Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an
innovative revenue-generating company focused on acquiring,
developing and commercializing non-opioid pain management products
for the treatment of acute and chronic pain, today announced the
successful completion of a Good Manufacturing Practices (GMP)
inspection by the U.S. Food and Drug Administration (FDA) of the
enhanced manufacturing facility of Oishi Koseido Co., Ltd. (Oishi)
for ZTlido® located in Tosu, Saga, Japan. This successful audit
allows Scilex to continue commercializing ZTlido® product
manufactured at 250kg scale at Oishi’s facility. This facility is
also the manufacturing site for SP-103 (lidocaine topical system,
atriple strength formulation of ZTlido®) that recently completed
trials in acute back pain and neck pain.
“This successful FDA GMP inspection highlights the GMP and
quality assurance of our partner Oishi’s manufacturing facility in
Japan, which is essential as we scale the commercial production of
ZTlido®,” said Jaisim Shah, Chief Executive Officer and President
of Scilex. “The successful FDA inspection for this enhanced
manufacturing site marks an important milestone for Scilex that
will enable us to increase our capacity to meet the growing demand
for ZTlido®.”
As previously announced, in November 2023, the United States
Patent and Trademark Office (USPTO) issued U.S. Patents No.
11,793,766 and No. 11,786,455 related to ZTlido®. The patent No.
11,793,766 titled “Non-aqueous Patch for the Relief of Pain,”
covers a method of relieving pain through the application of a
lidocaine-containing patch. The patent No. 11,786,455
titled “Non-aqueous Patch,” covers a non-aqueous lidocaine patch
with certain specifications, as well as a method of relieving pain
through the application of a non-aqueous lidocaine-containing
patch.
These patents further strengthen the Company’s intellectual
property portfolio and coverage for its lead commercial product,
ZTlido® (lidocaine topical system) 1.8%. Scilex submitted this
patent for listing in the FDA’s “Approved Drug Products with
Therapeutic Equivalence Evaluations” (the Orange Book) in November
2023.
For more information on ZTlido including Full Prescribing
Information, refer to www.ztlido.com.
About Scilex Holding Company
Scilex Holding Company is an innovative revenue-generating
company focused on acquiring, developing and commercializing
non-opioid pain management products for the treatment of acute and
chronic pain. Scilex is uncompromising in its focus to become the
global pain management leader committed to social, environmental,
economic, and ethical principles to responsibly develop
pharmaceutical products to maximize quality of life. Results from
the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its
novel, non-opioid product for the treatment of lumbosacral
radicular pain (sciatica), were announced in March 2022. Scilex
participated in the type C meeting for purposes of pre-NDA
discussion with the FDA and reached agreement on a path forward to
file an NDA for SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain
(Sciatica) with the FDA. 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 ZTlido® in October
2018, in-licensed a commercial product Gloperba® in June 2022, and
launched its third FDA-approved product Elyxyb® in April 2023. It
is also developing its late-stage pipeline, which includes a
pivotal Phase 3 candidate, and one Phase 2 and one Phase 1
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 in-licensed the
exclusive right to commercialize Gloperba® (colchicine USP) oral
solution, an FDA-approved prophylactic treatment for painful gout
flares in adults, in the U.S. Scilex in-licensed the exclusive
rights to commercialize Elyxyb® (celecoxib oral solution) in the
U.S. and Canada, the only FDA-approved ready-to-use oral solution
for the acute treatment of migraine, with or without aura, in
adults. Scilex launched Elyxyb® in April 2023, and is planning to
commercialize Gloperba® by 2024, and is well-positioned to market
and distribute those products. 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%, a Phase 2 study, triple-strength
formulation of ZTlido®, for the treatment of chronic neck pain,
with FDA Fast Track status. We received our SP-103 Phase 2 top-line
results in August 2023 and the trial achieved its objectives
characterizing safety, tolerability and preliminary efficacy of
SP-103 in acute low back pain associated with muscle spasms. SP-103
was safe and well-tolerated. Increase of lidocaine load in topical
system by three times, compared with approved ZTlido, 5.4% vs.
1.8%, did not result in signs of systemic toxicity or increased
application site reactions with daily applications over one month
treatment. We will continue to analyze the SP-103 Phase 2 trial
data along with a recently completed investigator study of ZTlido
in patients with chronic neck pain which also has showed promising
top-line efficacy and safety results. Scilex is planning to
initiate Phase 2/3 trial in chronic neck pain in 2024; and SP-104,
4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride
(DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia
that has completed multiple Phase 1 trial programs and is expected
to initiate Phase 2 trials in 2024.
Scilex Holding Company is headquartered in Palo Alto,
California.
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 Scilex
and its subsidiaries 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 potential impact of the
successful FDA audit on Scilex’s commercialization plans for
ZTlido®, Scilex’s plans to initiate a Phase 2/3 trial in chronic
neck pain in 2024 and plans to initiate Phase 2 trials in 2024 for
SP-104, Scilex’s belief that it is well positioned to continue its
growth over the next several years, Scilex’s long-term objectives
and commercialization plans, Scilex’s potential to attract new
capital, future opportunities for Scilex, Scilex’s future business
strategies, the expected cash resources of Scilex and the expected
uses thereof; Scilex’s current and prospective product candidates,
planned clinical trials and preclinical activities and potential
product approvals, as well as the potential for market acceptance
of any approved products and the related market opportunity;
statements regarding ZTlido®, Gloperba®, ELYXYB®, SP-102
(SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s
development and commercialization plans; and Scilex’s products,
technologies and prospects.
Risks and uncertainties that could cause Scilex’s actual results
to differ materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risks
that Scilex may not achieve the results expected from the
commercialization of ZTlido®; risks associated with the
unpredictability of trading markets and whether a market will be
established for Scilex’s common stock; general economic, political
and business conditions; risks related to COVID-19 (and other
similar disruptions); the risk that the potential product
candidates that Scilex develops may not progress through clinical
development or receive required regulatory approvals within
expected timelines or at all; risks relating to uncertainty
regarding the regulatory pathway for Scilex’s product candidates;
the risk that Scilex will be unable to successfully market or gain
market acceptance of its product candidates; the risk that Scilex’s
product candidates may not be beneficial to patients or
successfully commercialized; the risk that Scilex has overestimated
the size of the target patient population, their willingness to try
new therapies and the willingness of physicians to prescribe these
therapies; risks that the outcome of the trials for SP-102, SP-103
or SP-104 may not be successful; risks that the prior results of
the clinical trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not
be replicated; regulatory and intellectual property risks; and
other risks and uncertainties indicated from time to time and other
risks set forth in Scilex’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 Scilex undertakes no obligation to
update any forward-looking statement in this press release except
as may be required by law.
Contacts:
Investors and MediaScilex Holding Company 960 San Antonio
RoadPalo Alto, CA 94303Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
SEMDEXA™ (SP-102) is a trademark owned by Semnur
Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding
Company. A proprietary name review by the FDA is planned.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex
Holding Company.
Gloperba® is the subject of an exclusive,
transferable license to use the registered trademark by Scilex
Holding Company.
ELYXYB® is the subject of an exclusive,
transferable license to use the registered trademark by Scilex
Holding Company.
All other trademarks are the property of their
respective owners.
© 2023 Scilex Holding Company All Rights
Reserved.
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