CHAPEL HILL, N.C., Aug 22, 2002 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN)
announced today preliminary results of a Phase IIIb trial of migraine patients
with an intolerance to triptans or with cardiovascular risk factors that would
warrant cautious use of triptans.
Results of the study indicated that MT 100 provided superior sustained pain
relief and two-hour pain relief compared to placebo. MT 100 is an oral tablet
designed for first-line migraine therapy.
The double-blind, randomized, placebo-controlled study enrolled 238 patients
across 19 centers in the United States and was designed to examine the effects
of MT 100 compared to placebo in migraine patients with an intolerance to
triptans (47% of the study population) and/or with cardiovascular risk factors
(88% of the study population). Also, 35% of the study population had reportedly
used a narcotic for their migraine attacks before participating in the study,
and two-thirds of those experienced adverse events that limited their normal
activity following narcotic usage.
The preliminary analysis of the data indicated that MT 100 provided
statistically superior sustained pain relief compared to placebo. Of the
patients taking MT 100, 41% reported sustained pain relief versus 20% for
placebo. Sustained pain relief was defined as patients achieving pain relief
within two hours of dosing and neither relapsing nor using rescue medicine over
the next 22 hours.
Additionally, MT 100 provided statistically superior two-hour pain relief
compared to placebo. Of the patients taking MT 100, 54% reported two-hour pain
relief versus 33% for placebo. Regarding secondary endpoints, MT 100 had a
statistically significant lower incidence of nausea and sensitivity to sound
within 3 hours of dosing, and a statistically significant lower incidence of
sensitivity to light within 4 hours of dosing compared to placebo. As seen in
previous studies, MT 100 was well tolerated with no serious adverse or
cardiovascular events reported in the study.
"Although we believe MT 100 will be best suited as first-line therapy for
patients needing prescription migraine medicine, these data indicate its
usefulness in these two populations of difficult-to-treat patients," said John
R. Plachetka, Pharm.D., chairman, president and chief executive officer of
POZEN is a pharmaceutical development company committed to building a portfolio
of products with significant commercial potential in select therapeutic areas.
POZEN's initial focus is on developing products for migraine therapy, a global
market expected to exceed $2.8 billion this year. The company's common stock is
traded on The Nasdaq Stock Market under the symbol "POZN."
Statements included in this press release that are not historical in nature are
"forward-looking statements" within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995. You should be aware
that our actual results could differ materially from those contained in the
forward-looking statements, which are based on management's current expectations
and are subject to a number of risks and uncertainties, including, but not
limited to, our failure to successfully commercialize our products; costs and
delays in the development and FDA approval of our products; our inability to
enter into or maintain, and the risks resulting from our dependence upon,
collaboration or contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution of our
products; competitive factors; our inability to protect our patents or
proprietary rights and obtain necessary rights to third party patents and
intellectual property to operate our business; our inability to operate our
business without infringing the patents and proprietary rights of others;
general economic conditions; the failure of our products to gain market
acceptance; our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry practice; and
one-time events, including those discussed herein and in our Quarterly Report on
Form 10-Q for the quarterly period ended June 30, 2002 under "Management's
Discussion and Analysis of Financial Condition and Results of Operations." We do
not intend to update any of these factors or to publicly announce the results of
any revisions to these forward-looking statements.
POZEN is on the Internet at www.pozen.com
Chief Financial Officer
Director, Investor Relations