(RTTNews) - Scilex Holding Company (SCLX), a revenue-generating company focused on non-opioid pain management, on Tuesday, announced that it will file a Supplemental New Drug Application with the FDA for ELYXYB, seeking approval for acute pain indication.
ELYXYB is a first-line non-opioid therapeutic alternative to opioids and acetaminophen, aiming to reduce reliance on opioids for managing acute pain.
The filing is based on positive results from a randomized, double-blind, placebo-controlled clinical trial of 120 patients who underwent dental surgery.
ELYXYB showed a significant reduction in pain intensity, with all doses (62.5, 125, and 250 mg) outperforming placebo.
ELYXYB also demonstrated superior results in treatment satisfaction, pain relief speed, and reduced rescue medication use.
ELYXYB is formulated using a self-microemulsifying drug delivery system or SMEDDS, which enhances its bioavailability, making it more effective than traditional celecoxib capsules. The new indication for acute pain builds on ELYXYB's existing FDA approval for acute migraine treatment.
Elyxyb, developed by Dr. Reddy's Laboratories, Inc., received its initial FDA approval in May 2020, for the acute treatment of migraine with or without aura in adults.
Scilex acquired the rights to Elyxyb in the U.S. and Canada in February 2023.
SCLX closed Friday's (Jan.17 2025) trading at $0.44 down 4.30%. In premarket trading Tuesday, the stock is up 4.67% at $0.47.
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