Extended Release Lyrica Approved
October 11, 2017 – The U.S. FDA has approved Lyrica® CR (pregabalin) extended-release tablets to manage pain associated with diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN). Recommended dosing for Lyrica CR is 165mg once per day following an evening meal. Patients may take a higher dose of Lyrica CR if needed, with the maximum dose dependent on the patient’s diagnosis. To treat DPN, patients may take up to 330mg per day if necessary; for PHN, the dosage may be increased to up to 660mg per day. Recommended dosing for standard Lyrica for the same conditions is two to three times daily, with dosage strengths dependent on the patient’s diagnosis and other factors. Both Lyrica and Lyrica CR require adjusted dosing for patients who have reduced renal function.
Like Lyrica, Lyrica CR is considered a C-V controlled substance. Unlike Lyrica, Lyrica CR is not approved for the treatment of fibromyalgia or seizures. Lyrica CR will be available in 82.5mg, 165mg, and 330mg tablets upon launch, which is expected in January of 2018.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.