PALO ALTO, Calif., Nov. 21, 2023 (Globe Newswire) — Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative company focused on the acquisition, development and commercialization of non-opioid Revenue Generating Company Today Announces Increased Volume of ELYXYB, a Pain Management Product for the Treatment of Acute and Chronic Pain® Manufacture of (celecoxib oral solution) to meet the growing demand for ELYXYB® Inventory needs at distribution centers also increased. Scilex achieved another important corporate goal, producing his first commercial batch of Scilex, designated ELYXYB. This will enable us to meet the growing demand of future customers for rapid onset pain management regimens for the acute treatment of migraine.
ELYXYB is FDA-approved for the acute treatment of migraine with or without aura, is COX-2 selective, has proven safety, and is designed to provide rapid and long-term migraine relief. We believe this is the first and only ready-to-use oral solution designed to grown ups.1 Elixive® Studied in two randomized, double-blind trials involving 1,253 patients with paroxysmal migraine (with or without aura)2.Elixive® Treated patients experienced pain relief in just 15 minutes, and nearly 50% of patients saw significant pain relief compared to placebo within 45 minutes.2.Approximately 36% of patients became pain free in his 2 hours1. The US migraine drug market size is estimated to be $4.1 billion in 2022.3
“We are very excited about the potential of ELYXYB.® This is a highly complementary commercial asset that can provide physicians with another tool in their pain management arsenal to treat migraine in its earliest stages in patients as we continue to work towards redefining the role of opioids. is. Use it as a rescue drug of last resort,” said Jasim Shah, CEO and President of Silex.
For more information about ELYXYB, including complete prescribing information, please visit ELYXYB.com.
About Silex Holding Company
Scilex Holding Company is an innovative revenue generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex is uncompromisingly committed to being a global pain management leader committed to the social, environmental, economic and ethical principles of responsibly developing medicines to maximize quality of life. is. Results from the CLEAR program, a pivotal Phase 3 study of SEMDEXA™, a novel non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Silex attended the Type C meeting for pre-NDA purposes. After discussions with the FDA, we have reached an agreement to apply to the FDA for an NDA for SP-102 (SEMDEXA™) for the treatment of lumbosacral radicular pain (sciatica). Scilex is a non-opioid therapy for the treatment of patients with moderate to severe pain, targeting indications with high unmet need and significant market opportunity. Scilex launches first commercial product ZTlido® Introduced commercial product Gloperba in October 2018® The company launched its third FDA-approved product, Elyxyb™, in April 2023 in June 2022. The company is also developing a late-stage pipeline that includes one significant Phase 3 candidate, one Phase 2 candidate and one Phase 1 candidate. Its commercial product ZTlido® (lidocaine topical system) 1.8%, or ZTlido®is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia, a type of postherpetic neuralgia. Scilex has licensed exclusive rights to commercialize his Gloperba® (Colchicine USP) Oral Solution, FDA-Approved Preventive Treatment for Painful Gout Flares in Adults, Scilex Introduces Exclusive Rights to Commercialize Elyxyb in the United States® (celecoxib oral solution) is the only ready-to-use oral solution approved by the FDA for the acute treatment of migraine with or without aura in adults in the United States and Canada. Scilex launches his Elyxyb® Gloperba is scheduled to be commercialized in April 2023® By 2024, we will be well positioned to market and distribute these products. Scilex's three product candidates are SP-102, an injectable dexamethasone sodium phosphate viscous gel product containing 10 mg of dexamethasone, or Corti, a widely used epidural injection for the treatment of lumbosacral radicular pain. SEMDEXA™, a novel phase 3 viscous gel formulation of costosteroids. Sciatica, with FDA fast track status. SP-103 (lidocaine topical system) 5.4%, Phase 2 study, 3x stronger formulation of ZTlido®, has received FDA Fast Track status for the treatment of chronic neck pain. The Company expects that he will receive topline results for his SP-103 Phase 2 in August 2023 and that this study will demonstrate the safety, tolerability, and preliminary efficacy of his SP-103 in acute low back pain with muscle spasm. achieved the purpose of characterizing it. SP-103 was safe and well tolerated. Compared to the approved ZTlido, there was a 3-fold increase in lidocaine loading in the topical system (5.4% vs. 1.8%), but daily application over a 1-month treatment period resulted in no signs of systemic toxicity or application site did not cause an increase in response. The Company continues to analyze Phase 2 trial data for SP-103 in conjunction with the recently completed clinical trial study of ZTlido in patients with chronic neck pain, which also shows promising top-line efficacy and safety results. Results are shown. Scilex is expected to begin a Phase 2/3 trial in chronic neck pain in 2024. SP-104, a 4.5 mg delayed-burst-release low-dose naltrexone hydrochloride (DBR-LDN) capsule used to treat chronic pain, fibromyalgia, has completed multiple Phase 1 trial programs and is expected to enter Phase 2 in 2024. We are planning to start a phase trial.
