Neos Therapeutics, Inc. (Nasdaq:NEOS), a
pharmaceutical company focused on developing, manufacturing and
commercializing innovative extended-release (XR) products using its
proprietary modified-release drug delivery and orally
disintegrating tablet (ODT) technologies, today announced the
launch of Cotempla XR-ODTTM in select markets. The full nationwide
market launch of Cotempla XR-ODT will occur in early October. The
product was approved by the U.S. Food and Drug Administration (FDA)
on June 19, 2017 and is the first and only methylphenidate
extended-release orally disintegrating tablet for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 to 17
years old.
“We are pleased to be making this new once-daily
methylphenidate product available now and to allow doctors to
become familiar with Cotempla XR-ODT as they see patients during
the back-to-school season,” said Vipin K. Garg, Ph.D., President
and CEO of Neos Therapeutics. “This launch of our second product
demonstrates our continued commitment to improving the lives of
patients with ADHD. The positive feedback that we have received
from physicians regarding their patients who are taking our first
marketed product, Adzenys XR-ODT®, amphetamine extended-release
orally disintegrating tablets, leads us to believe that Cotempla
XR-ODT will be an attractive treatment option for patients for whom
methylphenidate is appropriate.”
The approval of Cotempla XR-ODT was supported by
a Phase 3 clinical trial in children in a laboratory classroom
setting. Treatment with Cotempla XR-ODT showed a statistically
significant improvement in ADHD symptom control compared to placebo
averaged across the classroom day (placebo-subtracted difference of
-11 [95% CI -13.9, -8.2]). Onset of effect was evident at one hour
post dose and lasted through 12 hours. No serious adverse events
were reported during the trial, and the adverse event profile
appears similar to the established safety profile for other
extended-release methylphenidate products. In addition, data from a
bioequivalence study as well as a pharmacokinetic study in children
with ADHD were also submitted.
Cotempla XR-ODT and Adzenys XR-ODT are
federally controlled substances (CII). Central nervous system
(CNS) stimulants (methylphenidate and amphetamine-containing
products) have a high potential for abuse and dependence.
Physicians should assess the risk of abuse prior to prescribing and
monitor for signs of abuse and dependence.
“The availability of Cotempla XR-ODT is good
news for the children and adolescents diagnosed with ADHD, as it
offers a wonderful new treatment option to help them manage their
symptoms,” said James C. Anderson, MD, managing physician of
Cornerstone Pediatrics at Premier in Greensboro, NC. “I personally
have patients who are excited to try this extended-release
methylphenidate product.”
IMPORTANT SAFETY INFORMATION
Cotempla XR-ODT is a
federally controlled substance (CII) because it can be abused or
lead to dependence. Keep Cotempla XR-ODT in a safe place
to protect it from theft. Selling or giving away your Cotempla
XR-ODT may cause death or harm to others and is against the
law.
Who should not take Cotempla XR-ODT?Do not give
Cotempla XR-ODT to your child if they are:
- allergic to methylphenidate or any ingredients in Cotempla
XR-ODT.
- taking or has taken an anti-depression medicine called
monoamine oxidase inhibitor (MAOI) within the past 14 days.
What is the most important information I should know
about Cotempla XR-ODT?
Cotempla XR-ODT can cause serious side
effects. Tell your healthcare provider about health conditions,
including if your child:
- has ever abused or been dependent on alcohol, prescription
medicines, or street drugs. Cotempla XR-ODT has a high chance for
abuse and can cause physical and psychological dependence.
- has any heart problems, heart defects, high blood pressure, or
a family history of these problems. This is important because
sudden death has occurred in people with heart problems or defects.
Increased blood pressure and heart rate have been reported. Your
healthcare provider should check for heart problems prior to
prescribing Cotempla XR-ODT and will check your child’s blood
pressure and heart rate regularly during treatment.
