- Provides the clinical benefits of baclofen in rapidly
dissolvable granule formulation with flexible dosing for individual
patient needs
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced the commercial launch of LYVISPAH®, a
baclofen oral granules (5, 10 and 20 mg) specialty product approved
by the U.S. Food and Drug Administration (“FDA”) for the treatment
of spasticity related to multiple sclerosis and other spinal cord
disorders.
LYVISPAH is bioequivalent to oral baclofen tablets and provides
flexible, customized dosing with 5mg, 10mg and 20mg single-dose
packets of granules. The rapidly dissolving flavored granules
provide an alternative for patients with spasticity who also have
difficulty swallowing pills. The product can be administered three
ways: poured directly into the patient’s mouth with or without
water, mixed with liquids or foods, or through an enteral feeding
tube.
“This is the first Specialty product launch for the business
since Rytary® (carbidopa and levodopa) in 2015, and the first in a
cadence of new branded launches planned over the next several
years. The launch of LYVISPAH is the next step in our strategy to
expand our Specialty business and drive accelerated growth. As we
build our position in the neurology space, we see a clear need for
more options to treat spasticity resulting from multiple sclerosis
and other spinal cord disorders based on individual patient’s
needs. We believe LYVISPAH provides that option,” said Chirag and
Chintu Patel, Co-Chief Executive Officers.
In January, Amneal announced the acquisition of Saol
Therapeutics’ baclofen franchise and the expansion of its neurology
presence into spasticity with LYVISPAH and Lioresal® (baclofen), a
baclofen product delivered through an implantable intrathecal pump
for use in the management of severe spasticity of cerebral or
spinal origin for the institutional market.
Baclofen, a skeletal muscle relaxant, is well established for
the treatment of spasticity and spinal cord injuries. It was first
approved by the FDA in 1977. The FDA-approved labeling says that
LYVISPAH oral granules are indicated for the treatment of
spasticity resulting from multiple sclerosis, particularly for the
relief of flexor spasms and concomitant pain, clonus, and muscular
rigidity, and may also be of some value in patients with spinal
cord injuries and other spinal cord diseases. LYVISPAH is not
indicated in the treatment of skeletal muscle spasm resulting from
rheumatic disorders.
LYVISPAH will be available through both specialty and retail
channels upon launch, with a full patient support program. The
Company has partnered with BlinkRx, a patient access company, to
support patients on LYVISPAH with services, such as free home
delivery.
According to IQVIA®, U.S. annual sales for baclofen for the 12
months ended March 2022 were $130 million.
INDICATION
- LYVISPAH (baclofen) oral granules is indicated for the
treatment of spasticity resulting from multiple sclerosis,
particularly for the relief of flexor spasms and concomitant pain,
clonus, and muscular rigidity.
- LYVISPAH may also be of some value in patients with spinal cord
injuries and other spinal cord diseases.
Limitations of Use: LYVISPAH is not indicated in the
treatment of skeletal muscle spasm resulting from rheumatic
disorders.
Contraindication: LYVISPAH is contraindicated in patients
with hypersensitivity to baclofen.
Warnings and Precautions
- Abrupt discontinuation of baclofen, regardless of the cause,
has resulted in adverse reactions that include hallucinations,
seizures, high fever, altered mental status, exaggerated rebound
spasticity, and muscle rigidity, that in rare cases has advanced to
rhabdomyolysis, multiple organ-system failure, and death.
Therefore, reduce the dosage slowly when LYVISPAH is discontinued,
unless the clinical situation justifies a rapid withdrawal.
- Neonatal withdrawal can occur; gradually reduce the dosage and
discontinue LYVISPAH before delivery.
- LYVISPAH can cause drowsiness and sedation. Patients should
avoid the operation of automobiles or other dangerous machinery
until they know how the drug affects them. Advise patients that the
central nervous system effects of LYVISPAH may be additive to those
of alcohol and other CNS depressants.
- LYVISPAH can cause exacerbation of the following: psychotic
disorders, schizophrenia, or confusional states; autonomic
dysreflexia; epilepsy. Use with caution in patients with these
conditions.
- LYVISPAH should be used with caution in patients who have had a
stroke.
Adverse Reactions
- The most common adverse reactions (>1%) in patients treated
with baclofen for spasticity are drowsiness, dizziness, weakness,
nausea, confusion, hypotension, headache, insomnia, constipation,
urinary frequency, and fatigue.
Drug Interactions
- LYVISPAH can cause CNS depression, including drowsiness and
sedation, which may be an additive when used concomitantly with
other CNS depressants or alcohol.
Use in Specific Populations
- Pregnancy: There are no adequate data on the developmental
risks associated with the use of LYVISPAH in pregnant women.
