The FDA has recently approved Cotempla XR-ODT
(methylphenidate orally disintegrating tablet, extended release) for ADHD in
children ages 6-17.
This drug, produced by Neos Pharmaceuticals, is a stimulant.
The active ingredient, methylphenidate, has been on the market for a long
time as a medication for ADHD. The main difference is the
formulation. Similar to Concerta, Quillivant XR, and Aptensio XR, it is long
acting, however it is an orally disintegrating tablet, meaning that it can be
taken without the need to swallow a pill or manage a liquid.
Disadvantages
Cost. Like Quillivant and Aptensio XR,
Cotempla 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 is anticipated to be fall of 2017. 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 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. This is standard
for new stimulant medications for ADHD because very little is known about ADHD
and its treatment in younger children.
Not as easy to titrate as a liquid. The orally dissolving technology
does not allow the dose of this medicine to be easily divided. The tablet should not be crushed or broken
before being taken. Unlike Adzenys (another orally dissolving tablet for ADHD), Cotempla XR-ODT only comes in 3 sizes of tablets, which may limit the ease of adjusting the dose.
Purple coloring.
The medication contains grape flavoring and a purple colorant called
Lake Blend Purple. The colorant is a mix
of FDA approved colorants but the specific component colorants not
specified. Those patients who are
sensitive to blue, red, or other colored dyes should be aware that the colorant
may potentially worsen symptoms. This
was not noted in clinical studies, however.
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 methylphenidate (Ritalin), this pill is designed in a way
to mask the bitter taste of the active drug.
Should you use Cotempla XR-ODT?
The ideal candidate for Cotempla XR-ODT falls into one of two
categories:
1) Unable to swallow pills. Depending on your insurance
coverage, Cotempla may be as expensive, or less expensive than Quillivant and
QuilliChew. Focalin XR, which can
be opened and sprinkled on food 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. Like
QuilliChew, which was approved in 2015, the orally dissolving tablet does not
require food, 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 methylphenidate. It is simply another
alternative.
Reference:
Marketing, Benchworks.
"Neos Therapeutics Announces FDA Approval of Cotempla XR-ODT™
(methylphenidate) Extended-Release Orally Disintegrating Tablets for the
Treatment of ADHD in Patients 6 to 17 Years Old." Neos Therapeutics, Inc. Neos Therapeutics, Inc., 19 June 2017.
Web. 24 June 2017.
No comments:
Post a Comment