Scilex Holding Company (SCILEX), a subsidiary of Sorrento
Therapeutics, Inc. (NASDAQ: SRNE), announced that, effective
September 1, 2021, ZTlido® (lidocaine topical system) 1.8% has been
added to multiple formularies, including two national PBMs
(Pharmacy Benefit Managers), a national health plan and two
regional health plans – thereby expanding coverage by up to 33
million lives. ZTlido (zee-tee-lie-doh) is indicated for relief of
pain associated with post-herpetic neuralgia (PHN), also referred
to as post-shingles pain.
“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 Scilex Holding Company. “ZTlido provides fast and
significant PHN pain relief that can be sustained over time –
without the trade-offs associated with other widely used options,
notably impaired cognition and weight gain (seen with
gabapentinoids), and analgesic tolerance and risk of addiction
(seen with opioids). 1-4 In fact, ZTlido can be used in combination
to optimize gabapentinoids by delivering additive, remarkable pain
relief without adding to systemic adverse events – and the
combination has the potential to reduce the use of
opioids.”1,5,6,*
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 U.S. Food and Drug Administration
(FDA) in 2018 for relief of pain associated with post-herpetic
neuralgia (PHN) in adults. Side effects of ZTlido include
application site reactions such as, irritation, erythema, and
pruritus.
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 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.
*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.
About Sorrento Therapeutics, Inc. 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 February 28, 2018.
For more information visit www.sorrentotherapeutics.com.
About Scilex Holding
Scilex Holding Company, a subsidiary of Sorrento, 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 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
one Phase 2 and one Phase 1/2 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
post-herpetic neuralgia, which is a form of post-shingles nerve
pain. Scilex’s three product candidates are SP-102 (injectable
dexamethasone sodium phosphate viscous gel product containing 10 mg
dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel
formulation of a widely used corticosteroid for epidural injections
to treat lumbosacral radicular pain, or sciatica, with FDA Fast
Track status; SP-103 (lidocaine topical system) 5.4%, or SP-103, a
Phase 2, next-generation, triple-strength formulation of ZTlido®,
for the treatment of low back pain, and SP-104, 4.5 mg Delayed
Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule,
for the treatment of chronic pain, fibromyalgia, and chronic
post-COVID syndrome (“long haul COVID” or “long COVID”) in multiple
Phase 1 programs planned to be initiated this year. For further
information regarding the SP-102 Phase 3 efficacy trial, see NCT
identifier NCT03372161 – Corticosteroid Lumbar Epidural
Analgesia for Radiculopathy – Full Text View –
ClinicalTrials.gov
Scilex Holding Company is headquartered in Palo Alto,
California, with operations in both Palo Alto and San Diego,
California. For further information please
visit www.scilexpharma.com.
Forward-Looking Statement
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 to Scilex Holding Company, 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 advantages of ZTlido over other products, including with
respect to trade-offs associated with other available options and
its bioavailability and adhesive qualities; the use of ZTlido in
combination with gabapentinoids and any potential reduction in the
use of opioids; ZTlido’s ability to deliver pain relief for the
full treatment duration; and Scilex’s and Sorrento’s prospects and
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, 2020, and
subsequent Quarterly Reports on Form 10-Q filed with the Securities
and Exchange Commission, 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.
Media and Investor Relations Contact:
Alexis Nahama, DVM (SVP Corporate
Development)Email: mediarelations@sorrentotherapeutics.comTelephone:
1.858.203.4120
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.G-MAB™, DAR-T™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™,
COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics,
Inc.SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.SCILEX®
and ZTlido® are registered trademarks of Scilex Pharmaceuticals
Inc.All other trademarks are the property of their respective
owners.
©2021 Sorrento Therapeutics, Inc. All Rights Reserved.
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