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 a
peer-review publication which contains results of skin penetration
studies conducted at the Institute for Biomedical Research and
Technologies, Graz, Austria. A set of studies assessed drug
delivery from SP-103, ZTlido and control (Pennsaid®, 2% diclofenac)
using open flow microperfusion. Interstitial fluid from the dermis,
subcutaneous adipose tissue, and muscle was continuously sampled to
assess drug penetration in all tissue layers. Ex vivo and in vivo
experiments showed a higher diffusive transport of lidocaine
compared to diclofenac. The data showed a clear contribution of
diffusive transport to lidocaine concentration, with SP-103
resulting in a significantly higher lidocaine concentration in
muscle tissue than commercially available ZTlido (p = 0.008). The
Company believes that these results indicate that SP-103 is highly
effective in delivering lidocaine into muscle tissue in areas of
localized pain for the treatment of musculoskeletal pain disorders.
Results of these studies were presented at the annual meeting of
American Association of Pharmaceutical Scientists (AAPS 2023
PHARMSCI 360), in Orlando, Florida on October 23, 2023; and
published in the peer-reviewed journal Pharmaceutics by
Multidisciplinary Digital Publishing Institute (MDPI).
A PDF accompanying this announcement is available
at: http://ml.globenewswire.com/Resource/Download/026e55c0-a98d-48b8-83b9-688d2a397f82
“We have developed SP-103 to deliver a triple strength
formulation of lidocaine per given area of skin covered by the
Topical Delivery System. Current results of skin penetration
studies for the first time had demonstrated uptake of lidocaine by
muscle tissue via a passive diffusion through the skin. This data
supports our supposition that a higher dose strength product may be
very useful in expanding the indication beyond peripheral
neuropathic pain (Post-Herpetic Neuralgia), to other types of pain,
including nociceptive musculoskeletal pain, like non-radicular neck
and low back pain. We are very excited about these results
supporting our clinical development plans,” said Dmitri Lissin, MD,
Chief Medical Officer at Scilex.
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 SEMDEXATM, 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 (SEMDEXATM) 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 ElyxybTM 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 ElyxybTM (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 ElyxybTM 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 for SP-103 to
be a highly effective treatment for musculoskeletal pain disorders,
Scilex’s belief that SP-103 may be useful in expanding the
indication beyond peripheral neuropathic pain to other types of
pain, 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
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 the
ongoing COVID-19 pandemic; 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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