Scilex Holding (“Scilex”), an over 99% owned subsidiary of Sorrento
Therapeutics (NASDAQ: SRNE, “Sorrento”), has received a
supplemental new drug application (sNDA) approval from the FDA for
ZTlido® to make efficacy labeling change with clinical data.
ZTlido® is the only lidocaine topical system that has been
studied under the water stress conditions, and now has FDA label
reflecting its use while showering, swimming and bathing. It gives
polymer-based ZTlido® a competitive edge as other systems,
especially water-based or hydrogel-based formulations, cannot be
used when wet and must be removed prior to water exposure.
In the previous clinical trial (NCT04784728), a randomized,
crossover, adhesion performance and pharmacokinetic study under
conditions of water exposure in healthy subjects, Scilex had
demonstrated that upon immersing the lidocaine topical system 1.8%
(ZTlido®) in water, wet topical systems can be successfully
reapplied, if necessary, and remain adhered for up to the labeled
administration period of 12 hours. The trial showed that the
topical system may be used while showering and that this does not
increase lidocaine plasma levels. The topical systems were
well-tolerated under all conditions and the dermal irritation
profile was benign.
"We are very pleased with the trial outcome and labeling
revision that attests to characteristics of ZTlido superior to
other topical systems, to give patients a more reliable and
uninterrupted drug delivery to alleviate pain associated with
post-herpetic neuralgia," said Dmitri Lissin, MD, Chief Medical
Officer of Scilex.
About Sorrento Therapeutics
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®", “Seprehvec™”). Sorrento is
also developing potential antiviral therapies and vaccines against
coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic
test solutions, including COVI-TRACK™, COVI-STIX™ and
COVI-TRACE™.
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 ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX has
completed a phase 1B trial for intractable pain associated with
cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was
approved by the FDA on February 28, 2018. SP-102 is undergoing a
Phase 3 pivotal trial for the treatment of lumbosacral radicular
pain/sciatica.
For more information visit www.sorrentotherapeutics.com
About Scilex Holding
Scilex Holding Company, a majority-owned 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 chronic 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 two Phase 2 candidates. 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
postherpetic neuralgia, which is a form of post-shingles nerve
pain. Scilex’s three product candidates are SP-102 (10 mg,
dexamethasone sodium phosphate viscous gel), 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, Delayed Burst Release Low Dose Naltrexone
(DBR-LDN), for the treatment of chronic pain, fibromyalgia, and
chronic post-COVID syndrome (“long haul COVID” or “long COVID”) in
multiple Phase 2 programs planned to be initiated this year.
For more information visit www.scilexpharma.com
Forward-Looking Statements
This press release and any statements made for and during any
presentation or meeting concerning the matters discussed in this
press release contain forward-looking statements related to
Sorrento Therapeutics, Inc. and its subsidiaries, including but not
limited to Scilex, 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 ZTlido®’s prospects,
Sorrento’s products, technologies and prospects and Scilex’s
products, technologies and prospects. 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 the risk that the results of a previous
clinical trial (NCT04784728) for ZTlido® may not be replicated,
regulatory and intellectual property risks and other risks set
forth in Sorrento’s filings with the Securities and Exchange
Commission. 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 may be
required by law.
Media and Investor Relations
Contact: Alexis Nahama, DVM
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Website: www.sorrentotherapeutics.com
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, respectively.
SEMDEXA™ (SP-102) is a trademark owned by Scilex Holding. A
proprietary name review by the FDA is planned.
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.
© 2021 Sorrento Therapeutics, Inc. All Rights Reserved.
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