Scilex Announces Pricing and Availability of ZTlido™ for the Commercial Launch of its First Product in October of 2018
“We are excited to bring our first commercial product to the market,” said
ZTLIDO is a topical product that uses an advanced adhesion technology providing more efficient lidocaine delivery than Lidoderm® over a full 12 hours. Post-herpetic neuralgia (PHN), also referred to as post-shingles pain, is a frequent complication of shingles, a condition caused by the herpes zoster (HZ) virus, which afflicts an estimated 1 million people each year in the US.
This Announcement Follows the Recent Release of Clinical Data at the Annual Painweek® Meeting in
Superior adhesion performance of ZTlido, Lidoderm and Versatis; Bioequivalence of ZTlido 1.8% to Lidoderm 5%; and Underutilization of Lidocaine Patches in the Treatment of PHN were poster presentations introducing ZTlido as a new treatment option for patients suffering from pain associated with PHN.
About ZTlido™ (lidocaine topical system 1.8%)
ZTLIDO is indicated for relief of pain associated with post-herpetic neuralgia (PHN).
Important Safety Information
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.
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 (eg, eye glasses/eye wear) until sensation returns.
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 women are not sufficient to inform drug-associated risk for major birth defects and miscarriage.
To report SUSPECTED ADVERSE REACTIONS, contact
For full Prescribing Information, please visit www.ztlido.com.
Scilex, a majority-owned subsidiary of Sorrento located in
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. 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”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Sephrevir®”).
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.
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
Sorrento® and the Sorrento logo are registered trademarks of
ZTlido™ and G-MAB™ are trademarks owned by
Seprehvir® is a registered trademark of
All other trademarks are the property of their respective owners.
Media and Investor Relations Contact:
William PedrantiTelephone: (949) 441-2270 Email: email@example.com
Source: Sorrento Therapeutics, Inc.