US regulators have green-lighted the use of Impax’ Zomig to treat migraine in patients aged 12 years and older, marking approval of the first nasally-delivered prescription medicine for this age group.
The US Food Administration’s nod is for the treatment of acute migraine with or without aura, offering an alternative method of delivery that is particularly useful for those who experience related nausea or are unable to take an oral formulation.
Zomig (zolmitriptan) Nasal Spray was first approved in the US for adults with acute migraine in September 2003. Paediatric clearance is based on clinical data showing that the spray is significantly more effective in addressing symptoms of migraine than a placebo, with a similar safety profile to that seen in adults, the firm said.
The one-year prevalence of migraine among US children aged 12 to 19 is estimated by the American Migraine Prevalence and Prevention Study to be around 6.3%, and treatment options for this age group remain limited.