Call your healthcare provider or go to the nearest hospital
emergency room right away if your child has any signs of heart
problems such as chest pain, shortness of breath, or fainting while
during treatment.
- has mental problems, or a family history of suicide, bipolar
illness, or depression. This is important because the following
could occur: new or worse behavior and thought problems, new or
worse bipolar illness, new psychotic symptoms (hearing voices, or
seeing or believing things that are not real) or new manic
symptoms. Call your healthcare provider right away if there
are any new or worsening mental symptoms or problems during
treatment.
- develops painful and prolonged erections (priapism). Priapism
has happened in males who take products that contain
methylphenidate. Get medical help right away if your child develops
priapism.
- has circulation problems in fingers and toes (peripheral
vasculopathy, including Raynaud’s phenomenon). Fingers or toes may
feel numb, cool, painful, and/or change color from pale, to blue,
to red. Tell your healthcare provider if your child has numbness,
pain, skin color change, or sensitivity to temperature in their
fingers or toes. Call your healthcare provider right away
if any signs of unexplained wounds appear on fingers or toes while
taking Cotempla XR-ODT.
- is having slowing of growth (height and weight). Your child
should have his or her height and weight checked often while taking
Cotempla XR-ODT. Treatment may be stopped if your child is not
gaining weight or height.
- is pregnant or plans to become pregnant. It is not known if
Cotempla XR-ODT will harm the unborn baby. If your child becomes
pregnant during treatment with Cotempla XR-ODT, talk to your
healthcare provider about registering with the National Pregnancy
Registry for Psychostimulants.
- is breastfeeding, or plans to breastfeed. You and your
healthcare provider should decide if your child will take Cotempla
XR-ODT or breastfeed.
- takes any medicines, including prescription and
over-the-counter medicines (especially for depression, including
MAOIs), vitamins, and herbal supplements. Cotempla XR-ODT and some
medicines may interact with each other and cause serious side
effects, or sometimes the dose of the other medicine will need to
be adjusted.
Do not start any new medicine while
taking Cotempla XR-ODT without talking to your healthcare provider
first.What should I avoid during treatment with
Cotempla XR-ODT?
- You should avoid drinking alcohol during treatment with
Cotempla XR-ODT.
Common side effects of Cotempla XR-ODT
include:Decreased appetite, trouble sleeping, nausea,
vomiting, indigestion, stomach pain, weight loss, anxiety,
dizziness, irritability, mood swings, increased heart rate, and
increased blood pressure.
These are not all the possible side effects of
Cotempla XR-ODT. Call your healthcare provider for medical advice
about side effects.
What is Cotempla
XR-ODT?Cotempla XR-ODT is a CNS stimulant prescription
medicine used for the treatment of ADHD in children 6 to 17 years
of age. Cotempla XR-ODT is a federally controlled substance
(CII) because it contains methylphenidate that can be a target for
people who abuse prescription medicines or street
drugs. Keep Cotempla XR-ODT in a safe place to
protect it from theft. Selling or giving away your Cotempla XR-ODT
may cause death or harm to others and is against the law.
For additional safety information for Cotempla XR-ODT, click
here for Full Prescribing Information and Medication Guide and
discuss with your healthcare provider.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call
1-800-FDA-1088.
About ADHDAccording to
the Centers for Disease Control and Prevention, ADHD is one of
the most common neurodevelopment disorders of childhood and can
continue through adolescence and adulthood.i In fact, ADHD is
estimated to affect 5 percent of children and 2.5 percent of adults
in the U.S.ii Symptoms include inattentiveness, hyperactivity
and impulsiveness. These patterns of behavior are seen in many
settings (school, home, work) and can impact performance and
relationships.
Stimulant medications such as amphetamine and
methylphenidate are first-line pharmacological therapies for ADHD,
and extended-release formulations of these medications allow for
once-daily dosing.iii Most of the existing treatment options
are tablets or capsules, which need to be swallowed intact or in
some cases sprinkled on certain foods or fluids and ingested
immediately. Orally disintegrating tablets differ from traditional
tablets and capsules in that they are designed to disintegrate in
the mouth, rather than being swallowed whole.
