The U.S Food and Drugs Administration approved Janssen Pharmaceuticals' Topamax for migraine prevention among individuals aged between 12 and 17 years.
This is the first approved migraine prevention treatment for adolescents. FDA said in a press statement that the drug can be taken on a daily basis to reduce the frequency of migraine headaches. The drug was first approved by the FDA in 1996 to prevent seizures and was extended for migraine prevention in adults in 2004.
"Migraine headaches can impact school performance, social interactions, and family life," said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research in a statement. "Adding dosing and safety information for the adolescent age group to the drug's prescribing information will help to inform health care professionals and patients in making treatment choices."
Statistics show that more than 37 million Americans suffer from migraines. Some migraine studies estimate that 13 percent of adults in the U.S. population have migraines, and 2-3 million migraine sufferers are chronic. Almost 5 million in the U.S. experience at least one migraine attack per month, while more than 11 million people blame migraines for causing moderate to severe disability.
The safety and effectiveness of the drug was tested in a clinical trial that enrolled 103 participants aged between 12 and 17. Researchers noted that the participants treated with Topamax experienced a 72 percent decrease in migraine frequency compared to a 44 percent decrease among participants given a placebo.
There were some side effects reported during the trails. These included a burning sensation in the hands, arms, legs, or feet; upper respiratory infection, abdominal pain and loss of appetite.
FDA officials warn that the drug may increase the risk of suicidal thoughts and behavior. If there are any signs and symptoms of depression, or unusual changes in mood or behavior, patients should seek immediate medical attention. The drug also increases the risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women who take the drug during pregnancy.
The FDA also noted that the drug should be sold with a Medication Guide that informs the user about its side effects and risks.
Recently, the administrating body also approved the marketing of the first medical migraine prevention device, "Cefaly," developed by STX-Med in Herstal from Belgium. While the device reduces the frequency of migraine attacks, it doesn't completely prevent migraines or reduce the intensity.
