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
publication in Anesthesiology Journal of results from an
investigator-initiated research study using ZTlido® for the
treatment of chronic neck pain.
The lifetime prevalence of neck pain in the adult population is
estimated to range from 14.2% to 71% with a mean of 48.5%.2 The
global market for topical medications is projected to increase from
$4.8 billion per year in 2021 to $7.3 billion per year in 2031.3
There are currently no approved medical treatments for neck pain in
the U.S. The study was a randomized, double-blind,
placebo-controlled crossover trial performed at four U.S. military,
Veterans Administration, academic, and private practice sites, in
which 76 patients were randomized to receive either a placebo patch
followed by ZTlido® for 4-week intervals or vice versa. The primary
outcome measure was mean reduction in average neck pain coupled
with the Patient Global Impression of Change.
The study demonstrated a clinical benefit trend for ZTlido® in
treatment of neck pain, where 27.7% of patients experienced a
positive outcome on ZTlido®, versus 14.9% on placebo. The effect
was more pronounced during the first study period, reaching
statistical significance. Analysis of both treatment periods did
not show significant results due to the carry-over effect of the
crossover study design and less than anticipated sample size due to
early termination of the study (COVID pause and drug expiration). A
positive trend was also observed for corresponding neck disability
index.
Overall, separation between ZTlido® and placebo effects and
variability observed in this patient population provided necessary
estimates for planning a potential Phase 3 development trial of
SP-103 (triple-strength formulation of ZTlido®), which contains
3-times higher concentration of lidocaine. Additionally, this study
provided essential insight into selection of patient population
responsive to topical lidocaine treatment. Application of ZTlido®
was well-tolerated and safety profile consistent with other ZTlido®
trials previously conducted by Scilex.
“Given the strong signal for clinically meaningful efficacy, our
study results point to a potential necessity of further
investigation of topical lidocaine treatment, especially in a
formulation that contain higher dose and greater skin penetration
than currently available alternatives, as it may provide greater
clinical benefit to patients with chronic neck pain,” said
Principal Investigator, Dr. Steven P. Cohen, Chief of Pain Medicine
and Professor of Anesthesiology & Critical Care Medicine,
Neurology, Physical Medicine & Rehabilitation, and Psychiatry
& Behavioral Sciences at the Johns Hopkins School of Medicine,
and Professor of Anesthesiology and Physical Medicine &
Rehabilitation at Walter Reed National Military Medical Center,
Uniformed Services University of the Health Sciences.
“This proof-of-principle study data using ZTlido® in addition to
our recently published skin penetration data demonstrating passive
diffusion of lidocaine from SP-103 into a muscle layer, provide
support for our strategy to pursue chronic neck pain indication for
our next generation topical lidocaine system, aiming to become the
first therapy approved for such common medical condition with
significant unmet need for safe and effective non-addictive
treatment,” said Dmitri Lissin, M.D., Chief Medical Officer of
Scilex.
Neck pain, or cervicalgia, is one of the most common pain
presentations in U.S. and the 4th leading cause of disability. In
the U.S., 52.9M adults suffer from Neck Pain.4 Prevalence of Neck
Pain is estimated at greater than 20% of the adult population in
the U.S. 4 In 2022, it was reported that neck pain was
responsible for job absences among 25.5 million Americans, who
missed an average of 11.4 days of work per year4. According to a
2020 JAMA publication (Journal of the American Medical
Association), the U.S. low back and neck pain market is estimated
at $134.5B.4
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 in low back pain. 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 estimates for the
prevalence of neck pain and the market size for low-back and neck
pain market in the U.S., the results of the investigator-initiated
research study and the potential for such results to support a
potential Phase 3 development trial of SP-103, the potential market
size and the size of the patient population for acute pain in the
U.S., 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
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 and investigator-initiated 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
Reference
- Multicenter, Randomized,
Placebo-controlled Crossover Trial Evaluating Topical Lidocaine for
Mechanical Cervical Pain - Steven P. Cohen, M.D.; Thomas M. Larkin,
M.D.; Aidan S. Weitzner, B.S.; Edward Dolomisiewicz, M.D.; Eric J.
Wang, M.D.; Annie Hsu, M.D.; Mirinda Anderson-White, R.N.; Marin S.
Smith, P.T., D.P.T.; Zirong Zhao, M.D., Ph.D. Anesthesiology March
2024, Vol. 140, 513–523.
- Fejer R, Kyvik KO, Hartvigsen J:
The prevalence of neck pain in the world population: A systematic
critical review of the literature. Eur Spine J 2006;
15:834–48)
-
https://pubs.asahq.org/anesthesiology/article/140/3/513/139530/Multicenter-Randomized-Placebo-controlled
- Multicenter, Randomized, Placebo Controlled Cross Over Trial
Evaluating Topical Lidocaine for Mechanical Cervical Pain (Steven
P. Cohen)
- Sources: Somaye Kazeminasab et al.
Neck pain: global epidemiology, trends and risk factors; BMC
Musculoskelet Disord (2022);
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8725362/
Genebra et al. Prevalence and factors associated with neck pain:
a population-based study
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.
© 2024 Scilex Holding Company All Rights
Reserved.
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