About Neos TherapeuticsNeos
Therapeutics, Inc. (NASDAQ:NEOS) is a pharmaceutical company
focused on developing, manufacturing and commercializing products
utilizing its proprietary modified-release drug delivery technology
platforms. Adzenys XR-ODT®, amphetamine extended-release orally
disintegrating tablets, and Cotempla XR-ODT™, methylphenidate
extended-release orally disintegrating tablets, both for the
treatment of ADHD, are the first two approved products using the
Company’s extended-release (XR) orally disintegrating tablet (ODT)
technology platform (see Full Prescribing Information, including
Boxed WARNING for both Adzenys XR-ODT and Cotempla XR-ODT). Neos,
which is initially focusing on the treatment of ADHD, has submitted
a New Drug Application to the U.S. Food and Drug Administration for
one other branded product candidate that is an extended-release
amphetamine oral suspension. In addition, Neos manufactures and
markets its generic version of the branded product Tussionex®1, an
extended-release oral suspension of hydrocodone and
chlorpheniramine for the relief of cough and upper respiratory
symptoms of a cold (see Full Prescribing Information, including
Boxed WARNING). Additional information about Neos is available at
www.neostx.com.
1Tussionex® is a registered trademark of
the UCB Group of Companies.
About Adzenys XR-ODTAdzenys
XR-ODT (amphetamine) extended-release orally disintegrating tablet
is a prescription medicine used for the treatment of ADHD in
patients 6 years and above.
IMPORTANT SAFETY INFORMATION
Adzenys XR-ODT is a
federally controlled substance (CII) because it can be abused or
lead to dependence. Keep Adzenys XR-ODT in a safe place to prevent
misuse and abuse. Selling or giving away Adzenys XR-ODT may harm
others and is against the law.
Tell your doctor if you or your child has ever
abused or been dependent on alcohol, prescription medicines, or
street drugs.
Who should not take
Adzenys XR-ODT?Do not take Adzenys XR-ODT if you
or your child is:
- allergic to amphetamine or any ingredients in Adzenys
XR-ODT.
- taking or has taken an anti-depression medicine called
monoamine oxidase inhibitor (MAOI) within the past 14 days.
Adzenys XR-ODT is a
stimulant medicine. Tell your doctor about health conditions,
including if:
- you or your child has any heart problems, heart defects, high
blood pressure, or a family history of these problems. This is
important because sudden death has occurred in people with heart
problems or defects, and sudden death, stroke and heart attack have
happened in adults. Your doctor should check for heart problems
prior to prescribing Adzenys XR-ODT and will check you or your
child's blood pressure and heart rate during treatment.
Call the doctor right away if you or your child has any
signs of heart problems such as chest pain, shortness of breath, or
fainting while taking Adzenys
XR-ODT.
- you or your child has mental problems, or a family history of
suicide, bipolar illness, or depression. This is important because
the following could occur: new or worse behavior and thought
problems, new or worse bipolar illness, new psychotic symptoms
(hearing voices, believing things that are not true, are
suspicious) or new manic symptoms. Call the doctor right
away if there are any new or worsening mental symptoms during
treatment.
- you or your child has circulation problems in fingers and toes
(peripheral vasculopathy, including Raynaud's phenomenon). Fingers
or toes may feel numb, cool, painful, sensitive to temperature
and/or change color from pale, to blue, to red. Call the
doctor right away if any signs of unexplained wounds appear on
fingers or toes while taking Adzenys
XR-ODT.
- your child is having slowing of growth (height and weight).
Your child should have his or her height and weight checked often
while taking Adzenys XR-ODT. The doctor may stop treatment if a
problem is found during these check-ups.
- you or your child has kidney problems. Your doctor may lower
the dose.
