The need for college students or adults with attention deficit hyperactivity disorder (ADHD) to take a mid-afternoon boost of amphetamine could go away with the arrival of Mydayis, a once-daily, mixed salts single-entity amphetamine that lasts up to 16 hours. It launched last month following its FDA approval
June 20, 2017.
Physicians and nurse practitioners gathered Saturday at the 30th US Psychiatric and Mental Health Congress in New Orleans, Louisiana, to hear a panel discussion about Mydayis, led by ABC News Chief Women’s Health News Correspondent Jennifer Ashton, MD. Shire PLC, well-known for Adderall XR, sponsored the event.
Ashton shared the data on ADHD: the condition affects 1 in every 23 people or 10.5 million adults, one of them being Ashton’s 19-year-old son. The condition affects more men than women. Greater awareness of what ADHD looks like hasn’t always translated into more treatment options, however.
Mydayis, which has the same active ingredient as Adderall XR, took more than 10 years and 16 studies before FDA gave its approval. Clinical studies eventually involved more than 1600 patients and were summarized at Saturday’s presentation. Mydayis improved symptoms of ADHD as measured on the ADHD-RS-IV and the Permanent Product Measure of Performance, a skills-adjusted math test.
As a graphic displayed during the presentation showed, the drill for many with ADHD can be complicated: first comes the extended release (XR) amphetamine with breakfast, which starts working after about 30 minutes and peaks after about 4 hours, then tapers off all afternoon; next comes the spike of the midafternoon dose of immediate-release (IR) amphetamine, which carries the person with ADHD through the evening.
But does it? Both audience members and the panel experts felt that care for adult ADHD patients centers on getting them through the work day, not social settings. Charles P. Vega, MD, a clinical professor of Family Medicine at the University of California Irvine, said that’s not so unusual.
“Symptoms at work tend to dominate the conversation among adult patients with ADHD; this is a holdover phenomenon from when they might have been experiencing symptoms at school,” Vega said.
“As a clinician, you want to address the most pressing needs of the patient, and so that means addressing the symptoms during the work day is important,” he continued. “But patients may lack the insight as to how their ADHD affects the other parts of their day.”
Both Vega and Alice Mao, MD, a board-certified psychiatrist at Baylor University, agreed that it’s important to constantly assess and reassess how patients’ responses are affecting their day, perhaps by speaking with a partner or family member.
Patients with ADHD can use both pharmacologic and nonpharmacologic strategies like coaching, Vega said. But what’s clear from review of real-world data, he said, is that among patients using long-acting stimulants, 20% used more than 1 medication per day.
As Rakesh Jain, MD, MPH, assistant professor of psychiatry at the University of Texas explained, “the real experts,” the patients, don’t find this acceptable, and 81% report they have erratic days. “Some days are much worse than others; 44% of the patients said the afternoon was the most challenging time of the day.”
These needs demand a response, Jain said. “We cannot make ADHD their problem. It’s our problem.”
For the right patients, Mydayis offers the opportunity to get rid of that afternoon dip and spike—not to mention the problems that arise if patients forget to bring the IR medication to their afternoon class or job. A poll of audience members found 92% liked the idea of being able to give their patients a single pill in the morning, compared with multiple pills throughout the day. Even if a different stimulant worked for a patient in the past, something new may be needed; for example, if the person has new responsibilities.
“ADHD is a condition that is dynamic,” Jain said. “Needs change. Responses change.”
Mydayis is approved for adolescents and adults age 13 and older only. Because it is an amphetamine, it has a black box warning for a high chance of abuse and dependence. Side effects include insomnia, decreased appetite, dry mouth, increased heart rate, anxiety, irritability, nausea, and weight loss.
The 3-bead technology.
Kelly C. Lee, PharmD, MAS, BCPP, professor of clinical pharmacy at University of California San Diego, explained the distinguishing feature of Mydayis: the 3-bead technology, which allows the active ingredient to be released at different times over the 16-hour period at different pH levels. The first bead releases in the stomach, and the second 2 release at different locations in the small intestine. The beads have different coatings to ensure different release points.
The graphic of the pharmacokinetics of Mydayis shows the result: a continuous 16-hour curve, with no interruptions or mid-afternoon spikes.
It’s important, said Catherine Poulos, MPHNP-BC, a psychiatric nurse practitioner, that patients taking Mydayis develop a routine. It can be taken with or without food, but it should be taken the same way each day. She tells patients to set a glass of water by the bedside as a reminder. If a dose is missed, it shouldn’t be taken late in the day. Lee said it’s not appropriate for patients with a history of seizures and must be stopped if one occurs.
Mydayis patients start at doses of 12.5 mg, with other doses available at 25 mg, 37.5 mg, 50 mg, but results were seen at lower doses (the higher doses are recommended only for adults, not those ages 13-17).
Poulos emphasized the need for constantly gauging patient needs. “I’m all about the reassessment—getting the right dose to the right patient.”
Jain, meanwhile, closed with observation that the physicians in the room had overwhelming supported the idea of a single dose of amphetamine a day. “To me, that is the key.”