The FDA has recently approved Mydayis (mixed salts of a single entity amphetamine product) for treatment of ADHD in children and adults 13 years of age and older.
This drug, produced by Shire, is a stimulant. The active ingredient, amphetamine salts, has been on the market for a long time as a medication for ADHD. The main difference is the formulation. It's closest relative is Adderall XR, but unlike Adderall XR, it is the first in it's class of ultra-long acting stimulants, which can be taken at night and be active from 2-4 hours after the patient takes it until 16 hours later, thereby allowing the medication to be active from the first moment the patient wakes up.
Disadvantages
Cost. Like any new medication Mydayis is likely to be expensive while it is under patent. However, Shire provides assistance to needy patients who require this medication through its patient assistance program, Shire Cares. Also, the first 3 months are covered by a coupon/voucher program.
Nothing new. This drug does not really offer anything new in terms of avoiding potential risks. It is still causes issues with appetite, sleep, anxiety, emotionality, and other symptoms commonly associated with stimulants in some patients.
Drug levels likely to take a long time to stabilize. Clinical studies have not actually addressed this issue, but we often see that long acting drugs often manifest side effects later in the game--6 to 8 weeks later. We would not expect things to be different with this drug.
Not approved for children less than 13 years of age. Children younger than 13 were noted to have much higher rates of insomnia (30%) and appetite suppression (43% vs. 22%), as well as having higher drug levels after a single dose. For this reason it is unlikely to be approved for younger children.
Difficult to deal with missing doses. If you miss a dose, you'll definitely have to wait until the next day. It would be possible to take a short acting medication to cover the gap, but obviously your morning would still suffer.
Difficult to deal with missing doses. If you miss a dose, you'll definitely have to wait until the next day. It would be possible to take a short acting medication to cover the gap, but obviously your morning would still suffer.
Advantages
Works in the morning. The main advantage of Mydayis is that it allows patients to have the benefit of their stimulant from the time when they wake up, onward through the day. No waiting for your med to kick in before you can really function. No more difficult mornings.
Different. As with any new formulation, a different time release can produce advantages for some patients. The let down off of Mydayis, for example, may not be as dramatic as with Adderall XR because it acts for so long. The timing of Mydayis may also be helpful to some adults who have different workschedules.
Different. As with any new formulation, a different time release can produce advantages for some patients. The let down off of Mydayis, for example, may not be as dramatic as with Adderall XR because it acts for so long. The timing of Mydayis may also be helpful to some adults who have different workschedules.
Should you use Mydayis?
If you are an adult or teen and have symptoms in the morning which make it difficult to function, Mydayis may be an option for you, especially if Adderall is a medication which works well for you once it is on board.
References:
Mydayis [package insert]. Shire, LLC., Lexington, MA; June 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf. Accessed November 19, 2017.
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