The Food and Drug Administration (FDA) has approved ZTlido (lidocaine topical system; Scilex Pharmaceuticals) for the relief of pain associated with postherpetic neuralgia (PHN).
ZTlido is made of a non-aqueous adhesive material containing 1.8% lidocaine. Compared to Lidoderm (lidocaine patch 5%) which contains 700mg per patch, ZTlido only requires 36mg per topical system to achieve the same therapeutic dose. Pharmacokinetic studies demonstrated bioequivalence between the 2 products and the safety and efficacy of ZTlido was thus extrapolated. A Phase 1 adhesion study (n=44) showed superior adhesion with ZTlido vs Lidoderm at 3 hours (P <.0001) with improvements seen over the 12-hour period.
“Topical lidocaine is an important option for healthcare providers to have in their armamentarium for treating PHN, a difficult-to-treat neuropathic pain,” said Dr Jeff Gudin, Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center. “The Centers for Disease Control and Prevention’s guideline of non-opioid treatments for chronic pain recognizes topical lidocaine as an alternative first-line therapy.”
ZTlido will be available in 1.8% strength patches; product launch is expected sometime in 2018.
Sorrento therapeutics subsidiary, scilex, receives US FDA approval for non-opioidZTlido™ (lidocaine topical system) 1.8% for PHN pain [press release]. San Diego, CA: Sorrento Therapeutics. Published February 28, 2018. Accessed March 1, 2018.
This article originally appeared on MPR