The company resubmitted its application for ZTlido to the FDA last year after it was rejected by the U.S. regulatory agency in 2016.
“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,” chairman & CEO Henry Ji said in prepared remarks.
“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. As demonstrated by the NDA approval for ZTlido, our team successfully executed on our development plan for the product and now, looks forward to executing on our commercial and strategic alliance plans as well.”
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 last year, 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. After 12 hours, ZTlido had a mean adhesion score of 5.006 and Versatis had a mean adhesion score of 2.268.
SRNE shares were trading at $9.05 apiece in mid-afternoon activity today, up +7.2%.