Treating a migraine in progress has been more difficult for children and adolescents because their available choices for acute migraine treatment have been even more limited than the choices available for adults. There are fewer treatments approved by the FDA for children and adolescents than for adults. This has been, at least in part, due to the logical and reasonable reluctance to perform clinical trials of new medications with children and adolescents. Researchers have long been reluctant to do trials with them because of not wanting to take any risks with them.
After many years of migraine abortive medications being used safely by adults, we're finally seeing them approved for children and adolescents. Last month, I reported that Treximet had received FDA approval for use by adolescents 12- to 17-years-old. Since then, Zomig Nasal Spray has been approved by the FDA for use by the same age group.
At that time, Dr. David Watson, director of the headache center at West Virginia University, offered a comment that is just as applicable to this news:
"This is good news for adolescents and their parents. As we all know, each acute medication doesn't work for everybody. So the more options available the better."
Zomig Nasal Spray is the first nasal-delivered prescription medication approved for the acute treatment of migraine attacks in pediatric patients. Nasal sprays may offer an alternative method of administration when patients experience migraine-associated nausea, have difficulty taking oral formulations, or do not have liquids available. Zomig Nasal Spray's approval came after the FDA's review of safety and efficacy data from pivotal clinical trials demonstrating that Zomig Nasal Spray 5 mg is significantly more effective than placebo in providing relief of headache, and other associated symptoms of migraine when treating migraine in pediatric patients. In clinical trials, the medication also had a safety profile similar to that demonstrated in adults.
The American Migraine Prevalence and Prevention (AMPP) Study estimated the one-year prevalence of migraine among American children ages 12 to 19 at 6.3%, with prevalence among boys at 5.0% and among girls 7.7%. Dr. Alan M. Rapoport, Past President of the International Headache Society and Clinical Professor of Neurology at the David Geffen School of Medicine, said:
"Until now, there have been few medications to treat pediatric patients with painful, debilitating attacks of migraine."
Fred Wilkinson, President and Chief Executive Officer of Impax Laboratories, commented:
"We are pleased that Zomig Nasal Spray has been approved by the FDA for use in patients ages 12 to 17. Treatment options have been limited for pediatric patients and we are pleased with FDA's decision and look forward to bringing migraine relief to pediatric patients by making Zomig Nasal Spray available to this 'school age' patient population. This expanded indication exemplifies our strategy to broaden the reach of our current product portfolio to address unmet needs in underserved therapeutic areas, thereby adding value for patients and shareholders alike."
This approval of Zomig Nasal Spray brings the number of triptan medications approved for children and / or adolescents to four:
- Zomig Nasal Spray, approved for use by adolescents 12- to 17-years-old in June, 2015.
- Treximet was approved for use by adolescents 12- to 17-years-old in May, 2015.
- In December of 2011, the FDA approved the triptan Maxalt (rizatriptan) for use in children and adolescents ages six- to 17-years-old.
- Axert (almotriptan) was approved for adolescents ages 12- to 17-years old in June of 2009.
More Helpful Information:
Press Release. "FDA Approves ZOMIG® (zolmitriptan) Nasal Spray for Migraine in Pediatric Patients (Ages 12-17)." HAYWARD, Calif., June 16, 2015 /PRNewswire/ -- Impax Specialty Pharma, adivision of Impax Laboratories, Inc.
_a Headache and Migraine Organization _
_for Patient Empowerment _
_Visit the AHMA Web Site _