CRED NPM

05/11/2024

Why Naratriptan in OTC?

• Migraine is a chronic disease impacting 4.5% of adults in Germany

• Duration of untreated attack 4 – 72 hours

• Symptoms are severe and require immedate treatment (strong headache, but also accompanied by symptoms as nausea, dizziness and sentitivity to light or noise) • Compared to other analgesics or NSAIDs available as OTC, Triptans as Naratriptan provide a very selective acute treatment of migraine (binds to serotonin receptors leading to vasoconstriction of widened blood vessels in the brain)

Naratriptan

Widened blood vessel in the brain during migraine attack

Symptom relief by vasoconstriction of blood vessels

Early treatment beneficial

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The Organisation for Professionals in Regulatory Affairs

Source: internal training material GSK Consumer Healthcare

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Naratriptan switch- major milestone the history of Rx to OTC switches

• 1997 introduction of Naratriptan as 2 nd generation triptan with Rx status • Approval of switch in Germany 2006: first triptan with OTC status worldwide • Reclassification allows immediate treatment in case of an attack („ attack pack“) without the need to consult a doctor → public health benefit

The Organisation for Professionals in Regulatory Affairs

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