The sumatriptan / naproxen fixed combination
Prescribing information and Adverse event reporting can be found at the bottom of the page.
SUVEXXTM is a combination of two commonly used acute migraine medications in a single tablet: sumatriptan 85 mg and naproxen sodium 500 mg. Combining medications with different mechanism of action, a triptan and a nonsteroidal anti-inflammatory drug appears to be more effective than using either drug alone.
SUVEXXTM is indicated for the acute treatment of the headache phase of migraine attacks with or without aura in adults where treatment with a mono-entity product has been insufficient.
Studies evaluating the combination of sumatriptan plus naproxen found that more people with moderate or severe attacks reported significant headache relief or were pain-free after 2 hours with the combination of sumatriptan and naproxen, compared to sumatriptan alone, naproxen alone, or with placebo.1
Most patients on combination treatment who were pain-free at 2 hours, remained pain free at 24 hours without a need of any additional rescue medication.1 The presence of both the rapid acting sumatriptan and the long-acting naproxen in the combination is at the origin of its rapid and sustained effect.2
Two replicate, randomized, controlled studies were conducted, in which the treatment was taken while pain intensity was moderate to severe. The study results shown here are for Study 1.
Two replicate, randomized, controlled studies were conducted The study results shown here are for Study 1.
The formulation of SUVEXXTM contributes to the rapid disintegration of the tablet and release of sumatriptan in the gastrointestinal tract.2 When SUVEXX TM is administered in healthy volunteers, the Tmax(median) of sumatriptan succinate is 30 min earlier than the Tmax observed when a single dose of sumatriptan succinate 100mg (rapid release technology, RT™) is administered alone.6 Conversely, the Tmax(median) of naproxen after administration of SUVEXX TM comes later, at 6 hours, which is about 3–5.5 hrs later when compared to single dose of naproxen sodium 500 mg administered alone.7,8 In another study, when SUVEXX TM is administered during a migraine attack, the Tmax(median) of sumatriptan succinate is 1.5 hrs (range 0.5-4 hrs).8,9
SUVEXXTM SUPERIOR EFFICACY: Pain relief response at 2 hours is improved with sumatriptan-naproxen 85mg/500mg combination when compared to sumatriptan 85mg and placebo.1
SUVEXXTM SUSTAINED RESPONSE: Most patients who were pain-free at 2 hours after treatment with sumatriptan-naproxen combination, remained pain-free for 24 hours with no additional rescue medication.1
IN THE SUVEXXTM COMBINATION, the pharmacokinetic profile of sumatriptan and naproxen addresses both early and late phases of migraine attacks with the rapid tmax of sumatriptan in synergy with the delay in the tmax of naproxen.2
SUVEXXTM CONSISTENT RESPONSE UP TO 1 YEAR: Pain relief at 2 hours was reported for 81 % of attacks treated with sumatriptan-naproxen with no attenuation of therapeutic effect over time up to 12 months.3
SUVEXXTM QoL BENEFITS: Sumatriptan-naproxen combination provides consistent relief of migraine attacks, resulting in improved patient satisfaction and migraine specific quality of life.3,4
The recommended dose is 1 tablet of SUVEXXTM taken at the start of migraine pain. The maximum dosage is 2 tablets per 24 hours, taken at least 2 hours apart. This medication may be taken with or without food, but should not be split, crushed, or chewed.
References:
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Orion Pharma (UK) ltd on 01635 520300.