Impax Pharmaceuticals Initiates Second Phase III Trial of IPX066 in Parkinson’s Disease
October 26 2009 - 9:09AM
Business Wire
Impax Pharmaceuticals, the brand products division of Impax
Laboratories, Inc. (NASDAQ:IPXL), today announced that it has
initiated a multinational Phase III trial of its late-stage drug
candidate IPX066 in advanced Parkinson’s disease (PD) patients.
IPX066 is an investigational extended release carbidopa-levodopa
product intended to rapidly achieve and then sustain effective
blood concentrations of levodopa, potentially improving PD clinical
symptom management. This is the second of two Phase III studies
designed to support marketing approval of IPX066 in Parkinson’s
disease. Impax Pharmaceuticals previously reported in June the
initiation of the first Phase III study of IPX066 in naïve PD
patients.
Michael Nestor, divisional president of Impax Pharmaceuticals
said: “We are extremely pleased to start the second Phase III study
for IPX066. This trial in patients with advanced PD includes
significant input from the FDA into the study design.” He added,
“Impax Pharmaceuticals looks forward to the successful development
of IPX066 and bringing its potential benefits to physicians who
treat Parkinson’s and their patients as quickly as possible.”
About the ADVANCE-PD Phase III Study
- The ADVANCE-PD study
(www.advance-pd.com) will evaluate the safety and efficacy of
IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in
advanced PD patients with motor fluctuations.
- The trial is expected to enroll
approximately 420 subjects who will be on treatment for
approximately 22 weeks.
- The trial will be conducted at
multiple sites in North America and Europe.
- The primary endpoint is
percentage of “off” time during waking hours.
- Additional endpoints include
total “off” time, total “on” time with no troublesome dyskinesias,
Unified Parkinson’s Disease Rating Scale (UPDRS) and clinician and
patient reported outcome measures, including quality of life
scales.
The ADVANCE-PD trial in patients with advanced PD complements
the APEX-PD Study (www.apex-pd.com), which commenced in
April 2009 and is currently enrolling levodopa-naïve PD patients.
APEX-PD is a randomized, double blind, placebo-controlled study to
evaluate the safety and efficacy of IPX066 and is being conducted
in North America and Europe. 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 and Philadelphia
facilities. For more information, please visit the Company's Web
site at: www.impaxlabs.com.
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To the extent any statements made in this news release contain
information that is not historical, these statements are
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for new pharmaceutical products; the impact of competitive products
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conducting clinical trials and submitting new drug applications;
reliance on key alliance agreements; the availability of raw
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detailed from time to time in our filings with the Securities and
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the date on which they are made, and Impax undertakes no obligation
to update publicly or revise any forward-looking statement,
regardless of whether new information becomes available, future
developments occur or otherwise.
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