The San Diego, Calif.-based company is developing the drug-device product for the relief of pain associated with post-herpetic neuralgia.
The FDA said it is slated to finish reviewing the company’s NDA by February 28th next year. SRNE shares were trading at $1.85 apiece today in mid-afternoon activity, up 1.4%.
If the product wins approval by the FDA, the company has said it could be ready for its U.S. commercial launch in 2018. Sorrento also reportedly plans to submit a marketing authorization application for ZTlido in Europe in the fourth quarter of this year.
Sorrento’s anhydrous patch contains just 36 milligrams of lidocaine, compared to reference products Lidoderm and Versatis, which each have 700 milligrams of the painkiller.
In June, the company touted data from a head-to-head clinical adhesion study of its ZTlido lidocaine patch, comparing it to Versatis.
The study’s primary endpoint was to demonstrate statistically significant non-inferior mean adhesion at each of the pre-determined time points. In 44 healthy volunteers, the researchers assessed adhesion at 0, 3, 6, 9 and 12 hours. Adhesion was scored using an EMA scale ranging from 6, being greater than 95% adhesion, and a score of 0, meaning significant adhesion failure.
ZTlido had superior adhesion compared to Versatis, with mean adhesion scores of 5.35 and 3.59 respectively. At the end of the 12-hour time period, ZTlido had a mean adhesion score of 5.006 and Versatis had a mean adhesion score of 2.268.
Two participants had complete detachment with Versatis, but there were no detachments in the ZTlido group. There was also no statistically significant difference in the mean dermal irritation scores between the 2 products.