Scilex Holding Company Announces that It Will Be Filing Today of a Supplemental New Drug Application with the FDA for ELYXYB in Acute Pain Indication

Published: 2025-01-22 10:31:32 ET SCLX

PALO ALTO - Scilex Holding Company (Nasdaq: SCLX, 'Scilex' or 'Company'), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease, today announced that it will be filing today of a Supplemental New Drug Application (SNDA) with the FDA for ELYXYB in acute pain indication.

The analgesic efficacy and safety of ELYXYB, a new oral liquid formulation of celecoxib with more rapid absorption than the capsule, were evaluated in the treatment of acute pain in adult patients after dental surgery. In this randomized, double-blind, placebo-controlled, dose-ranging study, 120 otherwise healthy adults who underwent the extraction of bilateral impacted mandibular third molar teeth and experienced moderate to severe pain post-surgery were randomly assigned to receive one dose of either placebo or ELYXYB: 62.5, 125, or 250 mg. All 3 doses of ELYXYB were significantly superior to placebo in SPID6 (summed pain intensity difference over 6 hours). In addition, ELYXYB was generally superior to placebo in other endpoints, including reduction of pain intensity, speed and magnitude of pain relief, treatment satisfaction, and rescue medication use (oxycodone / acetaminophen). ELYXYB was similar to placebo in the incidence of adverse events with no apparent dose-related effects.

'It is very exciting to see the advancement of new effective therapeutic options for acute pain. Opioid-sparing medications are a priority in both non-operative and post-operative pain control. Reducing reliance on opioids with a new rapidly absorbed liquid formulation of celecoxib is very much welcomed. The rapid onset of action and convenience of dosing will significantly improve our armamentarium to provide the best patient care,' said Aakash A. Shah, M.D., physician for NBA team Miami Heat and President of the Medical Staff at Mid-America Surgery Institute.

ELYXYB is formulated using the self-microemulsifying drug delivery system (SMEDDS), which is a clear, thermodynamically stable, oil-in-water emulsion of lipid, solubilized drug, and two surfactants, which spontaneously forms droplets