Impax Pharmaceuticals Initiates Phase IIb Trial of IPX159 in Restless Legs Syndrome
December 19 2011 - 11:30AM
Business Wire
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL), announced that it has initiated
a Phase IIb trial of its drug candidate IPX159 in patients with
moderate to severe Restless Legs Syndrome (RLS).
“We are pleased to advance IPX159 to this Phase IIb study, which
will help establish its clinical profile in moderate to severe RLS
patients. We look forward to reporting the results from this study
and providing an update on the program in mid-2013,” said Suneel
Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.
The Phase IIb study is a multicenter, randomized, double-blind,
placebo-controlled, safety and efficacy study to evaluate IPX159 in
the treatment of moderate to severe RLS. The trial is expected to
randomize approximately 120 adult subjects who will receive either
IPX159 or placebo and will be treated for up to 11 weeks. The trial
will be conducted at multiple sites in North America. The primary
endpoint is the International Restless Legs Syndrome Study Group
(IRLSSG) Rating Scale.
About IPX159
IPX159 is an oral controlled-release formulation of a small
molecule that has an established pharmacological and safety profile
for non-RLS use outside the U.S. and may represent a novel
mechanism of action in RLS. Impax has previously completed a proof
of concept study with the molecule in RLS patients.
About Restless Legs Syndrome
Restless Legs Syndrome (RLS) is a condition characterized by an
irresistible urge to move ones’ limbs, most commonly the legs, to
stop uncomfortable sensations. RLS symptoms generally worsen in the
evening, are made worse by rest or inactivity, and commonly cause
insomnia and involuntary leg movements during sleep. There are
approximately 25 million RLS sufferers in the US.
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 is
headquartered in Hayward, California, with a full range of
capabilities located 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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To the extent any statements made in this news release contain
information that is not historical, including the statements under
the heading “2011 Financial Outlook,” these statements are
forward-looking in nature and express the beliefs and expectations
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Company’s industry, business, financial position and results of
operations, the ability to maintain an effective system of internal
control over financial reporting, fluctuations in revenues and
operating income, the ability to successfully develop and
commercialize pharmaceutical products, reductions or loss of
business with any significant customer or a reduction in sales of
any significant product, the impact of competition, the ability to
sustain profitability and positive cash flows, any delays or
unanticipated expenses in connection with the operation of the
Taiwan facility, the effect of foreign economic, political, legal
and other risks on operations abroad, the uncertainty of patent
litigation, consumer acceptance and demand for new pharmaceutical
products, the difficulty of predicting Food and Drug Administration
filings and approvals, the inexperience of the Company in
conducting clinical trials and submitting new drug applications,
the ability to successfully conduct clinical trials, reliance on
alliance and collaboration agreements, the availability of raw
materials, the ability to comply with legal and regulatory
requirements governing the pharmaceuticals and healthcare
industries, the regulatory environment, the ability to protect the
Company’s intellectual property, exposure to product liability
claims and other risks described in the Company’s periodic reports
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becomes available, future developments occur or otherwise.
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