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▎WuXi AppTec content team editor
Today, Amneal Pharmaceuticals announced that the U.
S.
Food and Drug Administration (FDA) has accepted its new
drug application for Parkinson's disease.
Once approved, the new drug is expected to bring new treatment options
to patients with Parkinson's disease.
As the world's second largest neurodegenerative disease, Parkinson's disease affects the lives of nearly 10 million people around the world, and the burden of disease is increasing with the aging of the world, according to the latest data from the World Health Organization in June this year, the number of Parkinson's disease cases has nearly doubled in the past 25 years, and the disability and death caused by the disease are also increasing, faster than any other neurological disease
。
To better treat Parkinson's disease, we need more innovative drugs
.
IPX203 brought by Amneal is one such innovative therapy
.
This is a novel oral carbidopa/levodopa (CD/LD) sustained-release capsule containing immediate- and sustained-release granules, as well as mucosal attachment polymers that provide rapid absorption and maximize
levodopa absorption.
Last August, the therapy achieved positive results
in a Phase 3 clinical trial.
The overall results of this multicenter, randomized, double-blind, active-drug-controlled Phase 3 clinical trial enrolling a total of 506 PD patients over 40 years of age showed statistically significant symptom improvement
in IPX-203 compared with the active control.
When comparing changes from baseline between the two trial groups, IPX-203 treatment resulted in a "Good On" time 0.
53 hours longer than the active control group (p=0.
0194).
In addition, IPX-203 resulted in a significant reduction in "Off" time (-0.
48 h, p=0.
0252)
compared to the active control group.
Based on these results, the company submitted a marketing application to the U.
S.
FDA this year, which was accepted
today.
The FDA is expected to respond
by June 30 next year.
If approved, it would bring new hope
to Parkinson's patients.
"The FDA's acceptance of the marketing application for IPX203 is another important milestone
for Amneal.
" The company commented in a press release
.
In the future, the company also plans to maintain communication with the FDA to promote the follow-up process
of this drug.
WuXi AppTec provides integrated, end-to-end new drug development and manufacturing services to the global biopharmaceutical industry, covering chemical drug development and manufacturing, biological research, preclinical testing and clinical trial development, cell and gene therapy development, testing and manufacturing
.
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