Sorrento Therapeutics' Pain Subsidiary, SCILEX Pharmaceuticals, Announces Positive Data from Head to Head Adhesion Study with its Lead Product, ZTlido™
- ZTlido™ demonstrated superior adhesion as compared to the reference product in the EU
- The study results complement a previous clinical adhesion study using the FDA recommended 5-point scale
- 505(b)(2) NDA resubmission and MAA filing in the EU are expected in 2H 2017
SAN DIEGO, June 14, 2017 /PRNewswire/ -- SCILEX Pharmaceuticals Inc. ("SCILEX"), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") today announced that its lead investigational product, ZTlido™ (lidocaine medicated plaster 1.8%), has demonstrated superior adhesion versus the EU reference product Versatis® (medicated plaster 5%) during a recently completed comparative adhesion performance study. The study was performed to support the market authorization application (MAA) for ZTlido™ in the EU. These data complement a previous clinical adhesion study performed to support the new drug application (NDA) submission for ZTlido™ in the US, where greater than 90% of the subjects demonstrated greater than 90% adhesion over the 12-hour administration period using the FDA recommended 5-point scale.
(PRNewsfoto/Sorrento Therapeutics, Inc.)...
ZTlido™ is a next-generation non-opioid, lidocaine patch currently in development for the treatment of post-herpetic neuralgia ("PHN"), a severe neuropathic pain condition. The elderly population, individuals that have suffered a Shingles infection, HIV/AIDS and cancer patients are at the highest risk of contracting PHN. As previously reported, the comparative pharmacokinetics and bioequivalence between ZTlido™ and Lidoderm® and ZTlido™ and Versatis® were demonstrated in its pivotal clinical studies. ZTlido™'s anhydrous patch is based on a novel and proprietary technology that contains only 36 mg of lidocaine versus Lidoderm® and Versatis®, which both hold 700 mg of lidocaine per patch. SCILEX plans to resubmit the NDA for ZTlido™ to the FDA and the MAA to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and other member states (EU countries) in the second half of 2017.
ZTlido™ was specifically designed to have superior adhesion as compared to the US and EU reference products Lidoderm®/ Versatis® in recognition that adhesion is critical to the safety, efficacy and quality of a patch or medicated plaster pharmaceutical product. This is especially the case for patch or medicated plaster systems such as ZTlido™ and Lidoderm®/Versatis® where the drug is contained in the adhesive and must be in contact with the skin to deliver the drug. In the article Aspect of Adhesives in Transdermal Drug Delivery Systems, the authors state "Complete skin contact over the entire delivery surface for the entire label exposal period is essential. In other words, the quality of contact between patch and skin is directly reflected in the consistency of drug delivery."1
"We are pleased to report our noteworthy data. We believe that the ability of ZTlido™ to outperform Versatis® in this head to head study will translate into better patient compliance and provide us with an important clinical advantage. I look forward to moving ZTlido™ closer to commercialization in the US and the EU," said Anthony Mack, President of SCILEX Pharmaceuticals.
The head-to-head adhesion study was designed and carried out as an open label, three-period, single-patch application, adhesion performance study of ZTlido™ versus Versatis® in compliance with Appendix II of the European Medicines Agency (EMA) Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms. The EMA guideline requires that ZTlido™, at a minimum, demonstrate statistically significant non-inferior mean adhesion at each of the pre-determined time points (the primary endpoint).
The study was completed in 44 healthy volunteers. Volunteers were assessed for adhesion at 0, 3, 6, 9, and 12 hours (the labeled administration period). Adhesion was scored using the EMA scale ranging from a score of 6 being greater than 95% adhesion and a score of 0 (>70% adhesion; significant adhesion failure). ZTlido™ demonstrated superior adhesion as compared to Versatis® with a mean adhesion score of 5.35 versus 3.59 for Versatis® (p<0.001). At the end of the 12-hour dosing period, ZTlido™ had a mean adhesion score of 5.006 while Versatis® mean adhesion was 2.268 as graphically presented below (p<0.001).
Two (4.5%) subjects had complete detachments of Versatis® with one subject's detachment occurring between 9 and 12 hours and the other prior to 3 hours. There were no detachments observed in the ZTlido™ cohort. Additionally, dermal irritation was assessed using the 7-point dermal irritation scale after patch removal, and there was no statistically significant difference of the mean irritation scores between ZTlido™ and Versatis® (p=0.1656). Neither product was observed to have a dermal irritation score above 1 (i.e., minimal erythema, barely perceptible). The mean irritation score decreased for both products 2 hours after removal.
"Sorrento continues to be pleased with the outcome of this data and the results of the recently released pivotal PK studies," said Dr. Henry Ji, President and Chief Executive Officer of Sorrento. "The US and European Union markets represent attractive market opportunities for ZTlido™ and we will continue to support product development efforts for this groundbreaking asset."
About SCILEX Pharmaceuticals Inc.
SCILEX, located in San Diego, California, a majority-owned subsidiary of Sorrento Therapeutics, leverages on its core, proprietary technologies to responsibly develop next generation, branded pharmaceutical products to better manage critical conditions and maximize the quality of life of patients and healthcare providers. We are uncompromising in our focus to become the global pharmaceutical leader committed to social, environmental, economic, and ethical responsibility. Leveraging on our global partnerships, we deliver the next generation of trailblazing products that are responsible by design. The Company's lead product under development, ZTlido™ (lidocaine patch 1.8%), is a branded lidocaine patch formulation is being developed for the treatment of relieving the pain of post-herpetic neuralgia, also referred to as after-shingles pain. Lidocaine medicated plaster 1.8% and lidocaine patch 1.8% are the same product, but have different dosage form designations in the US ("patch") and EU ("medicated plaster"). For more information visit www.scilexpharma.com.
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for pain management, cancer, inflammation and autoimmune diseases. Sorrento's lead product candidates include late-stage pain drugs, therapeutic antibodies for cancer, inflammation and autoimmune diseases, as well as clinical stage immune-cellular therapies targeting solid tumors. For more information visit www.sorrentotherapeutics.com.
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex's and Sorrento's beliefs regarding the study data and results, Scilex's and Sorrento's beliefs that the study supports a NDA re-submission and MAA submission, the timing of the re-submission of an NDA and submission of the MAA for ZTlido, the ability for ZTlido to achieve better patient compliance and clinical advantage, the commercialization of ZTlido, SCILEX' prospects and Sorrento's ability to accelerate the development of its lead programs, particularly in oncology, in the clinic. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: that ZTlido™ may not meet all endpoints of the clinical study, that the data may not support an NDA resubmission and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2016, as amended as amended, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ZTlido™ is a trademark owned by SCILEX Pharmaceuticals Inc. A proprietary name review by the FDA is planned.
Lidoderm® is a registered trademark of Hind Health Care, Inc. Versatis® is a registered trademark of Grunenthal. All other trademarks and trade names are the property of their respective owners.
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved.
1 Banerjee S., Chattopadhyay P, Ghosh A, Datta P, Veer V, Aspect of adhesives in transdermal drug delivery systems, International Journal of Adhesion & Adhesives 50 (2014) 70-84.
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SOURCE Sorrento Therapeutics, Inc.