World News: 12:00 GMT Monday 14th January 2019. [Sorrento Therapeutics, Inc. via Globe Newswire via SPi World News]
SAN DIEGO, Jan. 14, 2019 (GLOBE NEWSWIRE) -- Scilex Pharmaceuticals Inc. (SCILEX), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE), today announced that ZTlido (lidocaine topical system) 1.8% (ZTLIDO) is covered by nearly 100M U.S. insured lives. ZTLIDO is indicated for relief of pain associated with postherpetic neuralgia (PHN), also referred to as post-shingles pain.
“SCILEX has been working closely with pharmacy benefit managers (PBMs) and health plans to help ensure patients and providers have access to ZTLIDO, a non-opioid, non-abusive treatment option for post-herpetic neuralgia,” said Mike Sweeting, Vice President, Market Access, Scilex. “Having launched ZTLIDO less than 90 days ago, we think achieving 47% commercial coverage this quickly is a testament that health plans and pharmacy benefit managers (PBMs) believe ZTLIDO can be part of the solution as we fight the opioid epidemic.”
ZTLIDO is a topical system product that uses an advanced adhesion technology, providing more efficient lidocaine delivery than Lidoderm® (lidocaine patch 5%)* over a full 12 hours. Poor adhesion is the most common complaint of lidocaine patches, and based on clinical data, ZTLIDO has proven adhesion superiority over Lidoderm. PHN is the most common complication of shingles, a condition caused by the herpes zoster virus. PHN affects an estimated 1 million people in the United States each year.
ZTLIDO was approved by the U.S. Food and Drug Administration (FDA) in February 2018 for relief of pain associated with PHN.
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.
To report SUSPECTED ADVERSE REACTIONS, contact SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3 or contact FDA at 1-800-FDA-1088 or .
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Sorrento’s commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido. Resiniferatoxin is completing a phase IB trial in terminal cancer patients.
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Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
G-MAB™ is a trademark owned by Sorrento Therapeutics, Inc.
SCILEX and ZTLIDO are registered trademarks of Scilex Pharmaceuticals Inc.
Seprehvir is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.
*Lidoderm is a registered trademark of Hind Health Care, Inc.
Globe Newswire: 12:00 GMT Monday 14th January 2019
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