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
expected plans to launch Gloperba, its novel liquid colchicine
formulation, in the first half of 2024 with a launch price of $595
per 150ml bottle. Gloperba is the only FDA approved liquid
formulation of colchicine for the prophylaxis of acute gout flares.
Over 70% of gout patients have chronic kidney disease and many
suffer from gastrointestinal sensitivity, necessitating a lower
dose of colchicine than the standard 0.6 mg tablet or capsule.
Gloperba is expected to be the first liquid colchicine formulation
that allows healthcare providers to prescribe precision dosing in
at-risk patient populations, and thereby help mitigate against
severe toxicity in patients. Healthcare providers can now safely
and effectively manage such patients at doses below 0.6 mg once or
twice daily, which is the standard dose for prophylaxis. In
patients who are treated at lower doses than 0.6 mg, the 150 ml
bottle of Gloperba is expected to last more than 30 days,
delivering additional value to patients.
A recent market research study among rheumatologists conducted
by Scilex 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
For more information on Gloperba®, including Full Prescribing
Information, refer to www.gloperba.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.
Facebook: https://www.facebook.com/scilex.pharm
LinkedIn: https://www.linkedin.com/company/scilex-holding-company
Email: 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) (“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 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 estimates for the gout
treatment market and affected patient population, estimates for
potential demand for Gloperba, estimates for the launch pricing of
Gloperba, the belief that Scilex is well-positioned to market and
distribute Gloperba, Scilex’s expectations for Gloperba to be the
first liquid colchicine formulation allowing providers to prescribe
precision dosing, Scilex’s expectations for Gloperba to last more
than 30 days in patients who are treated with lower doses than 0.6
mg, Scilex’s plans 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, 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) https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%25%20of%20the%20adult%20population1)
2) Evaluate Pharma data
3) Comorbidities of Gout and Hyperuricemia in the US General
Population: NHANES 2007-2008
4) Stewart et al. Arthritis Research & Therapy (2020) 22:28;
https://doi.org/10.1186/s13075-020-2120-7
5) Scilex market research study of US rheumatologists, Nov-Dec
2023
6) 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 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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