FDA approves Vioxx for acute treatment of migraine in adults
FDA approves Vioxx for acute treatment of migraine in adults
WHITEHOUSE STATION, N.J., April 1, 2004 -- Vioxx (rofecoxib), Merck's once-daily arthritis and pain medicine, has received approval from the 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 symptom
"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 Stephen 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."
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 nonsteroidal anti-inflammatory drugs (NSAIDs). Use of Vioxx in conjunction with common migraine preventative medications, such as beta-blockers, calcium channel blockers, tricyclic antidepressants; 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.
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, Reed M, Diamond ML, Stewart 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).
Source: Merck
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