The FDA
recently announced the approval of a new drug for ADHD, Adzenys XR ODT. This drug, produced by Neos
Pharmaceuticals, is a stimulant. The active ingredient, amphetamine, has
been on the market for a long time as a medication for ADHD, narcolepsy, and
obesity. The main difference is the formulation. Similar to
Dyanavel XR and Adderall XR, it is a long acting, however it is an orally
disintegrating tablet, meaning that it can be taken without the need to swallow
a pill.
Disadvantages
Cost. Like Dyanavel XR, Adzenys XR ODT is
likely to be pricey as the orally disintegrating tablet technology is still
under patent, and the company is also paying royalties to Shire, LLC. It will likely not be covered by insurance when it is first released, which the company projects will be around the second quarter of 2016. Neos Pharmaceuticals does not currently offer
any kind of discount or coupon program for this product, nor any other product.
Nothing new. This drug does not really offer
anything new in terms of avoiding potential risks. It has been designed
to be bioequivalent to Adderall XR. 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 (yet) for
children less than 6 years of age. The FDA
has asked the company to perform further studies on younger children prior to
approving this drug for use in children 4 and 5 years of age.
Not as easy to titrate as a liquid. The orally dissolving technology does not
allow the dose of this medicine to be easily divided.
Advantages
Does not need to be swallowed whole. This drug is likely to find a place with younger patients who
cannot swallow pills.
Different. As with other stimulants, this one has a unique release profile
which may suit some patients better than others.
Taste.
Compared to crushed amphetamine salts (Adderall), this pill is designed
in a way to mask the bitter taste of amphetamine.
Should you use Adzenys XR-ODT?
The ideal candidate for Adzenys XR-ODT falls into one of two
categories:
1) Unable to swallow pills. Depending on your insurance
coverage, Adzenys may be as expensive, or less expensive than Quillivant or
Dyanavel. Focalin XR, which can be opened and sprinkled may still be a
major competitor, as it is available as a generic. Focalin XR can probably be titrated more
easily because in a pinch, the capsule can be opened and the dose split. It is not clear that the ODT technology will
or will not allow Adzenys to be split but the pill is not scored. Adzenys, however, does not require the user
to sprinkle the pill’s contents on applesauce or other food or water, which is
slightly more convenient.
2) Intolerant of other stimulants.
This medication offers another option for patients who are not able to
take other stimulants due to side effects.
It is not, however, specially designed to prevent side effects and so is
not preferable over other forms of
amphetamine salts. It is simply another
alternative.
Reference:
"Neos Therapeutics Announces
FDA Approval of Adzenys XR-ODT™ (Amphetamine Extended-Release Orally
Disintegrating Tablet) for the Treatment of ADHD in Patients 6 Years and
Older." Neos Therapeutics. Neos Therapeutics, Inc., 27 Jan. 2016.
Web. 28 Jan. 2016.
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