A new once-daily medication to treat patients with attention deficit and hyperactivity disorder (ADHD) aged 13 and above has been approved by the US Food and Drug Administration (FDA). Shire first filed an application to market the drug in US pharmacies in 2006, but was required to conduct further studies to gain approval from the regulatory body.
Mydayis, formerly known as SHP465, contains the same active ingredients as the commonly prescribed Adderall XR, also produced by Shire. However, the new formulation has a slower release, utilizing three types of drug-releasing beads to help patients manage symptoms for up to 16 hours; four hours more than Adderall XR. The new amphetamine from Shire is designed to simplify dosages for patients who currently take two doses per day.
ADHD is a neurodevelopment disorder often diagnosed in childhood. An estimated five percent of children have ADHD, according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders. However, studies by researchers at the Centers for Disease Control and Prevention suggest this proportion could be even higher, with one survey of parents in 2011 suggesting more than one in ten children between four and 17 are diagnosed with the condition.
Key Stats on ADHD:
11% of school children diagnosed with ADHD by 2011. 1
6.1% of school children were taking medication for ADHD in 2011. 1
4.4% of adults in the U.S. have ADHD, equating to more than 10 million people across the country. 2
A total of 16 clinical studies evaluating the efficacy and safety of Mydayis were conducted on more than 1,600 subjects with ADHD. In placebo controlled studies, the drug was found to significantly improve the symptoms of ADHD. Improvements were measured using the ADHD-RS-IV and Permanent Product Measure of Performance.
Andrew J. Cutler, MD, an investigator in the Mydayis clinical trials, and executive vice president and chief medical officer at Meridien Research, commented: "Many of my patients living with ADHD are trying to manage symptoms that impact them in different settings - often across home life, school or work, and in social settings. Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options."
A variety of medications are prescribed to treat patients with ADHD, including Ritalin (methylphenidate) and Focalin (dexmethylphenidate). Among the medications indicated for use in patients under the age of 13 are Adderall, Concerta (methylphenidate long-acting), Desoxyn (methamphetamine hydrochloride) and Dexedrine (dextroamphetamine).
Mydayis is expected to be on pharmacy shelves and available to adults and adolescents aged 13 and over in the third quarter of 2017.
For more information on Mydayis, visit the link below:
1 Visser, S. N., Danielson, M. L., Bitsko, R. H., Holbrook, J. R., Kogan, M. D., Ghandour, R. M., . . . Blumberg, S. J. (2014). Trends in the Parent-Report of Health Care Provider-Diagnosed and Medicated Attention-Deficit/Hyperactivity Disorder: United States, 2003–2011. Journal of the American Academy of Child & Adolescent Psychiatry, 53(1). doi:10.1016/j.jaac.2013.09.001
2 R. Kessler, The Prevalence and Correlates of Adult ADHD in the United States: Results From the National Comorbidity Survey Replication, American Journal of Psychiatry. 163 (2006) 716. doi:10.1176/appi.ajp.163.4.716.