Impax Pharmaceuticals Completes Enrollment in ADVANCE-PD Phase III Trial of IPX066 in Parkinson’s Disease
August 25 2010 - 9:00AM
Business Wire
Impax Pharmaceuticals, the brand products division of Impax
Laboratories, Inc. (NASDAQ: IPXL), today announced that it has
completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a
multinational Phase III trial of its late-stage product IPX066 in
advanced Parkinson’s disease (PD) patients with motor fluctuations.
IPX066 is an investigational extended release carbidopa-levodopa
product intended to rapidly achieve and sustain effective blood
concentrations of levodopa, potentially improving PD clinical
symptom management. This is the second of two pivotal Phase III
studies designed to support a new drug application of IPX066 in
Parkinson’s disease.
“We are very pleased to have completed enrollment in ADVANCE-PD,
the second pivotal trial planned for submission to support our
approval in Parkinson’s disease,” stated Michael Nestor, president
of Impax Pharmaceuticals. “This achievement by our dedicated
R&D team is an important milestone for IPX066 and for Impax
Pharmaceuticals as we plan for potential product launch. We look
forward to providing the top line results for this trial in the
first half of 2011 and continue to progress toward filing the new
drug application in the fourth quarter of 2011.”
The ADVANCE-PD study (www.advance-pd.com) is a Phase III study
of the safety and efficacy of IPX066 versus immediate-release (IR)
carbidopa-levodopa (CD-LD) in advanced PD patients with motor
fluctuations. The 22-week trial is being conducted in North America
and Europe, and the primary endpoint is percentage of “off” time
during waking hours. The trial exceeded its enrollment objective
and results are expected in the first half of 2011.
The ADVANCE-PD trial in patients with advanced PD complements
the APEX-PD Study (www.apex-pd.com) being conducted in
levodopa-naïve PD patients, which finished enrollment earlier this
year and is ongoing. The ADVANCE-PD and APEX-PD trials follow the
earlier announced successful Phase II study of IPX066 in
Parkinson’s patients.
About IPX066 and Parkinson’s Disease (PD)
IPX066 is an investigational extended release carbidopa-levodopa
product intended to produce a fast and sustained concentration of
levodopa, potentially improving PD clinical symptom management.
IPX066 has the potential to offer improved and more reliable
control of PD symptoms, leading to clinically meaningful reductions
in “off” time, a key objective in the management of PD. “Off-time”
is the functional state when patients’ medication effect has worn
off and there is a return of Parkinson symptoms. In addition,
IPX066 extended release formulation is designed to reduce dosing
frequency, enhancing patient convenience.
Parkinson’s disease is a chronic neurodegenerative movement
disorder affecting an estimated one million people in the U.S.
About $1 billion per year is spent on medications to treat PD in
the U.S.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded
products. Impax markets its generic products through its Global
Pharmaceuticals division and markets its branded products through
the Impax Pharmaceuticals division. Additionally, where
strategically appropriate, Impax has developed marketing
partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a
full range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web
site at: www.impaxlabs.com.
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