Regulatory Affairs

FDA approves Sorrento's non-opioid pain patch for post-herpetic neuralgia

PBR Staff Writer Published 01 March 2018

Sorrento Therapeutics’ subsidiary Scilex Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for non-opioid ZTlido (lidocaine topical system) 1.8% to relieve pain associated with post-herpetic neuralgia (PHN) or post-shingles pain.

ZTlido includes non-aqueous adhesive material containing 1.8% lidocaine, which will be applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner.

The release liner will be pierced in the middle and removed prior to application to the skin.

ZTlido’s anhydrous topical system is based on a new technology, which is designed to achieve better adhesion and drug delivery efficiency.

It is said to require 36 mg/topical system against 700 mg/patch of Lidoderm (lidocaine patch 5%) to achieve the same therapeutic dose of drug

ZTlido adhesion performance was showed in a clinical study with 54 healthy volunteers, of which 47subjects (87%) had adhesion scores of zero and seven (7) subjects (13%) had adhesion scores of one.

In the same study, the 91% (49) of the subjects had a score of zero at the end of the 12-hour administration period.

ZTlido showed superior adhesion to Lidoderm at three hours in a separate phase 1 comparative adhesion study in normal healthy subjects.

Sorrento and Scilex chairman and CEO Henry Ji said: “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 healthcare providers, patients and payers who are looking for an effective and efficient, local pain treatment.

“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.”

Based in San Diego of California, Sorrento is engaged in the development of novel therapies for malignant cancers.