Scilex Holding Company Announces Market Research Results with Neurologists, Headache Specialists, and Primary Care Physicians Demonstrating Potential High Unmet Needs In Treating Acute Migraine Targeted By ELYXYB® with Potential Advantages Compared to Calcitonin Gene-Related Peptide (CGRP) Products and Triptan Therapy
November 23, 2023Exhibit A
Exhibit A
Exhibit B
Exhibit B
Exhibit C
Exhibit C
Migraines affect over 37 million Americans, according to the Migraine Research Foundation (MRF).1Migraine-related pain is the third most prevalent illness in the world.1According to the Global Burden of Disease study, migraines are the second leading cause of disability worldwide.1A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2Elyxyb® (celecoxib oral solution) profile is preferred by physicians to address migraine attacks that often involve throbbing, nausea, sensitivity to light and sound, and other symptoms that can last extended periods of time often ranging from 4 to 72 hours.1 PALO ALTO, Calif., Nov. 22, 2023 (GLOBE NEWSWIRE) — 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, today announced that the key product attributes of ELYXYB® meet the high unmet needs of clinicians treating patients with acute migraine, with and without aura, in adults, based on the results from a recent market research study. A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2 Clinicians stated their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use. ELYXYB’s product profile mapped with a high degree of certainty to these stated unmet needs. In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in nearly 50% of patients. Approximately 34% of patients were pain free at two hours.3 Notably, these data are well differentiated from two other new oral migraine medications of a different class, calcitonin gene-related peptide (CGRP) receptor antagonists. Recent data from a post hoc analysis presented at the Brain Week Conference in Las Vegas showcased that ELYXYB® had higher pain freedom rates from 60 minutes through 3 hours post-dose compared to ubrogepant 100 mg and rimegepant 75 mg.4 As a low-dose COX-2 inhibitor, ELYXYB was safe and well-tolerated in large Phase III clinical studies of 1,253 patients.3 The most common adverse reaction was dysgeusia (3% of patients on ELYXYB vs 1% on placebo).3 Unlike triptans, ELYXYB is not contraindicated in patients with cardiovascular conditions.5 For more information on ELYXYB, including Full Prescribing Information, refer to the Exhibits hereto and visit ELYXYB.com. Exhibit A Exhibit B Exhibit C About Scilex 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 uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement on a path forward to file an NDA for SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain (Sciatica) with the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product ZTlido® in October 2018, in-licensed a commercial product Gloperba® in June 2022, and launched its third FDA-approved product Elyxyb™ in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 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 post-herpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex in-licensed the exclusive rights to commercialize Elyxyb® (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Scilex launched Elyxyb® in April 2023, and is planning to commercialize Gloperba® by 2024, and is well-positioned to market and distribute those products. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, a Phase 2 study, triple-strength formulation of ZTlido®, for the treatment of chronic neck pain, with FDA Fast Track status. We received our SP-103 Phase 2 top-line results in August 2023 and the trial achieved its objectives characterizing safety, tolerability and preliminary efficacy of SP-103 in acute low back pain associated with muscle spasms. SP-103 was safe and well-tolerated. Increase of lidocaine load in topical system by three times, compared with approved ZTlido, 5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month treatment. We will continue to analyze the SP-103 Phase 2 trial data along with a recently completed investigator study of ZTlido in patients with chronic neck pain which also has showed promising top-line efficacy and safety results. Scilex is planning to initiate Phase 2/3 trial in chronic neck pain in 2024; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia that has completed multiple Phase 1 trial programs and is expected to initiate Phase 2 trials in 2024. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding ELYXYB®’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating acute migraine, the findings of the recent market research study, the potential market size for U.S. oral migraine drugs and for pain management therapeutics, Scilex’s plans to initiate a Phase 2/3 trial in chronic neck pain in 2024 and plans to initiate Phase 2 trials in 2024 for SP-104, Scilex’s belief that it is well positioned to continue its growth over the next several years, Scilex’s long-term objectives and commercialization plans, Scilex’s potential to attract new capital, future opportunities for Scilex, Scilex’s future business strategies, the expected cash resources of Scilex and the expected uses thereof; Scilex’s current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlido®, Gloperba®, ELYXYB®, SP-102 (SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s development and commercialization plans; and Scilex’s products, technologies and prospects. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks that Scilex may not achieve the results expected from the commercialization of ELYXYB®; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials for SP-102, SP-103 or SP-104 may not be successful; risks that the prior results of the 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 indicated from time to time and other risks set forth in Scilex’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: [email protected] Website: www.scilexholding.com References Anita Gupta: https://blogs.webmd.com/pain-management/20231120/managing-migrainesData on file. Scilex Holding CompanyLipton RB, et al. J Pain Res 2021; 14:549-560.Tepper, SJ, Serrano D, Chan EK. Pain Freedom With Celecoxib Oral Solution, Ubrogepant, and Rimegepant Through 4 Hours Postdose: Post Hoc Analysis in the Acute Treatment of Migraine. Poster presented BRAINWeek September 6, 2023; Las Vegas, NV.ELYXYB package insert. 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 planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2023 Scilex Holding Company All Rights Reserved. Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/7738cbba-5a4e-4390-a3a5-89a48791e0dc https://www.globenewswire.com/NewsRoom/AttachmentNg/dbea46c6-4b53-48ee-adba-9dba94586a9f https://www.globenewswire.com/NewsRoom/AttachmentNg/5003c08d-5712-405c-b213-a3486884f01d