-
First presentation at a medical meeting of topline results and post
hoc analysis
-
Positive topline results were previously announced in August
2021
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that
results from the pivotal Phase 3 RISE-PD clinical trial evaluating
the novel investigational extended-release CD/LD formulation,
IPX-203, in Parkinson’s disease patients with motor fluctuations,
will be presented at the 2022 American Academy of Neurology (AAN)
Annual Meeting, April 2-7, in Seattle, WA.
The data are being presented for the first time at AAN and are
consistent with the positive topline results announced last year.
Amneal plans to submit a New Drug Application for IPX-203 in the
second quarter of 2022. Amneal’s abstracts at AAN will include:
A Phase 3 Trial of IPX-203 vs. Immediate Release CD/LD in
Parkinson’s Disease Patients with Motor Fluctuations (RISE-PD);
Hauser, R. et al.
Session S16: Movement Disorders: PD Biomarkers and Clinical
Trials; Monday, April 4; 5:18 PM PT
- Lead investigator Robert A. Hauser, M.D., will present the
topline results of the Phase 3 RISE-PD clinical trial as part of a
scientific platform session at the AAN Annual Meeting in Seattle,
WA.
- In the trial, IPX-203 showed statistically significant
improvement in “Good On” time compared to immediate release CD/LD,
when dosed on average three times a day compared to five times a
day for immediate release CD/LD.
Duration of Benefit Per Dose: Post Hoc Analysis of “Good On”
Time Per Dose for IPX-203 vs. Immediate Release CD/LD in the
RISE-PD Phase 3 Trial; Hauser, R. et al.
Session P10: Movement Disorders: Trials 2; Tuesday, April 5;
8:00 – 9:00 AM PT
- Post hoc analysis of Least Squares Mean difference at end of
study (week 20) showed that IPX-203 provided 1.55 more hours of
“Good On” time per dose versus immediate release CD/LD,
representing a 70% increase.
“The findings from a post hoc analysis of the RISE-PD trial
indicated that IPX-203 may offer patients more ‘Good On’ time per
dose, compared to immediate-release CD/LD. Increasing the amount of
‘Good On’ time, if confirmed, can reduce disruptions caused by
troublesome dyskinesia and provide more consistent symptom control
throughout the day,” 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 so pleased to be back in-person at the 2022 AAN Annual
Meeting where we will be presenting data from the Phase 3 clinical
trial on IPX-203,” said Richard D’Souza, PhD, Senior Vice
President, R&D for Amneal Specialty. “Amneal’s presentations at
AAN underscore our commitment to advancing research and treatment
for patients living with Parkinson’s disease and the communities
that support them. We are encouraged by the trial findings, as they
indicate that IPX-203 could offer patients and the physicians that
treat them another safe and effective treatment option with reduced
dose frequency.”
The 2022 AAN abstracts are available here.
About the Pivotal Phase 3 RISE-PD Trial
The multicenter, randomized, double-blind, double-dummy,
active-controlled, parallel-group RISE-PD trial evaluated the
efficacy and safety of IPX-203 CD/LD extended-release capsules
compared with immediate-release 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 IPX-203 (with matching immediate-release CD/LD placebo) or
immediate-release CD/LD (with matching IPX-203 placebo). Baseline
for all endpoints was Week 7 (Visit 4), which occurred
pre-randomization.
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 is
ongoing.
About IPX-203
IPX-203 is a novel, oral formulation of CD/LD extended-release
capsules designed for patients with Parkinson’s disease who have
motor fluctuations. 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, coated with a controlled-release (CR)
polymer to allow for slow release of the drug, a mucoadhesive
polymer to keep the granules anchored 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 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 approximately 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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version on businesswire.com: https://www.businesswire.com/news/home/20220324005094/en/
Investor Contact Anthony DiMeo Senior Director, Investor
Relations anthony.dimeo@amneal.com
Media Contact 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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