US regulators have approved the first treatment for the prevention of migraine headaches in adolescents aged 12 to 17 years, giving the nod to Janssen Pharmaceuticals’ Topamax (topiramate).
The green light was given on the back of a clinical trial involving 103 participants which showed that the drug slashed the frequency of migraine of around 72% compared to 44% in those taking a placebo.
On the safety side, the most common adverse reactions were found to be paresthesia (a burning or prickling sensation felt in the hands, arms, legs, or feet), upper respiratory infection, anorexia (loss of appetite), and abdominal pain, the regulator said.
Topamax was first approved by the US Food and Drug Administration in 1996 for the prevention of seizures, and later in 2004 for migraine prevention in adults.
