The Food and Drug Administration granted marketing approval Thursday to Shire for Intuniv, a nonstimulant treatment for attention-deficit hyperactivity disorder in children and adolescents aged 6 to 17.
Intuniv, an extended release tablet, is a once-daily formulation of guanfacine. Researchers believe the drug works by engaging receptors in the prefrontal cortex ? an area of the brain that has been linked in preclinical research to ADHD.
In the United States, about 8 percent of all school-aged children, or about 4.4 million children aged 4 to 17, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention. The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18 to 44.
Shire (NASDAQ:SHPGY) already has three other ADHD treatments in the United States and two ADHD medicines outside the United States. Intuniv is the company?s first nonstimulant-based ADHD treatment, and will be allowed to be purchased in 90-day supplies. The FDA places strict regulations on stimulant-based treatments ? which fall under the category of scheduled or controlled drugs and have high abuse risks ? including limiting prescriptions to 30 days.
Shire, based in Basingstoke, England, has its U.S. headquarters in Wayne, Pa.
Intuniv, an extended release tablet, is a once-daily formulation of guanfacine. Researchers believe the drug works by engaging receptors in the prefrontal cortex ? an area of the brain that has been linked in preclinical research to ADHD.
In the United States, about 8 percent of all school-aged children, or about 4.4 million children aged 4 to 17, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention. The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18 to 44.
Shire (NASDAQ:SHPGY) already has three other ADHD treatments in the United States and two ADHD medicines outside the United States. Intuniv is the company?s first nonstimulant-based ADHD treatment, and will be allowed to be purchased in 90-day supplies. The FDA places strict regulations on stimulant-based treatments ? which fall under the category of scheduled or controlled drugs and have high abuse risks ? including limiting prescriptions to 30 days.
Shire, based in Basingstoke, England, has its U.S. headquarters in Wayne, Pa.