Today, the FDA approved ZTlido (lidocaine topical system) 1.8% for the treatment of pain associated with post-herpetic neuralgia (PHA), which is caused by shingles, according to a press release from Sorrento Therapeutics.
 
Sorrento said its newly-approved product marks significant progress for analgesics because it can deliver pain relief for up to 12 hours, including during exercise.
 
“ZTlido was designed to solve a problem that is commonly reported with transdermal/topical patches: they don’t stay on. Based on the adhesion study results with ZTlido, we believe that ZTlido product will be welcomed by health care providers, patients, and payers who are looking for an effective and efficient, local pain treatment,” Henry Ji, PhD, chairman and CEO of Sorrento and Scilex, said in a press release. “We also intend to explore the expansion of ZTlido into additional indications and the underlining platform technology of ZTlido for other active pharmaceutical ingredients (APIs) and combinations of APIs.”
 
ZTildo is based on new technology that allows for superior adhesion and drug delivery, according to the release.
 
Notably, ZTlido requires a 36-mg/topical system compared with a 700-mg/patch of Lidoderm (lidocaine patch 5%) to achieve the same dose, Sorrento reported.
 
The safety and efficacy profile of the topical system was explored in comparative pharmacokinetic studies. The study results demonstrated bioequivalence between the products, according to the release.
 
The FDA previously reported that adhesion was a significant hurdle for effective transdermal drug delivery. To address this, the manufacturer developed a patch with a goal of maintaining skin contact for 12 hours.
 
Adhesion performance was investigated in a clinical trial of 54 healthy patients. The results showed that there was no patch lift off the skin among 87% of patients over a 12-hour period, according to Sorrento.
 
Another 13% of patients experienced some edges lifting off the skin and no patients had significant patch lift off the skin, according to the release.
 
Another phase 1 clinical trial showed that ZTlido was superior to Lidoderm at 3 hours and over 12 hours in terms of adhesion, Sorrento reported.
 
“Topical lidocaine is an important option for healthcare providers to have in their armamentarium for treating PHN, a difficult-to-treat neuropathic pain,” Jeff Gudin, MD, director, Pain Management and Palliative Care, Englewood Hospital and Medical Center, said in the release. “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 now offers providers and patients this option.”