Scilex Holding Company, a Sorrento Therapeutics, Inc. Subsidiary Announces Expansion of Ztlido® Managed Care Coverage for Additional 33 Million Lives
“With this expansion, up to 65% of lives nationally have covered or better access to ZTlido, with a reduction in need for prior authorization,” said Jaisim Shah, President and Chief Executive Officer of
However, not all lidocaine patch products are created equal. ZTlido 1.8% uses proprietary ZTech advanced technology to provide 9x greater bioavailability versus 5% lidocaine patch and superior adhesion proven in head-to-head studies, and while showering, bathing or exercising.7-12 This ensures that pain relief is delivered for the full treatment duration, without interrupting a patient’s routine.
ZTlido was approved by the
About ZTlido® (lidocaine topical system) 1.8%
Indication: ZTLIDO is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults.
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. If application site reactions occur while the topical system is being worn, advise the patient to remove ZTLIDO and not to reapply until skin reactions subside.
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, eyeglasses/eyewear) 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
*Less is More: ZTlido 1.8% uses proprietary ZTech advanced technology for proven bioequivalence to 5% lidocaine patch, but with 9x greater bioavailability.7-9 Data are from studies performed with 5% lidocaine patch.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVI-STIX™ and COVITRACE™.
Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on
For more information visit www.sorrentotherapeutics.com.
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to
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Sorrento® and the Sorrento logo are registered trademarks of
G-MAB™, DAR-T™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of
SEMDEXA™ is a trademark of
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- Data on file.
SCILEX Pharmaceuticals Inc.SCI-LIDO-PK-001.
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Mallick-Searle T, Adler JA, Greuber E, Patel K, Vought K. ZTlido® (lidocaine topical system) 1.8% has superior adhesion compared to generic Mylan lidocaine patch 5%. Poster presented at: PAINWeek; September 3-7, 2019; Las Vegas, NV. SCILEX Pharmaceuticals Inc.Data on file: SCI-LIDO-ADH-003. SCILEX Pharmaceuticals Inc.Data on file: SCI-LIDO-ADH-002.
Source: Sorrento Therapeutics, Inc.