The Food and Drug Administration (FDA) has approved ZTlido (lidocaine topical system; Scilex Pharmaceuticals) for the relief of pain associated with post-herpetic 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 two 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<0.0001) 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.
For more information call (858) 203-4100 or visit SorrentoTherapeutics.com.