NOMANESIT (sumatriptan/naproxene)

The Committee deems that the clinical benefit of NOMANESIT (sumatriptan 85 mg/naproxen sodium 500 mg) is substantial only for the acute treatment of the headache phase of migraine attacks with or without aura in adults where treatment with a triptan alone is insufficient and/or in the event of intense recurrences.

Considering:

• evidence of the superiority of a single dose of the NOMANESIT combination (sumatriptan 85 mg/naproxen sodium 500 mg) versus placebo and versus active substances as monotherapy in only one of the two studies in patients with a mean monthly frequency of 2 to 6 moderate to severe migraine attacks in the past three months (without specification of the mean number of monthly attacks),
• the percentage of patients having previously received treatment with oral sumatriptan (31%) during the studies concerned, without specification of failure or otherwise of this previous treatment,
• recommendations that have been in place for several years to combine a triptan and an NSAID as part of a strategy to optimise treatment of attacks when triptan is ineffective,
• the safety profile reported in the short term for this fixed-dose combination (maximum of 12 months), predominantly with a single dose (70% of patients versus 30% having received two consecutive doses) having been similar to the safety profile established for the respective active substances as monotherapy,

the Committee deems that NOMANESIT (sumatriptan 85 mg/naproxen sodium 500 mg) provides no clinical added value (CAV V) in the therapeutic strategy for acute treatment of the headache phase of migraine attacks with or without aura in adults where treatment with a triptan alone is insufficient and/or in the event of intense recurrences.