Scilex Holding Company has announced the submission of a Supplemental New Drug Application (SNDA) to the U.S. Food and Drug Administration (FDA) for ELYXYB, seeking its approval for the treatment of acute pain in adults. ELYXYB, a ready-to-use oral solution of celecoxib, is already FDA-approved for the acute treatment of migraine, with or without aura, in adults. This application aims to broaden its use as a non-opioid alternative for managing acute pain, potentially impacting the approximately 40 million Americans who are prescribed opioids annually for acute pain.
The SNDA is supported by data from a randomized, double-blind, placebo-controlled study involving 120 adults who underwent dental surgery. The study evaluated the analgesic efficacy and safety of ELYXYB in managing acute pain following the extraction of bilateral impacted mandibular third molar teeth. Results indicated that all three tested doses of ELYXYB (62.5 mg, 125 mg, and 250 mg) were significantly superior to placebo in SPID6 (summed pain intensity difference over 6 hours). The treatment was generally well-tolerated, with a similar incidence of adverse events compared to placebo and no evident dose-related effects.
Clinical Trial Results
The clinical trial demonstrated that ELYXYB was superior to placebo in multiple endpoints, including reduction of pain intensity, speed and magnitude of pain relief, treatment satisfaction, and rescue medication use (oxycodone/acetaminophen). These findings suggest that ELYXYB could offer a rapid and effective option for acute pain management.
According to Dr. Aakash A. Shah, physician for the NBA team Miami Heat, the advancement of ELYXYB represents a shift towards opioid-sparing medications, which is important for both non-operative and post-operative pain control. He noted that reducing reliance on opioids with a new, rapidly absorbed liquid formulation of celecoxib is very much welcomed, and the rapid onset of action and convenience of dosing will significantly improve the ability to provide the best patient care.
Addressing the Need for Non-Opioid Alternatives
The filing of the SNDA for ELYXYB aligns with the growing need for non-opioid pain management options. The acute pain market in the U.S. was estimated to be approximately $3 billion in 2021, with a significant portion of patients being prescribed opioids. ELYXYB, with its rapid onset and ready-to-use formulation, aims to provide a therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.
ELYXYB is formulated using a self-microemulsifying drug delivery system (SMEDDS), which enhances the bioavailability of celecoxib. This formulation has shown pronounced improvement in bioavailability compared with celecoxib capsules, allowing for a low dose of celecoxib in the oral solution to provide safe and effective acute migraine treatment. The American Headache Society recently updated their consensus statement for the acute treatment of migraine to include celecoxib oral solution formulated in SMEDDS.
Scilex's Broader Pain Management Portfolio
Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Their portfolio includes ZTlido (lidocaine topical system) for postherpetic neuralgia and Gloperba for gout flare prophylaxis. The potential approval of ELYXYB for acute pain would further solidify Scilex's position in the pain management market.
"We are well positioned to broaden the ELYXYB label with an additional acute pain indication and further solidify the potential role of ELYXYB as a cornerstone in opioid-sparing acute pain management regimens that support accelerated recovery and eventually freedom from pain," said Dmitri Lissin, M.D., Chief Medical Officer of Scilex.