- you or your child is, or plans to become pregnant.
- you or your child is breastfeeding, or plans to breastfeed. You
should not breastfeed while taking Adzenys XR-ODT.
- you or your child takes any medicines, including prescription
and over-the-counter medicines, vitamins, and herbal supplements.
Adzenys XR-ODT and some medicines may interact with each other and
cause serious side effects.
Do not start any new medicine while
taking Adzenys XR-ODT without talking to your doctor
first.
What should I avoid while
taking Adzenys XR-ODT?
- You should avoid drinking alcohol during treatment with Adzenys
XR-ODT
Common side effects of
Adzenys XR-ODT include:
- Decreased appetite and problems sleeping.
- Children 6 - 12 Years also include: Stomach
pain, extreme mood change, vomiting, nervousness, nausea, and
fever.
- Children 13 - 17 Years also include: Stomach
pain and weight loss.
- Adults also include: Dry mouth, headache,
weight loss, nausea, anxiety, restlessness, dizziness, fast heart
beat, diarrhea, weakness, and urinary tract infections.
These are not all the possible side effects of
Adzenys XR-ODT. Call your doctor for medical advice about side
effects.
What is Adzenys XR-ODT?Adzenys
XR-ODT is a prescription medicine used for the treatment of ADHD in
patients 6 years and above.
For additional safety information for Adzenys
XR-ODT, click here for Full Prescribing
Information and Medication Guide and
discuss with your doctor.
You are encouraged to report negative
side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call
1-800-FDA-1088.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of
1995, including statements concerning the commercialization of
Adzenys XR-ODT and Cotempla XR-ODT, the regulatory submissions,
marketing plans and timing and the therapeutic potential of
NT-0201. Forward-looking statements generally relate to future
events or our future financial or operating performance. In some
cases, you can identify forward-looking statements because they
contain words such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential” or
“continue” or the negative of these words or other similar terms or
expressions that concern our expectations, strategy, plans or
intentions. These forward-looking statements reflect our current
views about our expectations, strategy, plans, prospects or
intentions, which are based on the information currently available
to us and on assumptions we have made. Although we believe
that our plans, intentions, expectations, strategies and prospects
as reflected in or suggested by those forward-looking statements
are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially
from those described in the forward-looking statements and will be
affected by a variety of risks and factors that are beyond our
control including, without limitation, our ability to successfully
obtain regulatory approval of our NT-0201 product candidate,
the timing of such approval, our ability to market and sell
our product candidates and other risks set forth under the
caption “Risk Factors” in our most recently filed Annual Report on
Form 10-K as updated by our subsequently filed
other SEC filings, including our Quarterly
Report(s) on Form 10-Q. We assume no obligation to update
any forward-looking statements contained in this document as a
result of new information, future events or otherwise.
Cotempla XR-ODT™ and Adzenys XR-ODT® are
trademarks of NEOS Therapeutics, Inc. ©2017 NEOS Therapeutics, Inc.
All rights reserved.
N00235 08/17
_______________________i Centers for
Disease Control. Attention-Deficit/Hyperactivity Disorder (ADHD).
Available at http://www.cdc.gov/ncbddd/adhd/facts.html. Accessed
June 8, 2017.ii American Psychiatric Association. (2013) Diagnostic
and Statistical Manual of Mental Disorders, Fifth Edition,
Arlington, VA.iii Chew RH, Hales RE, Yudofsky SC: What Your
Patients Need to Know About Psychiatric Medications, Second
Edition. Washington, DC, American Psychiatric Publishing, 2009.
CONTACTS:
Thomas P. McDonnell
Chief Commercial Officer
Neos Therapeutics
(484) 477‐6729
tmcdonnell@neostx.com
Richard I. Eisenstadt
Chief Financial Officer
Neos Therapeutics
(972) 408-1389
reisenstadt@neostx.com
Sarah McCabe
Investor Relations
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com
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