Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

FDA Approves Horizant To Treat Restless Legs Syndrome

April 7, 2011 By Bio-Medicine.Org

SILVER SPRING, Md., April 7, 2011 /PRNewswire-USNewswire/ — On
April 6, the U.S. Food and Drug Administration approved Horizant
Extended Release Tablets (gabapentin enacarbil), a once-daily
treatment for moderate-to-severe restless legs syndrome (RLS).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

RLS is a disorder that causes a strong urge to move the legs.
This urge often occurs with unpleasant feelings in the legs. People
who have RLS describe feeling pulling, itching, tingling, burning,
or aching in their legs, and moving the legs temporarily relieves
these feelings. The urge to move often happens when a person is
inactive, and the symptoms typically are worse in the evening and
early morning.

“People with restless legs syndrome can experience considerable
distress from their symptoms,” said Russell Katz, M.D., director of
the Division of Neurology Products in the FDA’s Center for Drug
Evaluation and Research. “Horizant provides significant help in
treating these symptoms.”  

The effectiveness of Horizant was studied in two 12-week
clinical trials in adults. The trials showed that people taking the
medication had an improvement in their RLS symptoms, compared with
people taking an inactive pill (placebo).

Horizant will be dispensed with an FDA-approved Medication Guide
that explains the drug’s uses and risks. Horizant may cause
drowsiness and dizziness and can impair a person’s ability to drive
or operate complex machinery.

Horizant contains gabapentin enacarbil that becomes gabapentin,
a drug used to treat seizures in people with epilepsy, when
absorbed into the body. All drugs used to treat epilepsy carry
warnings that they may cause suicidal thoughts and actions in a
small number of people. Horizant will have the same warning.

Horizant was developed by GlaxoSmithKline of Research Triangle
Park, N.C., and Xenoport of Santa Clara, Calif.

For information:

National Institute

‘/>”/>

SOURCE

Related Articles Read More >

Blackrock's Utah array is a miniature array of electrodes for sensing brain signals
Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials
DeepWell Digital Therapeutics Mike Wilson Ryan Douglas
How DeepWell is developing video games as tools for treating medical conditions
A woman with a small, handheld device in her lap with tubes that look like earphones plugged into her ears.
Ear-puffing device for migraine treatment wins FDA breakthrough designation
Abbott
Abbott launches upgraded digital health app for neurostimulation

DeviceTalks Weekly.

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech