FDA Approves VioxxR (Rofecoxib) for the

[Guest guest]

FDA Approves Vioxx® (Rofecoxib) for the

Acute Treatment of

Migraine in Adults

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256E690066E2CD

Your shorter link

is: http://makeashorterlink.com/?R2A752FF7

First and Only COX-2

Specific Inhibitor Approved to Relieve Pain and

Symptoms of Migraine

Attacks

WHITEHOUSE STATION,

NJ -- April 1, 2004 -- Starting today, there is a

new pain-relieving

option to help the millions of Migraine sufferers in

the United States. Vioxx® ( Rofecoxib), Merck & Co.,

Inc.'s once-daily

Arthritis and Pain

Medicine, received approval from the Food and Drug

Administration (FDA)

for the Acute Treatment of Migraine attacks with

or without Aura (the

warning of an oncoming Migraine attack) in adults.

Vioxx® is the first

and only COX-2 specific Inhibitor approved to

relieve Migraine

Pain and associated Migraine Symptoms.

" The pain from

Migraines can be excruciating, and can last for several

hours or days -

people with Migraines know how devastating they can be, "

said clinical

investigator Silberstein, M.D., professor of

Neurology, Jefferson University Hospital School of Medicine and

director, Jefferson Headache Center, Philadelphia. " Studies have shown

that just one Vioxx®

relieved Migraine Headache pain for most patients

within two hours, a

standard measurement for evaluating the efficacy of

Migraine

Treatments. "

Vioxx® offers a

powerful new treatment option for the estimated 28

million Americans

who suffer from the effects of Migraines. In addition

to the new

indication to treat Migraine Pain, Vioxx® is approved for the

management of Acute

Pain based on studies that have shown Vioxx®

provided effective

Analgesic relief for moderate to severe Dental Pain,

Primary Dysmenorrhea

and post-Orthopedic Surgical Pain. Vioxx® also is

approved for the

treatment of the Chronic Conditions of OsteoArthritis

and Rheumatoid

Arthritis in adults. The new indication for Vioxx® for

Migraine was based

on two Double-Blind, Placebo-Controlled Multicenter

Studies that

enrolled approximately 1,600 patients who were treated for

a single Migraine

attack that included Headache Pain of moderate to

severe intensity.

Results from the

studies demonstrated that a single dose of Vioxx® 25

mg or 50 mg provided

significant Migraine Headache Pain relief compared

to placebo.1 Both

doses of Vioxx® also reduced the incidence of

Migraine Symptoms

including Sensitivity to Light (Photophobia), Sound

(Phonophobia) and

Nausea.

Findings from the

two pivotal single-dose studies among patients taking

Vioxx® 25 mg

(n=363), Vioxx® 50 mg (n=375) or placebo (n=362) revealed:

· Vioxx® relieved

Migraine Pain at two hours: The percentage of

patients reporting

Headache relief at two hours following initial

dose in one study

was 54 percent with Vioxx® 25 mg and 57 percent

with Vioxx® 50 mg

compared to 34 percent with placebo; and in the

second study, the

percentage was 60 percent for Vioxx® 25 mg, 62

percent for Vioxx®

50 mg and 30 percent for placebo (p<0.001 vs.

placebo for both

studies).

· Vioxx® relieved

Nausea and sensitivity to Light and Sound: The

cumulative incidence

of Photophobia, Phonophobia and Nausea in one

study was reduced by

31 percent, 36 percent and 19 percent in patients

taking Vioxx® 25 mg,

Vioxx® 50 mg and placebo, respectively; and in

the second study, 39

percent of patients taking Vioxx® 25 mg and 44

percent taking

Vioxx® 50 mg experienced a reduction in the incidence

of Migraine Symptoms

compared with 23 percent taking placebo (p<0.001

vs. placebo for both

studies).

· Vioxx® decreased

use of rescue medications: Vioxx® significantly

reduced the number

of patients who took additional medication for

their migraine over

the 24 hours after taking Vioxx® compared to

placebo. In studies,

Vioxx® was effective regardless of gender, race,

age or the presence

of aura, menses or Dysmenorrhea. Vioxx® was also

effective regardless

of whether or not there was a history of prior

response to

non-Steroidal anti-Inflammatory Drugs (NSAIDs). Use of

Vioxx® in

conjunction with common Migraine preventative medications,

such as

Beta-blockers, Calcium Channel Blockers, Tricyclic

anti-Depressants; or

Oral Contraceptives did not affect efficacy.

