- IPX203 demonstrated statistically significant
improvement in daily “Good On” time compared to optimized IR CD/LD,
with fewer daily doses
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that
JAMA Neurology has published results from the RISE-PD clinical
study assessing the efficacy and safety of IPX203 versus optimized
immediate-release carbidopa/levodopa (IR CD/LD) for the treatment
of Parkinson’s disease (PD). The study met its primary and
secondary endpoints finding that IPX203 provided more hours of
“Good On” time per day, less “Off” time per day, and more “Good On”
time per dose than optimized IR CD/LD, even when dosed less
frequently. “Good On” time is defined as the sum of “On” time
without dyskinesia and “On” time with non-troublesome dyskinesia.
The manuscript titled, “IPX203 vs Immediate-Release
Carbidopa-Levodopa for the Treatment of Motor Fluctuations in
Parkinson Disease,” was published online on August 14, 2023.
“When it comes to Parkinson’s disease, the community is looking
for treatments that provide a longer duration of benefit per dose
of LD and simplified dosing regimens,” said Robert A. Hauser, M.D.,
Professor of Neurology at the University of South Florida and
Director of the Parkinson's Disease and Movement Disorders Center.
“We are very encouraged by the recently published data in JAMA
Neurology which illustrate how IPX203 could fill this need,
potentially leading to a better patient experience, more ‘Good On’
time, and improved patient adherence.”
RISE-PD was a 20-week, randomized, double-blind, double-dummy,
active-controlled, phase 3 clinical trial. A total of 630 patients
(mean age 66.5 years; 62.9% men) were enrolled and 506 patients
were randomly assigned to receive IPX203 (n = 256) or
immediate-release carbidopa-levodopa (n = 250). The results
published in JAMA Neurology show that treatment with IPX203
demonstrated statistically significant improvement in daily “Good
On” time with fewer doses of IPX203 compared with immediate-release
carbidopa-levodopa (least squares mean, 0.53 hours; 95% CI,
0.09-0.97), with IPX203 dosed a mean three times per day vs 5 times
per day for immediate-release carbidopa-levodopa.
Additionally, “Good On” time per dose increased by 1.55 hours
with IPX203 compared with immediate-release carbidopa-levodopa (95%
CI, 1.37-1.73). IPX203 was well tolerated. The most frequently
reported TEAEs among patients treated with IPX203 were nausea (11
[4.3%]), anxiety (7 [2.7%]), and dizziness (6 [2.3%]). The most
frequently reported TEAEs among patients treated with IR CD-LD were
fall (9 [3.6%]), urinary tract infection (8 [3.2%]), and back pain
(7 [2.8%]).
“Our commitment to people living with Parkinson’s disease, and
advancing treatments designed to provide longer-lasting duration of
benefit and simpler medication regimens, remains unchanged,” said
Chirag and Chintu Patel, Co-Chief Executive Officers. “The data
published in JAMA Neurology illustrate that IPX203 may provide
sustained benefit throughout the day, with more ‘Good On’ time with
fewer daily doses – which could represent an important advance for
people living with Parkinson’s disease.”
Following a Complete Response Letter (CRL) from the FDA earlier
this year on its New Drug Application for IPX203, Amneal has shared
a reanalysis of the data and requested a Type A meeting as it looks
to bring the treatment to market.
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 IR CD/LD in the treatment of patients 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 IPX-203. 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)
optimized IR CD/LD (with matching IPX-203 placebo). 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
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 in 2022.
About IPX203
IPX203 is a novel, oral formulation of CD/LD extended-release
capsules designed for the treatment of Parkinson’s disease. IPX-203
contains immediate-release granules and extended-release coated
beads. The IR granules consist of CD and LD, with a disintegrant
polymer to allow for rapid dissolution. The ER beads consist of LD,
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
patients 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 patients with PD is
60; as people live longer, the number of patients 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 global pharmaceuticals
company. We make healthy possible through the development,
manufacturing, and distribution of a diverse portfolio of
approximately 270 pharmaceutical products, primarily within the
United States. In its Generics segment, the Company is expanding
across a broad range of complex product categories and therapeutic
areas, including injectables and biosimilars. In its Specialty
segment, Amneal has a growing portfolio of branded pharmaceuticals
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 information, please visit
www.amneal.com.
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Forward-looking statements included herein speak only as of the
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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/20230824209527/en/
Investor Contact Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Media Contact Rachel St. Martin Managing Director, Media
and Engagement, Real Chemistry rstmartin@realchemistry.com
Amneal Medical Affairs 888-990-AMRX (2679)
askamrx@amneal.com
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