Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that its lidocaine patch, ZTlido, met primary and secondary endpoints in a pivotal study comparing the patch to Endo Pharmaceutical‘s Lidoderm patch. The data will be used to resubmit a new drug application to the FDA in mid-2017, the Malvern, Pa.-based company said.
The clinical trial evaluated Scilex’s 1.8% lidocaine patch to the 5.0% Lidoderm patch. The primary endpoint established comparative pharmacokinetics, while the secondary endpoint demonstrated bioequivalence between the 2 patches. ZTlido’s anhydrous patch contains only 36 mg of lidocaine, while Lidoderm holds 700 mg per patch.
The company is developing ZTlido to treat a severe neuropathic pain condition called post-herpetic neuralgia. Cancer patients, the elderly population, and HIV/AIDs patients are at the highest risk of developing PHN.
“We are very satisfied with the data from this pivotal study, and are now closer to meeting our objective with ZTlido, which is to provide an ultra-thin and pliable patch for patients to better manage the debilitating pain associated with PHN. Our market research shows that these attributes are key to enhancing patient compliance and potentially, enabling better treatment outcomes,” Scilex president Anthony Mack said in prepared remarks.
“Sorrento is pleased with the outcome of this study and believes, based on recent discussions with the FDA, that the data will be supportive of Scilex’s resubmission of its NDA to the FDA. In addition, the positive data is a key validation of Scilex’s novel technologies and ability to swiftly address important, unmet needs to ameliorate the treatment of acute and chronic conditions. This was a key impetus for Sorrento’s acquisition of Scilex last month. We are confident that given its potential commercial differentiation, ZTlido will be able to gain a meaningful share of the $700 million lidocaine patch market,” Sorrento president & CEO Henry Ji added.
SRNE shares were trading at $5.55 apiece in afternoon activity, up 7.8%.