PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a pharmaceutical company with a current market capitalization of $82.28 million and impressive revenue growth of 22% over the last twelve months, announced today its submission of a Supplemental New Drug Application (SNDA) to the U.S. Food and Drug Administration (FDA) for ELYXYB®, a liquid oral solution of celecoxib, for the treatment of acute pain in adults. This move could potentially offer a non-opioid alternative in acute pain management.
ELYXYB®, already FDA-approved for acute migraine treatment, has been evaluated for its analgesic efficacy and safety in a double-blind, placebo-controlled study involving 120 adults following dental surgery. The study reported significant pain relief over six hours with ELYXYB® compared to placebo. Moreover, the treatment was generally well-received, with a similar incidence of adverse events to placebo and no evident dose-related effects.
The company aims to expand ELYXYB®'s label to include acute pain, which could position it as a key therapy in opioid-sparing pain management regimens. The American Headache Society's recent consensus statement for acute migraine treatment included celecoxib oral solution, formulated using self-microemulsifying drug delivery system (SMEDDS) technology, which has shown improved bioavailability over capsule forms.
Dr. Aakash A. Shah, physician for the NBA team Miami Heat, welcomed the advancement of ELYXYB® as it represents a shift towards opioid-sparing medications, important for both non-operative and post-operative pain control.
Scilex's dedication to non-opioid pain management is part of a broader strategy to address unmet needs in the treatment of acute and chronic pain. The company's portfolio also includes ZTlido® for postherpetic neuralgia and Gloperba® for gout flare prophylaxis.
The acute pain market in the U.S. was estimated to be approximately $3 billion in 2021, with around 40 million Americans prescribed opioids annually for acute pain. The introduction of ELYXYB® as an acute pain therapy could potentially impact this market and offer an alternative to habit-forming opioids. According to InvestingPro data, Scilex maintains a strong gross profit margin of 70%, though analysts anticipate continued challenges in achieving profitability this year. For comprehensive analysis and additional insights, including 8 more exclusive ProTips, consider exploring InvestingPro's detailed coverage.
This announcement is based on a press release statement from Scilex Holding Company. The FDA's decision on the SNDA for ELYXYB® will determine the product's future role in acute pain management. With analyst price targets ranging from $6.25 to $14.00, significantly above the current trading price, InvestingPro subscribers can access detailed valuation metrics and financial health scores to better evaluate the company's potential in this evolving market landscape.
In other recent news, Scilex Holding Company has reported a series of significant developments. The company recently completed a $17 million direct stock and warrant offering, which included over 26 million shares of common stock and warrants. The funds raised are planned for general corporate purposes, including research and development, commercialization, and potential acquisitions or debt repayment.
In addition to this financial restructuring, Scilex has also announced a joint venture with IPMC, named Scilex Bio, to develop and commercialize KDS2010, a new treatment for obesity and neurodegenerative diseases currently in Phase 2 clinical trials.
Furthermore, Scilex has reached agreements leading to the sale of a significant portion of its stock to meet debt obligations. The company has also appointed BPM LLP as its new independent registered public accounting firm, ensuring high standards of financial reporting and compliance.
A recent study linked the company's ZTlido patch to reduced opioid use in pain management, with 51.9% of patients treated with ZTlido experiencing either a decrease or a halt in opioid use. Analysts from H.C. Wainwright maintain a Buy rating on Scilex, indicating a positive outlook for the company. These recent developments underscore Scilex's ongoing efforts to manage its financial health and operational performance.
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