Scilex Receives Fast Track Designation for Back Pain Combo Product
Scilex, a Sorrento Therapeutics subsidiary, has received Fast Track designation from the FDA for its investigational drug and device product candidate SP-103.
The company is jockeying for SP-103 to receive FDA approval for use in patients with acute lower back pain. If approved, the product would be the first lidocaine topical product for this indication, said Scilex.
There are currently no approved pharmaceutical treatments specifically indicated for the treatment of acute lower back pain, the company said.
Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
SCILEX HOLDING COMPANY
SCILEX HOLDING COMPANY (“Scilex”), a majority-owned subsidiary of Sorrento, is dedicated to the development and commercialization of pain management products. The company’s lead product ZTlido® (lidocaine topical system 1.8%), is a branded prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain.
Scilex’s SP-102 (10 mg dexamethasone sodium phosphate gel), or SEMDEXA™, for the treatment of Lumbar Radicular Pain is in the process of completing a Phase III clinical trial. The company expects SP-102 to be the first FDA approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica, with the potential to replace 10 to 11 million off-label epidural steroid injections administered each year in the US.
September 12, 2022
