelerate Development — PDF

    • Clinical-trial-agreements-a-guide-to-key-words-and-phrases-pdf

      Clinical Trial Agreements: A Guide to Key Words and Phrases — PDF

    Featured Stories

    • Patient-phsyician-consultation

      Giving Patients Back Their Voice in Clinical Trials

    • Ich_logo

      ICH Overhauls 22-Year-Old Clinical Studies Guideline

    • Survey_chart2019

      Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed

    New!

    2019 Site Survey Reports

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing