Scilex Announces the Availability of ZTlido™
SAN DIEGO, Oct. 01, 2018 (GLOBE NEWSWIRE) -- Scilex Pharmaceuticals Inc. (Scilex), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (Sorrento), announced that ZTlido™ (lidocaine topical system) 1.8% (ZTLIDO) is now commercially available. ZTLIDO will be shipped to wholesalers and is anticipated to be available by prescription at retail pharmacies across the U.S. by the end of this week, thus commencing a full U.S. launch.
“Today marks a significant organizational milestone as Scilex transitions to a commercial entity with the launch of ZTLIDO,” said George Ng, President, Business, of Scilex. “We are pleased to introduce a non-opioid, first line alternative and option for patients with post-herpetic neuralgia, and with the recent $140 million, non-dilutive raise and commercial infrastructure we have built, we believe we have the resources and tools to support the launch and commercialization of ZTLIDO.”
Scilex has entered into an agreement with Syneos Health (formerly, Inventiv Health) to support the launch and commercialization of ZTLIDO in the U.S. ZTLIDO is supported by an experienced, field sales team of over a hundred sales representatives, as well as Medical Science Liaison (MSL), market access and trade teams.
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.
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.
Adverse ReactionsSide 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 PopulationsUse 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 SCILEX Pharmaceuticals Inc. at1-866-SCILEX3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For full Prescribing Information, please visit www.ztlido.com.
About Scilex Pharmaceuticals Inc.
Scilex, a majority-owned subsidiary of Sorrento located in San Diego, California, leverages on its core, proprietary technologies to responsibly develop next generation, branded pharmaceutical products to better manage critical conditions and maximize the quality of life of patients and healthcare providers. We are uncompromising in our focus to become the global pharmaceutical leader committed to social, environmental, economic, and ethical responsibility. Leveraging on our global partnerships, we deliver the next generation of products that are responsible by design. The Company’s product, ZTlido™ (lidocaine topical system) 1.8%, is a branded lidocaine topical system formulation for the treatment of relieving the pain of post-herpetic neuralgia, also referred to as after-shingles pain. For more information visit www.scilexpharma.com.
About Sorrento Therapeutics, Inc.
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.
Forward-Looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries, including but not limited Scilex Pharmaceuticals, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the timing of the commercial launch of ZTlido, the advantages of ZTlido over other products, the efficacy of ZTlido and its potential position as a first line therapy, the success of the launch of ZTlido, Scilex’ prospects, Sorrento’s strategy and other forward-looking statements. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: that ZTlido may not be commercially successful and other risks that are described in Sorrento’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2017, as amended, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, and if applicable, as amended, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ZTlido™ and G-MAB™ are trademarks owned by Scilex Pharmaceuticals, Inc., and Sorrento Therapeutics, Inc., respectively.
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.
All other trademarks are the property of their respective owners.
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