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, announced the State of
Indiana Medicaid will add Elyxyb as a preferred agent to its
Preferred Drug List (“PDL”) effective October 1, 2023.
As Indiana is a Single PDL State, where the five Indiana Managed
Medicaid plans (Anthem, CareSource, MDwise, Managed Health Services
(MHS), and UnitedHealthcare) must follow the State PDL, this change
improves access to Elyxyb for all eligible patients under the
Indiana Medicaid umbrella, the combined traditional Medicaid and
Managed Medicaid populations, totaling approximately 1.2M lives,
between the ages of 18-64.
Under the new terms, Elyxyb will be Preferred with the following
prior authorization (PA) criteria:
- Migraine Dx, 18 & Older
- Trial and failure of 1 preferred triptan or contraindication to
triptans
- Elyxyb will have a QL of 6 bottles.
“We are pleased to announce our first Elyxyb managed health care
win with the Medicaid plan in Indiana, which we believe is an
important step to expand utilization of Elyxyb throughout the U.S.
Importantly, our diversified portfolio of unique, leading programs
will increasingly allow us to offer patients complementary and
standalone opioid-sparing outpatient pain management solutions,”
said Jaisim Shah, Chief Executive Officer of Scilex Holding
Company.
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 SEMDEXATM, 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 is pending official minutes in writing
from 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 ElyxybTM 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 ElyxybTM (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 ElyxybTM 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 acute low back pain,
with FDA Fast Track status; 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 potential growth of
Elyxyb in managed care plans, the potential benefits related to the
addition of Elyxyb to the State of Indiana Medicaid PDL, 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 the
ongoing COVID-19 pandemic; 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-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
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 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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