ZTlido Approved to Treat Post-Herpetic Neuralgia
February 28, 2018 – The U.S. FDA has approved ZTlido™ (lidocaine topical system 1.8%), manufactured by Scilex Pharmaceutical, to relieve pain caused by post-herpetic neuralgia (PHN).
Post-herpetic neuralgia is a common source of pain for patients who have had shingles in the past, and for which lidocaine patches can be prescribed for relief. The FDA has reported that adhesion is the most widely cited quality issue in transdermal drug delivery patches such as lidocaine patches.
ZTlido differs from other lidocaine patches in its adhesive. According to Scilex, ZTlido addresses this problem through proprietary technology that offers better skin contact and efficient delivery of lidocaine over the course of 12 hours of wear. ZTlido is considered bioequivalent to other lidocaine patches, including Lidoderm® (lidocaine) Patch 5%.
IQVIA reports that, in 2017, over 100 million prescription lidocaine patches were sold in the U.S. Pricing for ZTlido has not yet been announced, though the manufacturer plans to launch the product before the close 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.