AMRIX® (Cyclobenzaprine Hydrochloride
Extended-Release Capsules)
| Drug | Cyclobenzaprine is the most frequently prescribed drug for muscle relaxation in the United States. AMRIX is indicated for short-term relief of muscle spasm as an adjunct to rest and physical therapy. |
| Unmet Need | Modified-release formulation of cyclobenzaprine with reduced side effect |
| Challenges | Develop a more convenient (once-daily administration) dosage form of a leading muscle relaxant drug. (Until the approval of AMRIX in 2007, cyclobenzaprine had to be administered two to three times daily.) |
| Solution | Diffucaps® multiparticulate bead system enabled the development of a formulation with an initial release of drug for quick onset-of-action, and also for sustained release to maintain consistence plasma levels throughout the day. Proprietary polymers layered onto Diffucaps beads containing the drug reduced fluctuations in drug plasma levels associated with immediate-release dosing. |
| Result | Safety and efficacy of AMRIX were demonstrated in two phase III trials, and daytime drowsiness associated with the modified-release product was less than that with immediate release cyclobenzaprine taken three times daily. |
| Product Achieved | AMRIX - marketed by Cephalon in the U.S. Bonelax - marketed by Daewoong Pharmaceuticals, Inc. in South Korea Product has also been licensed for commercialization in South Africa, Israel, and Turkey. |
AMRIX is available in two dose-proportional strengths – 15 and 30 mg capsules. This illustrates an advantage of the Diffucaps technology - multiple product strengths can be readily developed by using differing amount of drug-layered beads contained in the final capsule dosage form.
AMRIX® is a registered trademark of Cephalon, Inc., or its affiliates
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