>>CHAPEL HILL, N.C.--(BUSINESS WIRE)--June 23, 2003-- POZEN Inc. (NASDAQ: POZN - News), a pharmaceutical company developing therapeutic advancements in a cost effective manner, announced today the presentation of data from three posters at the 45th Annual Scientific Meeting of The American Headache Society (AHS) in Chicago. One of the presentations highlighted data from a Phase III study demonstrating that MT 300 is effective in providing sustained pain relief for the acute treatment of migraine. MT 300 is being developed as a new, improved formulation of dihydroergotamine (DHE) in a convenient pre-filled syringe that is suitable for at-home use. Top line results from the studies were announced by POZEN in press releases issued on July 22, 2002 and October 4, 2002.
"As migraine attacks differ in severity, so should treatment options," stated John R. Plachetka, Pharm.D., chairman, president and chief of executive officer of POZEN. "At POZEN, we are currently developing three product candidates that are designed to treat the full range of migraine attacks. We are excited to present data on MT 300 and believe it has the potential to offer patients a convenient and effective injectable therapy for their migraine attacks." POZEN submitted a New Drug Application for MT 300 to the U.S. Food and Drug Administration in December 2002.
The Company's three presentations were:
Abstract# F17
Title: A New Formulation of Dihydroergotamine (DHE) is Effective
for Sustaining Relief in the Acute Treatment of Migraine.
The results of two randomized double-blind, placebo-controlled,
multicenter studies performed in patients with acute migraine attacks
showed that MT 300 was well tolerated and significantly more effective
for the sustained relief of migraine pain than placebo. Furthermore,
MT 300 provided a convenient and easy to use package for patient
self-administration.
Abstract# F9
Title: Defining and Analyzing Meaningful Relief in Clinical Trials
of Acute Migraine Headache.
Efficacy data obtained from subjects who treated severe migraine
headaches with one of three different treatments were used as example
data to illustrate how different pain measures can be interpreted. The
presentation concluded that while measures of pain response at 2 hours
allow some treatments to appear effective, only sustained measures of
pain responses incorporated the use of rescue medication and pain
relapse over time. Sustained pain response measures (particularly pain
free) are most closely aligned with patients' expectations of
treatment success.
Abstract# F21
Title: Barriers to the Use of Oral Triptans by Patients Diagnosed
with Migraine Headaches. The findings presented in this study were
derived from a usage and attitude study with migraineurs designed to
investigate current migraine treatment use and satisfaction with
existing therapies. The study concluded that efficacy, side effects,
and cost are barriers to using oral triptans for migraine treatment.
About Migraine
Migraine afflicts approximately 28 million people in the United States alone, of which roughly three out of four migraine sufferers are women. Migraine attacks can last from 4 hours to 72 hours and are typically characterized by sharp pulsating pain on one side of the head, nausea, and extreme sensitivity to light and sound. While the precise mechanism of migraine is unknown, researchers believe migraine attacks are caused by acute inflammation surrounding selected vessels in the head. The average migraine sufferer experiences the first attack during the early teen years, and the attacks generally continue throughout adulthood. <<
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Cheers, Tuck |
