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
the out-of-pocket costs for its product portfolio for commercially
insured patients is expected to be capped at $25 monthly, with
certain eligible patients paying as low as $0. This applies to the
Company's postherpetic neuralgia pain product, ZTlido®, migraine
product, ELYXYB®, and gout flare prophylaxis product, Gloperba®,
which is expected to launch in the first half of 2024. Scilex has
made significant investments to improve patient affordability and
access to its products and continues to build on the Company's
commitment to provide non-opioid pain management products to
patients.
Scilex has been working with its co-pay savings card
adjudicators to resolve the recent breakdown of processing of
insurance claims by Change Healthcare, following a cyber-attack on
Change Healthcare. Scilex is aware of the impact this disruption
has had on its patients and customers and has worked diligently to
resolve the issue. Starting today, co-pay savings card processing
for ZTlido® is expected to be restored to normal operations.
Scilex believes that high deductibles and copays shouldn’t
prevent anyone from receiving the medications they need. Scilex
co-pay programs is designed to help patients reduce their co-pays
and out-of-pocket costs for their medication. Our program partners
with various assistance programs to help make a patient’s
medication affordable.
For more information on Scilex Holding Company, refer to
www.scilexholding.com
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.
https://www.facebook.com/scilex.pharm
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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. 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 the first half
of 2024.
In addition, Scilex has three product candidates: (i) SP-102 (10
mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” 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 has 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 chronic neck pain and for which Scilex has recently
completed a Phase 2 trial in low back pain. SP-103 has 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 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 expected out-of-pocket
costs for commercially insured patients, the expectation that
co-pay savings card processing for ZTlido will be restored,
Scilex’s expectation to launch Gloperba® in the first half of 2024
and plans to initiate a Phase 2 clinical 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, 2023, 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 use the registered trademark by Scilex
Holding Company.
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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