Scilex Holding Company is headquartered in Palo Alto, California.
Forward-looking statements
This press release, and any statements made for or during presentations or conferences regarding the matters discussed in this press release, comply with the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Contains forward-looking statements relating to Scilex and its subsidiaries. They are also subject to risks and uncertainties that could cause actual results to differ materially from expectations. Forward-looking statements include statements regarding Scilex's estimates for ELYXYB's production and inventory increases;®Elixive®the potential to further expand Scilex's non-opioid portfolio; the potential market size for oral migraine and pain management treatments in the United States; plans to begin a Phase 2/3 trial for Scilex in chronic neck pain in 2024; and plans to begin Phase 2 trials of SP-104 in 2024; Scilex's belief that it is well-positioned to continue to grow in the coming years; Scilex's long-term goals and commercialization plans; Scilex's future opportunities, Scilex's future business strategy, Scilex's anticipated cash resources and their anticipated uses; Scilex's current and future product candidates, planned clinical trials and preclinical activities, potential product approvals, and the likelihood of market acceptance of approved products and related market opportunities; Statement about ZTlido®Gropelba®Elixive®, SP-102 (SEMDEXA™), SP-103, or SP-104 (if approved by the FDA). Scilex development and commercialization plans; Scilex products, technology and prospects.
Risks and uncertainties that could cause Scilex's actual results to differ materially and adversely from those expressed in the company's forward-looking statements include, but are not limited to: . the risk that Scilex may not achieve the expected results from the commercialization of his ELYXYB;®risks related to the unpredictability of trading markets and whether a market for Silex's common stock will become established; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that potential product candidates developed by Scilex may not proceed through clinical development or obtain necessary regulatory approvals within the expected schedule or at all; risks related to uncertainties regarding the regulatory pathway of Scilex's product candidates; the risk that Scilex will not be able to successfully bring its product candidates to market or will not be accepted by the market; the risk that Scilex's product candidates may not be beneficial to patients or be successfully commercialized; the risk that Scilex overestimates the size of the patient population it serves, the willingness to try new treatments and the willingness of physicians to prescribe these treatments; Risk that SP-102, SP-103, or SP-104 test results may not be successful. the risk that results from previous clinical trials of SP-102 (SEMDEXA™), SP-103, or SP-104 may not be replicated; Regulatory and Intellectual Property Risks. and other risks and uncertainties presented from time to time and described in Scilex's filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements. These statements speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statements in this press release, except as required by law.
contact address:
investors and media
Silex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
reference
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Source: Celecoxib oral solution, approved for acute migraine in March 2020.
https://www.neurologylive.com/view/celecoxib-oral-solution-gets-goahead-for-acute-migrane -
Lipton RB et al. J Painless 2021; 14:549-560
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Source: Evaluate Pharma data, February 16, 2023
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is scheduled.
ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly owned subsidiary of Scilex Holding Company.
Gropelba® is subject to an exclusive and transferable license to use registered trademarks by Scilex Holding Company.
Elixive® is subject to an exclusive and transferable license to use registered trademarks by Scilex Holding Company.
All other trademarks are the property of their respective owners.
© 2023 Silex Holding Company All Rights Reserved.
