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
ZTlido® has reached three major milestones since it launched in
October 2018.
The following three milestones are a testament to the perceived
confidence that patients and health care providers have in
ZTlido®:
- Over one million patients are
estimated to have been treated with ZTlido® since its launch
according to Symphony Health prescription data.
- ZTlido® is now the
number one prescribed non-opioid branded pain medication by pain
specialists in the United States, based on Symphony Health
prescription data gathered from January 2023 to November 2023.
- Patients report 89%
satisfaction with ZTlido®, in a 2023 patient survey conducted by
Scilex (n=100, rating as “completely” or “mostly” satisfied with
ZTlido® treatment).
ZTlido has been strategically designed to address poor adhesion,
a leading complaint associated with other currently marketed
topical lidocaine products. In clinical studies, the technology
behind ZTlido manufacturing provided significantly improved
adhesion over Lidoderm® (a branded, prescription 5% lidocaine patch
product) and other generic lidocaine patches at 12 hours after
application. In a head-to-head study of 44 subjects, ZTlido
demonstrated statistically significant adhesion at all-time points
compared to other lidocaine patches.1
“We are pleased to learn that an estimated over 1 million
patients in the U.S. have been treated with ZTlido® emphasizing one
of the key paradigm shifts in patient care of increasing use of
opioid sparing regimens. We strive to continue to support the
market’s ongoing migration away from opioid agents in 2024 and lead
the way in providing increasing non-opioid pain relief therapeutics
with our upcoming third opioid sparing product launch, Gloperba®”,
said Jaisim Shah, Chief Executive Officer and President of
Scilex.
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.
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 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 are 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, expected to launch in 2024.
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; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a
next-generation, triple-strength formulation of ZTlido, for the
treatment of chronic neck pain and for which Scilex has recently
completed a Phase 2 trial 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 and a Phase 2 clinical trial is expected to commence 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 patient figures treated with ZTlido®, reports that
ZTlido® is the number one prescribed non-opioid branded pain
medication and statements regarding patient satisfaction reports,
the market’s migration away from opioid agents and the potential to
provide increased non-opioid pain relieve with the launch of
Gloperba, Scilex’s plans to launch Gloperba in 2024 and plans to
initiate a Phase 2 trial in 2024 for SP-104.
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
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, 2022 and subsequent Quarterly Reports on Form 10-Q
filed with the Securities and Exchange Commission, 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
Reference
1) A Scilex-sponsored head-to-head
comparative adhesion study (SCI-LIDO-ADH-003)
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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