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 that a
recent market research study among rheumatologists revealed a high
degree of interest in Gloperba® as a liquid colchicine formulation
designed for precision dosing.5 Specifically, clinicians using
colchicine for prophylaxis of gout flares in adults indicated a
strong likelihood to use Gloperba® instead of tablets/capsules in
certain at-risk patient populations who have a clinical need for
lowered precision dosing to mitigate the risk of colchicine
toxicity. Notably, the American College of Rheumatology (ACR)
guidelines also reflect this need.6 Scilex is currently in
discussions with the U.S. Food and Drug Administration (FDA)
regarding the dosing recommendations for these patient populations.
For more information on Gloperba®, visit
https://www.gloperba.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 Gloperba’s potential to
further expand Scilex’s non-opioid portfolio and its potential to
address high unmet needs in treating gout, the potential market
size and the size of the patient population for gout in the U.S.,
the findings of the recent market research study with
rheumatologists, 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 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
1) https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%25%20of%20the%20adult%20population2)
Evaluate Pharma data3) Comorbidities of Gout and Hyperuricemia in
the US General Population: NHANES 2007-20084) Stewart et al.
Arthritis Research & Therapy (2020) 22:28;
https://doi.org/10.1186/s13075-020-2120-75) Scilex market research
study of US rheumatologists, Nov-Dec 20236) Khanna D, et al. 2012
American College of Rheumatology Guidelines for Management of Gout.
Part 2: Therapy and Antiinflammatory Prophylaxis of Acute Gouty
Arthritis. Arthritis Care & Research. Vol. 64, No. 10, October
2012, pp 1447–1461
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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