- IPX203 could offer people living with Parkinson’s disease a
longer duration of symptom control with less frequent dosing
compared to IR CD/LD treatment
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA)
date of June 30, 2023.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the
U.S. Food and Drug Administration (FDA) has accepted for review the
New Drug Application (NDA) for IPX203 for the treatment of
Parkinson’s disease (PD). IPX203 is a novel, oral formulation of
carbidopa/levodopa (CD/LD) extended-release capsules.
“The FDA filing acceptance of IPX203 marks another important
milestone for Amneal as we strive to improve the lives and care of
people living with Parkinson’s disease,” said Gustavo Pesquin,
Chief Commercial Officer, Amneal Specialty. “We look forward to
engaging in conversations with the FDA as we advance the
application. We believe the data in our RISE-PD study supports the
important benefit IPX203 can offer to this community by providing
longer duration of symptom control with the benefit of fewer
doses.”
CD/LD has been the leading treatment for PD since the 1970s.
Data from the pivotal Phase 3 RISE-PD clinical trial found that
IPX203’s extended-release formulation offers significantly more
“Good On” time, as well as significantly less “Off” time, compared
to immediate-release CD/LD, even when dosed less frequently.
“Amneal aims to provide people living with Parkinson’s disease
effective treatments that allow them to live their lives with less
concern about their mobility and symptoms, and more freedom to
choose how to spend their time,” said Pesquin. “We are pleased that
IPX203 has the potential to address this need by extending periods
when symptoms are better controlled, with less frequent
dosing.”
The FDA assigned a Prescription Drug User Fee Act (PDUFA) date
of June 30, 2023 to complete its evaluation of the NDA.
About the RISE-PD Trial
The multicenter, randomized, double-blind, double-dummy,
active-controlled, parallel-group RISE-PD trial evaluated the
efficacy and safety of IPX203 CD/LD extended-release capsules
compared with immediate-release CD/LD in the treatment of people
living with PD who have motor fluctuations.
The trial consisted of a 3-week, open-label immediate-release
CD/LD dose adjustment period and a 4-week, open-label period for
conversion to IPX203. This was followed by a 13-week double-blind
treatment period in which patients were randomized 1:1 to receive
either IPX203 (with matching immediate-release CD/LD placebo) or
immediate-release CD/LD (with matching IPX203 placebo). The
baseline for all endpoints was Week 7 (Visit 4), which occurred
pre-randomization. The most common adverse reaction (incidence ≥ 3%
and greater than immediate-release CD-LD) was nausea (4.3%).
The primary endpoint of the trial assessed the change from
baseline in “Good On” time in hours per day at the end of the
double-blind treatment period (Week 20 or early termination). “Good
On” time is defined as the sum of “On” time without dyskinesia and
“On” time with non-troublesome dyskinesia. Secondary endpoints
assessed the change from baseline in “Off” time in hours per day,
proportion of patients who were either “much improved” or “very
much improved” in Patients' Global Impression of Change (PGI-C)
scores, change from baseline in the Movement Disorder Society -
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
score, and the change from baseline in sum of MDS-UPDRS Parts II
and III scores.
The trial was conducted at 105 clinical sites in the U.S. and in
European countries, including Czechia, France, Germany, Italy,
Poland, Spain and the United Kingdom. The study randomized 506
patients who had received a PD diagnosis at age 40 or older. The
study design was reviewed by the FDA and conducted pursuant to a
Special Protocol Assessment. A nine-month safety extension study
was completed earlier this year (2022).
About IPX203
IPX203 is a novel, oral formulation of CD/LD extended-release
capsules designed for the treatment of Parkinson’s disease. IPX203
contains immediate-release granules and extended-release beads. The
IR granules consist of CD and LD, with a disintegrant polymer to
allow for rapid dissolution. The ER beads consist of LD, coated
with a sustained release polymer to allow for slow release of the
drug, a mucoadhesive polymer to keep the granules adhered to the
area of absorption longer, and an enteric coating to prevent the
granules from disintegrating prematurely in the stomach. This
formulation is distinct from RYTARY® (carbidopa/levodopa)
extended-release capsules, Amneal’s extended-release CD/LD
treatment for PD approved by the U.S. FDA in 2015.
About Parkinson’s Disease
Parkinson’s disease (PD) has become the fastest growing
neurological disorder worldwide, with approximately 1 million
people diagnosed in the U.S.1,2 It is a progressive disorder of the
central nervous system (CNS) that affects dopamine-producing
neurons in the brain that affect movement.
PD is characterized by slowness of movement, stiffness, resting
tremor and impaired balance.3 While PD is not considered a fatal
disease, it is associated with significant morbidity and
disability.4 The average age at diagnosis for people with PD is 60;
as people live longer, the number of people living with PD is
predicted to grow significantly over the coming decades.1,5
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.
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Certain statements contained herein, regarding matters that are
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well as its strategy for growth; product development and launches;
the successful commercialization and market acceptance of new
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“will,” “anticipates,” “estimates,” and similar words are intended
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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; the competition we
face in the pharmaceutical industry, in general, specifically from
brand and generic drug product companies, and the impact of that
competition on our ability to set prices; our ability to obtain
exclusive marketing rights for our products; 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 ability to manage our
growth through acquisitions and otherwise; our dependence on the
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global economic conditions, including any economic effects stemming
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and rising interest rates; our ability to identify, make and
integrate acquisitions or investments in complementary businesses
and products on advantageous terms; 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
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filings with the Securities and Exchange Commission, including
under Item 1A, “Risk Factors” in the Company’s most recent Annual
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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.
References:
- Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
- Marras et al. NPJ Parkinsons Dis. 2018;4:21.
- NINDS. Parkinson’s disease: challenges, progress, and promise.
Reviewed August 2019. Accessed April 16, 2021.
- Data Monitor: Gibrat et al., 2009; Goldenberg, 2008;
Muangpaisan et al., 2009; Pringsheim et al., 2014.
- John Hopkins Medicine. Young-Onset Parkinson’s disease.
Accessed August 17, 2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20221109005842/en/
Investor Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com Media Ana Fullmer Group Director,
Media and Engagement, Real Chemistry afullmer@realchemistry.com
Amneal Medical Affairs 888-990-AMRX (2679)
askamrx@amneal.com
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