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 and, following the
formation of its proposed joint venture with IPMC Company, in
neurodegenerative and cardiometabolic disease, today announced that
Pain Medicine News published retrospective claims data on ZTlido®
vs. lidocaine 5% patch.
Pain Medicine News, the premier trade publication in the pain
management space, published decreased opioid utilization
demonstrated with ZTlido® (lidocaine topical system 1.8%) in the
magazine’s December edition. The article concluded that
retrospective claims data showed that Scilex Pharmaceuticals’
flagship product, the branded ZTlido® lidocaine patch, was
associated with less use of opioid analgesics in patients with
neuropathic pain compared with the 5% lidocaine patch (generic).
The researchers looked at claims with a diagnosis of neuropathic
pain (postherpetic neuralgia, diabetic peripheral neuropathy or low
back pain) in the Optum Claims database from May 1, 2018, to Sept.
30, 2023.
Among the key conclusions were that:
- More patients treated with ZTlido®
saw either a decrease or discontinuation of opioid use compared
with those treated with the 5% patch (51.9% vs. 45.5%).
- Of all study patients reporting a
decrease in opioid use, significantly more in the ZTlido® group
experienced a 20% or greater reduction in opioid use, compared with
those treated with 5% lidocaine patch (21.3% vs. 13.4%;
P=0.0008).
- Patients on ZTlido® had a
non-significant change in their baseline opioid use (+3.1%;
P=0.146), while those using the 5% patch experienced a significant
increase in opioid use from baseline (+42.9%; P<0.001).
This study further affirms the difference between ZTlido®, as a
second-generation lidocaine topical system, versus older,
conventional lidocaine patches, and highlights the downstream
impact conferred by advanced technology and improved adhesion. The
full article may be accessed in the print edition of Pain Medicine
News or online in the digital edition at this link: December issue
of Pain Medicine News
For more information on Scilex Holding Company, refer to
www.scilexholding.com
For more information on Semnur Pharmaceuticals, Inc., refer to
www.semnurpharma.com
For more information on Scilex Holding Company Sustainability
Report, refer to www.scilexholding.com/investors/sustainability
For more information on ZTlido® including Full Prescribing
Information, refer to www.ztlido.com.
For more information on ELYXYB®, including Full Prescribing
Information, refer to www.elyxyb.com.
For more information on Gloperba®, including Full Prescribing
Information, refer to www.gloperba.com.
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info@scilexholding.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 and, following the formation of its proposed joint
venture with IPMC Company, in neurodegenerative and cardiometabolic
disease. Scilex targets indications with high unmet needs and large
market opportunities with non-opioid therapies for the treatment of
patients with acute and chronic pain and is dedicated to advancing
and improving patient outcomes. Scilex’s commercial products
include: (i) ZTlido® (lidocaine topical system) 1.8%, a
prescription lidocaine topical product approved by the U.S. Food
and Drug Administration (the “FDA”) for the relief of neuropathic
pain associated with postherpetic neuralgia, which is a form of
post-shingles nerve pain; (ii) ELYXYB®, a potential first-line
treatment and the only FDA-approved, ready-to-use oral solution for
the acute treatment of migraine, with or without aura, in adults;
and (iii) Gloperba®, the first and only liquid oral version of the
anti-gout medicine colchicine indicated for the prophylaxis of
painful gout flares in adults.
In addition, Scilex has three product candidates: (i) SP-102 (10
mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or
“SP-102”), a novel, viscous gel formulation of a widely used
corticosteroid for epidural injections to treat lumbosacral
radicular pain, or sciatica, for which Scilex has completed a Phase
3 study and was granted Fast Track status from the FDA in 2017;
(ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a
next-generation, triple-strength formulation of ZTlido, for the
treatment of acute pain and for which Scilex has recently completed
a Phase 2 trial in acute low back pain. SP-103 has been granted
Fast Track status from the FDA in low back pain; and (iii) SP-104
(4.5 mg, low-dose naltrexone hydrochloride delayed-release
capsules) (“SP-104”), a novel low-dose delayed-release naltrexone
hydrochloride being developed for the treatment of fibromyalgia,
for which Phase 1 trials were completed in the second quarter of
2022.
Scilex Holding Company is headquartered in Palo Alto,
California.
About Semnur Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical-late stage
specialty pharmaceutical company focused on the development and
commercialization of novel non-opioid pain therapies. Semnur’s
product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel
gel formulation administered epidurally in development for patients
with moderate to severe chronic radicular pain/sciatica.
Semnur Pharmaceuticals, Inc. 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 Pain Medicine News
published retrospective claims data on ZTlido® vs. lidocaine 5%
patch.
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 Board’s right to change the Record Date and/or
revoke the Dividend; Scilex’s ability to consummate a joint venture
or any other transaction with IPMC Company and develop and
commercialize treatments for obesity, neurodegenerative,
cardiometabolic disease; 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 and studies for SP-102, SP-103 or SP-104
may not be successful or reflect positive outcomes; 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 described
in Scilex’s most recent periodic reports filed with the Securities
and Exchange Commission, including Scilex’s Annual Report on Form
10-K for the year ended December 31, 2023 and subsequent Quarterly
Reports on Form 10-Q that the Company has filed or may file with
the SEC, including the risk factors set forth in those filings.
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 Scilex Holding Company to use the
registered trademark.
ELYXYB® is a registered trademark owned 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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