Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that it filed a marketing authorization application seeking approval for its ZTlido lidocaine patch. The San Diego, Calif.-based company said it is pursuing a hybrid regulatory pathway with the Medicines and Healthcare Products Regulatory Agency in the U.K., which will serve as the lead review agency. The company also plans […]
Scilex Pharmaceuticals
FDA to review re-submitted application for Sorrento’s lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that the FDA has received the resubmitted version of a new drug application for its lidocaine patch, ZTlido. 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 […]
Sorrento seeks FDA nod for lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) said today that its subsidiary Scilex Pharmaceuticals resubmitted the new drug application for its lidocaine patch, ZTlido, to the FDA. The San Diego, Calif.-based company is developing the drug-device product for the relief of pain associated with post-herpetic neuralgia. “We are excited about the opportunity to bring to the market a product that […]
Scilex touts head-to-head study of lidocaine pain-relief patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals touted data today from a head-to-head clinical adhesion study of its ZTlido lidocaine patch, comparing it to the EU reference product, Versatis. ZTlido is a lidocaine patch in development for the treatment of post-herpetic neuralgia – a severe neuropathic pain condition that affects elderly people and patients who have […]
Scilex touts data for novel lidocaine patch
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 […]
