Pivotal bioequivalence trial of Ztilido vs Lidoderm in volunteers.
Phase of Trial: Phase I
Latest Information Update: 05 Dec 2016
At a glance
- Drugs Lidocaine (Primary)
- Indications Postherpetic neuralgia
- Focus Pharmacokinetics; Registrational
- Sponsors Scilex Pharmaceuticals
- 05 Dec 2016 According to Sorrento Therapeutics media release, the full data will be resubmitted to the U.S. Food and Drug Administration (FDA) as part of the new drug application (NDA) in mid-2017.
- 05 Dec 2016 Results published in the Sorrento Therapeutics Media Release.
- 05 Dec 2016 Primary endpoint has been met, according to Sorrento Therapeutics media release.