The most common

adverse events occurring in patients taking Vioxx®

compared to placebo

in the single-dose studies were Dizziness, Nausea,

Somnolence and

Dyspepsia. In a three-month extension of one Migraine

Study, the most

common adverse events among patients taking Vioxx®

were Dizziness, Dry

Mouth, Nausea and Vomiting.

For the acute

treatment of Migraine attacks, the recommended starting

dose for Vioxx® is

25 mg once daily. Some patients may receive

additional benefit

with 50 mg as compared to 25 mg. The maximum

recommended daily

dose is 50 mg. The safety of treating more than

five Migraine

attacks in any given month has not been established.

Chronic daily use of

Vioxx® for the acute treatment of Migraine is

not recommended. The

safety and effectiveness of Vioxx® have not

been established for

Cluster Headache, which is present in an older,

predominantly Male,

population.

Important

information about Vioxx®

People with Allergic

Reactions, such as Asthma, to Aspirin or other

Arthritis medicines

should not take Vioxx®. In rare cases, serious

stomach problems,

such as Bleeding, can occur without warning. Patients

should inform their

Physicians if they have Liver or Kidney Disease, or

a history of Angina

(chest pain), Heart Attack or a Blocked Artery in

their Heart. Vioxx®

cannot take the place of Aspirin for the prevention

of Heart Attack or

Stroke. Vioxx® should not be used by women in late

pregnancy.

Commonly reported

side effects in clinical trials with Vioxx® have

included

upper-Respiratory Infections, Diarrhea, Nausea and High Blood

Pressure. Vioxx® is

approved in the United States for the relief of

the signs and

symptoms of OsteoArthritis, adult Rheumatoid Arthritis,

management of Acute

Pain in adults and Primary Dysmenorrhea. The

recommended starting

dose of Vioxx® for the treatment of OsteoArthritis

is 12.5 mg once

daily. Some patients may receive additional benefit by

increasing the dose

to 25 mg once daily. For Rheumatoid Arthritis, the

recommended dose is

25 mg once daily. The maximum recommended daily dose

for OsteoArthritis

and Rheumatoid Arthritis is 25 mg once daily. Vioxx®

50 mg once daily is

the recommended dose for acute pain and Primary

Dysmenorrhea. Use of

Vioxx® for more than five days in management of

pain has not been

studied. Chronic use of Vioxx® 50 mg is not recommended.

Migraine is not just

a Headache

Migraine is a

Disease that impacts approximately 28 million Americans2,

the majority of them

women. Unlike a bad Headache, Migraines are

characterized by

attacks of intense, usually one-sided, throbbing Head

Pain which can last

anywhere from four to 72 hours. The pain associated

with Migraine is

frequently accompanied by other unpleasant symptoms,

including Nausea,

Vomiting and increased sensitivity to Light and/or Sound.

In a recent

household survey of more than 23,500 men and women who

reported they

suffered from Migraines3, nine out of 10 (92 percent)

described their

Migraines as moderate or severe, with nearly a half

(47 percent)

reporting they have experienced Migraines for more than

10 years. Among

women surveyed, more than half (52 percent) said

they experienced

Migraines anywhere from once a month to more than

three per month. The

survey also revealed how under-diagnosed

Migraines are with

nearly a quarter (23 percent) noting the last time

they discussed

Migraines with their Physician was two years ago or

longer and that

approximately one-third (34 percent) have never taken

a medication for

Migraine relief.

References

1 Defined as change

in intensity from moderate or severe pain at

baseline to mild or

no pain after dosing. 2 Lipton RB, Diamond S,

M, Diamond ML,

WF. Migraine diagnosis and treatment: results

from the American

Migraine Study II. Headache. 2001;41:638-645. 3 2003

Merck Market Research Health Conditions Study

(NFO).

Vioxx® is a

registered trademark of Merck & Co., Inc.

SOURCE: Merck &

Co., Inc

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256E690066E2CD

Your shorter link

is: http://makeashorterlink.com/?R2A752FF7

Hugs,

Deanna