LYVISPAH should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
- Lactation: Nursing mothers should exercise caution, as oral
baclofen has been shown to pass into milk at therapeutic doses.
Withdrawal symptoms can occur in breastfed infants when maternal
administration of LYVISPAH is stopped, or when breastfeeding is
stopped.
- Pediatrics: Safety and effectiveness in pediatric patients
below the age of 12 have not been established.
- Elderly Patients: In general, dose selection for an elderly
patient should be cautious, usually starting at the low end of the
dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease of
other drug therapy.
- Renal Impairment: Because baclofen is primarily excreted
unchanged through the kidneys, LYVISPAH should be given with
caution to patients with renal impairment, and it may be necessary
to reduce the dosage.
For more information, refer to LYVISPAH prescribing information,
located here.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully integrated essential medicines company.
We make healthy possible through the development, manufacturing,
and distribution of generic and specialty pharmaceuticals,
primarily within the United States. The Company has a diverse
portfolio of over 250 products in its Generics segment and is
expanding across a broad range of complex products and therapeutic
areas, including injectables and biosimilars. In its Specialty
segment, Amneal has a growing portfolio of branded pharmaceutical
products focused primarily on central nervous system and endocrine
disorders, with a pipeline focused on unmet needs. Through its
AvKARE segment, the Company is a distributor of pharmaceuticals and
other products for the U.S. federal government, retail, and
institutional markets. For more, please visit www.amneal.com.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are
not historical facts, may be forward-looking statements (as defined
in the U.S. Private Securities Litigation Reform Act of 1995). Such
forward-looking statements include statements about LYVISPAH and
its potential benefits, management’s intentions, plans, strategies,
beliefs, expectations or forecasts regarding LYVISPAH and other
products, including among other things: product research and
development; discussions of future operations; expected operating
results and financial performance, including projected revenues
from LYVISPAH and other products; the Company’s strategy for
growth; regulatory approvals and actions; market position,
saturation, and expenditures. Words such as “plans,” “expects,”
“will,” “anticipates,” “estimates” and similar words are intended
to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. These forward-looking statements are based on current
expectations of future events. If the underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of the Company.
Such risks and uncertainties include, but are not limited to:
our ability to successfully develop, license, acquire and
commercialize new products on a timely basis, including the risks
and uncertainties inherent in launching and commercializing
LYVISPAH; the competition we face in the pharmaceutical industry in
general, including from brand and generic drug product companies,
and the impact of that competition on our ability to execute on
pricing strategies; our ability to obtain exclusive marketing
rights for our products; our ability to manage our growth through
acquisitions and otherwise; our dependence on the sales of a
limited number of products for a substantial portion of our total
revenues; the continuing trend of consolidation of certain customer
groups; our dependence on third-party suppliers and distributors
for raw materials for our products and certain finished goods and
any associated supply chain disruptions; litigation outcomes,
including intellectual property disputes or other legal efforts to
prevent or curb Amneal’s ability to sell its products; the impact
of severe weather; the impact of the ongoing COVID-19 pandemic;
risks related to federal regulation of arrangements between
manufacturers of branded and generic products; our reliance on
certain licenses to proprietary technologies from time to time; the
significant amount of resources we expend on research and
development; the risk of product liability and other claims against
us by consumers and other third parties; risks related to changes
in the regulatory environment, including U.S. federal and state
laws related to healthcare fraud abuse and health information
privacy and security and changes in such laws; changes to FDA
product approval requirements; the impact of healthcare reform and
changes in coverage and reimbursement levels by governmental
authorities and other third-party payers; our dependence on
third-party agreements for a portion of our product offerings; the
impact of global economic conditions, including any economic
effects stemming from adverse geopolitical events, an economic
downturn and inflation rates; our ability to identify, make and
integrate acquisitions or investments in complementary businesses
and products on advantageous terms; our substantial amount of
indebtedness and our ability to generate sufficient cash to service
our indebtedness in the future, and the impact of interest rate
fluctuations on such indebtedness; our obligations under a tax
receivable agreement may be significant; and the high concentration
of ownership of our Class A Common Stock and the fact that we are
controlled by the Amneal Group. The forward-looking statements
contained herein are also subject generally to other risks and
uncertainties that are described from time to time in the Company’s
filings with the Securities and Exchange Commission, including
under Item 1A, “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K and in its subsequent reports on Forms 10-Q and
8-K. Investors are cautioned not to place undue reliance on any
such forward-looking statements, which speak only as of the date
they are made. Forward-looking statements included herein speak
only as of the date hereof and we undertake no obligation to revise
or update such statements to reflect the occurrence of events or
circumstances after the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20220601005309/en/
Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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