|†||Headache response was defined as an improvement from moderate to severe headache to mild or no pain after dosing; sustained headache response was defined as headache response by 2 hours with no recurrence and no use of rescue medications within 24 hours.|
|‡||Pain free response was defined as going from severe or moderate pain to no pain after dosing; sustained pain-free response was defined as achieving a pain-free response by 2 hours, with no recurrence and no use of rescue medication within 24 hours.|
|§||Odds ratio, 1.64; P<.05. Odds ratios for clinical response with RELPAX 40 mg vs Imitrex 100 mg were determined by logistic regression calculation of data from a meta-analysis of 3 head-to-head studies. An odds ratio of 1.64 indicates that a patient taking RELPAX 40 mg was 64% more likely to have a sustained pain-free response at 24 hours than if the patient had been treated with Imitrex 100 mg.|
Why pain-free response matters
Updated International Headache Society Guidelines state that the pain-free response end point is simple, clinically relevant, and reflects the patient's treatment expectations.8
Please scroll for Important Safety Information and Indication
Important Safety Information
RELPAX is contraindicated for patients with:
RELPAX may cause the following:
- Myocardial ischemia/infarction, Prinzmetal’s angina. These events may occur even in patients without known disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, administer first dose of RELPAX in a medically supervised setting.
- Arrhythmias: discontinue RELPAX if these disturbances occur.
- Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness commonly occur after treatment with RELPAX and are usually non-cardiac in origin. Perform a cardiac evaluation if these patients are at cardiac risk.
- Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as gastrointestinal vascular ischemia and Raynaud’s syndrome; and increases in blood pressure have been reported with RELPAX. Discontinue the use of RELPAX if any of these events occur.
- Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.
- Serotonin syndrome may occur with RELPAX particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). Discontinue RELPAX if serotonin syndrome is suspected.
In clinical trials, the most common adverse events reported with treatment with RELPAX 40 mg compared with placebo were dizziness (6% vs 3%), somnolence (6% vs 4%), asthenia (5% vs 3%), and nausea (5% vs 5%).
RELPAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
RELPAX is a serotonin (5-HT 1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura. RELPAX should be used only after a clear diagnosis of migraine has been established. It is not recommended for the prophylactic treatment of migraine or for the treatment of cluster headache.