Posted from: Monday, June 04, 2018 - 10:22 AM - Present

Lyrica Receives Expanded Indication

May 3, 2018 – The U.S. FDA has approved an expanded indication for Lyrica® (pregabalin), manufactured by Pfizer, to be used as an adjunctive treatment for patients four years of age and older who have partial onset seizures.

In a clinical study, patients age four to 17 years who were treated with Lyrica at a dose of either 10mg/kg or 2.5mg/kg daily experienced a reduction in partial onset seizures compared to those who received a placebo. The higher dose of 10mg/kg demonstrated a greater reduction in partial onset seizures, and a higher rate of response. Recommended dosing under the new indication is based on weight and divided across two to three doses daily.

Lyrica was first approved in 2004, and is also indicated for the treatment of fibromyalgia, post herpetic neuralgia (PHN), neuropathic pain associated with diabetic peripheral neuropathy (DPN), and as an adjunctive therapy for adult patients with partial onset seizures, and fibromyalgia.

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.

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.

Last Updated Friday, June 22, 2018 - 11:52 PM.