Adolescent Migraine - Zomig Nasal Spray Demonstrates Relief in a Clinical Trial

Main Category: Headache / Migraine
Article Date: 23 Jun 2005 - 14:00 PST

email to a friend   printer friendly   opinions  

New clinical trial data presented today at the 47th American Headache Society (AHS) Annual Scientific meeting showed that AstraZeneca's ZOMIG (zolmitriptan) Nasal Spray 5 mg achieved a 58.1 percent headache response rate in adolescents compared to 43.3 percent with placebo after one hour (p<0.02) - a 14.8 percent difference.

http://http://www.zomig.com

"For so long, migraine treatment research in adolescents has been limited," said Dr. Paul Winner, codirector of the Palm Beach Headache Center. "This study is an important step in understanding adolescent response to migraine treatment."

The ZOMIG Pediatric Nasal Spray Study was a two-attack, randomized, multicenter, double-blind, placebo-controlled, two-way, crossover study with a single blind placebo challenge designed to evaluate the efficacy of ZOMIG Nasal Spray in 248 adolescents with migraine. Each initial migraine attack was treated with placebo nasal spray. If headache pain remained moderate or severe after fifteen minutes, patients were then treated with ZOMIG Nasal Spray or placebo nasal spray. In addition, a worst-case scenario analysis was performed. Due to the unique study design, ZOMIG Nasal Spray was not statistically significant compared to placebo. ZOMIG Nasal Spray was well tolerated.

Additional data from the trial demonstrated

-- A 37.2 percent headache response after 15 minutes for ZOMIG Nasal Spray compared with 22.8 percent with placebo (p<0.02)

-- ZOMIG Nasal Spray had a one hour pain-free rate of 27.7 percent compared with 10.2 percent with placebo (p<0.001)

Adolescents and Migraines

Migraine is a type of headache that usually happens in episodes or "attacks." Attacks may last anywhere from 4 hours to as long as 72 hours.1 Long considered just another type of headache, migraine is now recognized as a distinct neurological process.2 The pain of a migraine headache is generally moderate to severe and can disrupt normal activities. Migraine is common among adolescents, and it is estimated that up to 10 percent of adolescents in the U.S. are affected by migraine and that up to 2.75 million school days are missed annually because of migraine attacks in children and adolescents.3 In fact, 20 percent of adults report onset of headaches prior to age ten.4 Five percent of all children and adolescents by the age of 15 have had migraines.5

About ZOMIG

The ZOMIG brand family is currently marketed in three dosage forms: ZOMIG (zolmitriptan) Tablets (5.0 mg and 2.5 mg), ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets (5.0 mg and 2.5 mg), and ZOMIG (zolmitriptan) Nasal Spray. All three of the ZOMIG dosage forms are indicated for the acute treatment of migraine with or without aura in adults. ZOMIG is not intended for the prophylactic therapy of migraine or for the use of the management of hemiplegic or basilar migraine. ZOMIG should be not be taken by patients who have certain types of heart disease or uncontrolled high blood pressure. Very rarely, some people without recognized heart disease may have serious heart-related problems. The most common side effects associated with taking oral ZOMIG include dizziness; tightness, pressure or pain in the neck, throat, or jaw; fatigue; tingling sensations; drowsiness; and nausea.

ZOMIG and ZOMIG-ZMT are registered trademarks of the AstraZeneca group of companies.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com

References
1 - ZOMIG web site: http://http://www.zomig.com. Accessed on 6/16/05.
2 - Migraine Headache Misconceptions: Barriers to Effective Care. Pharmacotherapy, 24(5):638-648, 2004.
3 - Hartmaier SL, et al. Development of a brief 24-hour adolescent migraine functioning questionnaire. Headache 2001; 41: 150-156.
http://headaches.about.com/cs/druginfo/a/imitrex_ns10.htm. Accessed on 6/16/05.
4 - American Council for Headache Education, http://www.achenet.org/kids. Accessed on 6/16/05.
5 - The Cleveland Clinic, http://my.webmd.com/content/article/46/1826_50690.htm. Accessed on 6/16/05.

• Additional
• References
• Citations