Scilex Holding, a Subsidiary of Sorrento, Has Received From FDA a sNDA Approval for ZTlido Label Expansion
PALO ALTO, Calif., April 09, 2021 (GLOBE NEWSWIRE) -- Scilex Holding (“Scilex”), an over 99% owned subsidiary of Sorrento Therapeutics (NASDAQ: SRNE, “Sorrento”), has received a supplemental new
drug application (sNDA) approval from the FDA for ZTlido to make efficacy labeling change with clinical data.
ZTlido is the only lidocaine topical system that has been studied under the water stress conditions, and now has FDA label reflecting its use while showering, swimming and bathing. It gives polymer-based ZTlido a competitive edge as other systems, especially water-based or hydrogel-based formulations, cannot be used when wet and must be removed prior to water exposure.
In the previous clinical trial (NCT04784728), a randomized, crossover, adhesion performance and pharmacokinetic study under conditions of water exposure in healthy subjects, Scilex had demonstrated that upon immersing the lidocaine topical system 1.8% (ZTlido) in water, wet topical systems can be successfully reapplied, if necessary, and remain adhered for up to the labeled administration period of 12 hours. The trial showed that the topical system may be used while showering and that this does not increase lidocaine plasma levels. The topical systems were well-tolerated under all conditions and the dermal irritation profile was benign.
"We are very pleased with the trial outcome and labeling revision that attests to characteristics of ZTlido superior to other topical systems, to give patients a more reliable and uninterrupted drug delivery to alleviate pain associated with post-herpetic neuralgia," said Dmitri Lissin, MD, Chief Medical Officer of Scilex.
About Sorrento Therapeutics
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB library"), clinical stage immuno-cellular therapies ("CAR-T", "DAR-T"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir", “Seprehvec”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP, ACE-MAB, COVI-MAB, COVI-GUARD, COVI-SHIELD, COVI-AMG and T-VIVA-19; and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRACE.