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.