Products

Cyclobenzaprine ER (once daily)

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The first and only once-a-day formulation of cyclobenzaprine, the most-prescribed muscle relaxant in the U.S.1


Therapeutic Category Pain
Indication
  • Skeletal muscle relaxant: relief of muscle spasm associated with acute and painful musculoskeletal conditions
Available Dosage Strength(s)
  • 15 mg
  • 30 mg
Product Description
  • Novel, once daily formulation of the skeletal muscle relaxant, cyclobenzaprine hydrochloride
Eurand Technology
Data
  • Bioequivalent to 3-times-daily dosing: Once daily dose is similar in total drug exposure over 24 hours compared with the reference product dosed every 8 hours
  • Excellent safety profile during phase I studies (no SAEs)
  • Somnolence rates of 1% (15 mg) and 2% percent (30 mg) in phase III studies
  • Predictable and expected adverse events as seen with clinical and real-world use of standard cyclobenzaprine
Advantages
  • Once daily dosing regimen facilitates patient compliance to therapy2
  • Improved side-effect profile with very low rates of somnolence

Marketing Authorizations are available in a number of EU major markets. For more information on available MAs, please contact Eurand at partners@eurand.com.

Cyclobenzaprine Single-day, crossover pharmacokinetic study: Mean cyclobenzaprine concentration over time (N-36).

Recent Updates

Eurand has partnered with countries worldwide to commercialize, license, and supply cyclobenzaprine ER:

  • U.S.: Marketed by Cephalon as AMRIX® (Cyclobenzaprine Hydrochloride Extended-Release Capsules)
  • South Korea: Marketed by Daewoong Pharmaceuticals Co., Ltd.as Bonelax®
  • Turkey: Nobel Ilac A.S.
  • Israel: PharmaSwiss SA
  • South Africa: Adcock Ingram

AMRIX is a registered trademark of Cephalon in the U.S.

This information is provided solely for the purpose of the evaluation of business opportunities by potential collaboration partners. The information is based on currently existing data and marketing authorizations in a number of jurisdictions and should not be assumed to be approved by regulatory authorities in any individual country. Consumers should consult with their individual physician for product information and should not rely upon any information provided here.

1IMS MAT Aug 2008.
2 Kardas P. Comparison of patient compliance with once daily and twice-daily antibiotic regimens in respiratory tract infections: results of a randomized trial. J Antimicrob Chemother. 2007;59:531-536.

Pain Products

More Information

For more information, contact Eurand at partners@eurand.com or +1-267-759-9340

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