Scilex Holding Company Announces that According to Prescription Data from Symphony Health, ZTlido is the Most Prescribed Non-Opioid Branded Pain Treatment By Pain Specialists

• ZTlido is the most prescribed non-opioid, branded pain treatment prescribed by pain specialists.¹
• Total ZTlido NRx (New Drug Prescription) market share for the non-opioid branded pain treatment market grew to 14.2% in October 2023, compared to 11.8% in October 2022 according to prescription data from Symphony Health.¹
• As previously reported certain preliminary unaudited financial results for gross sales for year-to-date through November 30, 2023.
  • ZTlido year-to-date gross sales through November 2023 were in the range of $125.0 million to $135.0 million, compared to $84.6 million for year-to-date through November 2022, representing growth in the range of approximately 48% to 60%.
• Projected full year gross sales for ZTlido in 2023 are estimated to be in the range of $140.0 million to $150.0 million, compared to $96.0 million in 2022, representing estimated growth in the range of approximately 46% to 56%.
  

PALO ALTO, Calif., Dec. 20, 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 according to prescription data from Symphony Health, ZTlido is the most prescribed non-opioid, branded pain treatment prescribed by pain specialists. Total ZTlido NRx (New Drug Prescription) market share grew to 14.2% in October 2023, compared to 11.8% in October 2022 according to prescription data from Symphony Health.

For more information on ZTlido including Full Prescribing Information, refer to www.ztlido.com.

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.