HAYWARD, Calif.--(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.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
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 of management. Such
statements are based on current expectations and involve a number of
known and unknown risks and uncertainties that could cause the Company’s
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the effect of current economic conditions on the
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 filed with the Securities and Exchange Commission.
Forward-looking statements speak only as to 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.
Source: Impax Laboratories, Inc.