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Lyrica® CR (pregabalin extended-release) - New formulation approved

by
Optum Workers' Comp
| Oct 24, 2017

Pfizer Inc. recently announced the approval of Lyrica CR (pregabalin) extended-release tablets by the U.S. Food and Drug Administration (FDA). Lyrica CR has been approved for once-daily therapy for the treatment of neuropathic (nerve) pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN), known as nerve pain caused by shingles. 

In comparison, immediate-release pregabalin (Lyrica®) may be dosed two or three times daily and is FDA approved for treatment of neuropathic pain associated with DPN, PHN and spinal cord injury, as well as fibromyalgia and adjunctive therapy in adults with partial onset seizure disorder. In contrast, Lyrica CR did not receive FDA approval for management of fibromyalgia or as adjunctive therapy in adults with partial onset seizure disorder.

Lyrica and Lyrica CR are both considered Schedule V controlled substances, meaning there exists a low potential for abuse and mild euphoria at higher doses. Lyrica CR will be available in the following strengths: 82.5 mg, 165 mg, and 330 mg. Pfizer plans to launch Lyrica CR in January 2018.  Pfizer’s patent for Lyrica is expected to expire in December 2018 meaning generic pregabalin may become available in 2019.

References:
Pfizer News, U.S. FDA Approves Lyrica® CR (pregabalin) Extended-Release Tablets C-V.  Available at https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lyrica_cr_pregabalin_extended_release_tablets_cv





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