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.