PALO ALTO, Calif., Oct. 01, 2019 (GLOBE NEWSWIRE) -- Scilex Holding Company (Scilex), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE), is excited to announce that its subsidiary, Scilex Pharmaceuticals, Inc., (together, with Scilex Holding Company, “Scilex”) has entered into multiple Medicaid agreements to facilitate access to ZTlido® (lidocaine topical system) 1.8% for nearly 6 million Medicaid recipients in the states of California and Florida. These contracts are in addition to the 130 million U.S. insured lives that already enjoy access to ZTlido. ZTlido is indicated for relief of pain associated with postherpetic neuralgia (PHN), which is a form of post-shingles pain.
“Scilex has been working with payers across the country to ensure patients and providers will have access to ZTlido, a non-opioid, non-addictive treatment option for post-herpetic neuralgia,” said Jaisim Shah, CEO & President of Scilex. “Scilex is committed to being part of the solution to the nation’s opioid epidemic, and these agreements are important milestones for the organization.”
ZTlido is a topical system product that was strategically designed to address the limitations of current prescription lidocaine patches by providing improved adhesion and 12 hours of continuous pain relief. Poor adhesion is a leading problem for topical lidocaine patches,1 and ZTlido has demonstrated improved adhesion compared to Lidoderm.2 According to Datamonitor Healthcare, there were over 1.5 million people living with PHN conditions in the United States in 2017.
ZTlido was approved by the U.S. Food and Drug Administration (FDA) in February 2018 for relief of pain associated with PHN.
About ZTlido (lidocaine topical system) 1.8%
Indication
ZTlido is indicated for relief of pain associated with post-herpetic neuralgia (PHN).
Important Safety Information
Contraindications
ZTlido is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.
Warnings and Precautions
Accidental exposure can occur even after a ZTlido patch has been used. Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used ZTlido patch. Store and dispose of patches properly and keep out of reach of children and pets.
Excessive dosing or overexposure to lidocaine can occur. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine. If lidocaine overdose is suspected, check drug blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.
Cases of methemoglobinemia have been reported with local anesthetic use, although patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, or concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. Signs and symptoms include cyanotic skin discoloration and/or abnormal coloration of the blood and may occur immediately or may be delayed after exposure. Methemoglobin levels may continue to rise leading to more serious central nervous system and cardiovascular adverse effects. Discontinue ZTlido and any other oxidizing agents. Depending on severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Application site reactions can occur during or immediately after treatment with ZTlido. This may include development of blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Inform patients of these potential reactions and that severe skin irritation may occur with ZTlido if applied for a longer period than instructed.
Hypersensitivity cross-reactions may be possible for patients allergic to PABA derivatives. Manage hypersensitivity reactions by conventional means.
Eye exposure with ZTlido should be avoided. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye (such as, eye glasses/eye wear) until sensation returns.
Adverse Reactions
Side effects of ZTlido include application site reactions such as, irritation, erythema, and pruritus. These are not all of the adverse reactions that may occur. Please see Full Prescribing Information for more information.
Use in Specific Populations
Use of ZTlido during lactation should be used with caution as lidocaine is excreted into breast milk. The limited human data with lidocaine in pregnant woman is not sufficient to inform drug-associated risk for major birth defects and miscarriage.
To report SUSPECTED ADVERSE REACTIONS, contact SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information
About Scilex Holding Company
Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE), is a commercial-stage, non-opioid pain management company focused on the development and commercialization of topical and injectable therapies. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe chronic pain. Scilex launched its first commercial product in October 2018 and is developing its late-stage pipeline, which includes a pivotal Phase 3 candidate and a Phase 2 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, which is a form of post-shingles nerve pain. Scilex’s two product candidates are SP-102 (10 mg, dexamethasone sodium phosphate viscous gel), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and SP-103 (lidocaine topical system) 5.4%, or SP-103, a Phase 2, next-generation, triple-strength formulation of ZTlido, for the treatment of chronic low back pain.
Media and Investor Relations
Contact: Michael Faerm, Chief Business Officer and Interim Chief Financial Officer, Scilex Holding Company
Telephone: 650-516-4310
Email: mfaerm@scilexpharma.com
SCILEX® and ZTlido® are registered trademarks of Scilex Pharmaceuticals Inc.
All other trademarks are the property of their respective owners.
References
1. U.S. Food and Drug Administration. FDA Adverse Events Reporting System (FAERS) Public Dashboard. Data as of June 30, 2019.
2. Data on File. SCILEX Pharmaceuticals Inc.