The Food and Drug Administration has approved Shire PLC (ADR) (NASDAQ:SHPG) once daily treatment for attention deficit hyperactivity disorder (ADHD), Mydayis. The approval is a milestone achievement as the drug will complement the company’s other treatments for the cognitive condition.
Mydayis contains the same ingredient as Adderall XR, another treatment for ADHD formulated to last 12 hours. However, it is formulated to last up to 16 hours something that Shire believes will give it an edge against other generic forms currently in use. Approval of Mydayis is based on 16 clinical studies that Shire says it carried on 1,600 subjects targeting adolescents between the age of 13 and 17 as well as adults.
Results show that the drug considerably improved symptoms of ADHD as measured by Product Measure of Performance in adults and adolescents. Mydayis contains amphetamine, a stimulant used to elevate levels dopamine.
“Mydayis is the latest innovation in Shire’s 20-year legacy of helping to support the treatment of ADHD. It’s a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD,” said CEO Fleming Ornskov.
The drug is designed to eliminate the use of short-acting stimulants. Misuse of the drug according to a safety notice on the drug can cause physical and psychological dependence. The drug is also not for use in children below the age of 12.
Mydayis should help bolster Shire revenues on the sale of drugs for cognitive conditions. The company’s lead products in the space Adderall XR and Vynasse, generated close to $2.4 billion in sales last year. Shire plans to make the treatment available for sales in the U.S in the third quarter. The company is yet to disclose how much it will charge for the treatment
Attention deficit hyperactivity disorder (ADHD) is a cognitive condition that affects millions of children all over the world, affecting their development. Currently, there is no cure for the condition. However, there are accepted treatments that people can use to control the condition’s symptoms.
Shire stock was up by 1.34% in Tuesday’s trading session to end the day at $167.26 a share.