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Cyclobenzaprine ER (once-daily)

Pain
Amrix

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


Eurand utilizes their proprietary Diffucaps® technology to create a convenient, once-daily extended release formulation of cyclobenzaprine with an improved side effect profile; Eurand’s cyclobenzaprine ER shows lower rates of somnolence, a common side effect of muscle relaxants.

Eurand currently out-licenses cyclobenzaprine ER in several major markets around the world. It is marketed in the U.S. as AMRIX® (Cyclobenzaprine Hydrochloride Extended-Release Capsules) by Cephalon.

Therapeutic Category

Pain

Indication

Skeletal muscle relaxant: relief of muscle spasm associated with acute and painful musculoskeletal conditions

Development Status

Commercialized; Licensing opportunities available

Available Dosage Strength(s)

  • 15 mg
  • 30 mg

Product Description

Novel, once-daily formulation of the skeletal muscle relaxant, cyclobenzaprine hydrochloride

Eurand Technology

Diffucaps® - Customized Drug Release technology

Licensing Opportunities

Eurand is seeking licensing partners in Asia Pacific territories.

Marketing Authorizations are also available in a number of EU major markets.

Cyclobenzaprine ER eliminates the multiple peaks and troughs in daily plasma levels associated with the IR formulation.2


Cyclobenzaprine

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

06/2008

Cyclobenzaprine ER: Development of the First Once-Daily Muscle
Relaxant

By: Troy Harmon, MS, MBA
AMRIX® is the first and only once-daily skeletal muscle relaxant available in the U.S. With the approval and launch of AMRIX®, physicians have the option to prescribe a more convenient dosing regimen for patients. Patients now have a more convenient option for administration of the market-leading muscle relaxant cyclobenzaprine, and may also benefit from a lower incident of somnolence that has been associated with the immediate-release formulation of the drug.

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
  • South America: Tecnofarm SA

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.

For more information on this product, please contact Eurand.

1IMS MAT Aug 2008.
2Adapted from: Darwish et al. Clin Drug Investig. 2008.

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

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