Neos Therapeutics, Inc. (Nasdaq:NEOS), a
pharmaceutical company focused on developing, manufacturing and
commercializing innovative extended-release products using its
proprietary modified-release drug delivery technologies, today
announced that the U.S. Food and Drug Administration (FDA) has
approved Adzenys ER™ (amphetamine) Extended-Release Oral
Suspension. Neos Therapeutics is the only company to offer both
branded amphetamine and methylphenidate products in
extended-release dosage forms. Once commercially available, Adzenys
ER oral suspension will be the third Neos extended release product
for the treatment of Attention Deficit Hyperactivity Disorder
(ADHD). The other Neos extended-release products for the treatment
of ADHD are Adzenys XR-ODT® (amphetamine) Extended-Release Orally
Disintegrating Tablets and Cotempla XR-ODT™ (methylphenidate)
Extended-Release Orally Disintegrating Tablets.
“This FDA approval unlocks yet another treatment
option for ADHD patients and their caregivers who are seeking a
liquid extended-release amphetamine product and provides a
different dosage form of our already-approved Adzenys XR-ODT,” said
Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “Neos
has now successfully gained FDA approval of three ADHD products in
just two years. We are very proud of this accomplishment and
believe it speaks to the strength of our technology platform. Our
commitment to ADHD and addressing the individual needs of patients
is clear, and we look forward to the commercial launch of this
product in early 2018.”
Adzenys ER, formerly referred to as NT-0201, is
a once-daily, extended-release liquid medication that does not
require refrigeration or reconstitution at the pharmacy level. It
utilizes the same proprietary modified-release drug delivery
technology as Adzenys XR-ODT, thereby providing healthcare
providers the option to transition appropriate patients from liquid
to ODT formulations. Both Adzenys ER and Adzenys XR-ODT are
bioequivalent to Adderall XR. Approved in January 2016, Adzenys
XR-ODT is entering its second year on the market and is now the
fastest growing alternative dosage form product for the treatment
of ADHD.i
Adzenys ER, Adzenys XR-ODT, and Cotempla
XR-ODT are federally controlled substances (CII). Central nervous
system (CNS) stimulants (amphetamine and methylphenidate-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.
“It is important for physicians to have a wide
choice of medicines to help our patients with ADHD manage their
symptoms,” said Michael Feld, MD, a Northbrook, IL-based Child,
Adolescent, and Adult Psychiatrist specializing in the treatment of
ADHD. “As a once-daily liquid formulation, Adzenys ER can play a
role in meeting the individual needs of my patients.”
Adzenys ER will be commercially available in
early 2018.
IMPORTANT SAFETY INFORMATION for Adzenys XR-ODT
and Adzenys ER
Adzenys XR-ODT and Adzenys ER
are federally controlled substances (CII) because they can
be abused or lead to dependence. Keep both Adzenys XR-ODT and
Adzenys ER in a safe place to prevent misuse and abuse.
Selling or giving away Adzenys XR-ODT or Adzenys ER 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 or
Adzenys ER?Do not take Adzenys XR-ODT or Adzenys ER if you
or your child is:
- allergic to amphetamine or any ingredients in Adzenys XR-ODT or
Adzenys ER.
- taking or has taken an anti-depression medicine called
monoamine oxidase inhibitor (MAOI) within the past 14 days.
Adzenys XR-ODT and Adzenys ER are
stimulant medicines. 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 either Adzenys XR-ODT or Adzenys ER 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 either Adzenys XR-ODT or
Adzenys ER.
- 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 either Adzenys XR-ODT or Adzenys
ER.
- you or your child is having symptoms of serotonin syndrome
which may happen when Adzenys XR-ODT or Adzenys ER is taken with
certain other medicines and may be life threatening. Call
your doctor or go to the nearest hospital emergency room if you
have any of the following symptoms: agitation,
hallucinations, coma or other changes in mental status, problems
controlling your movements or muscle twitching, fast heartbeat,
high or low blood pressure, sweating or fever, muscle stiffness or
tightness, nausea, vomiting or diarrhea.
- your child is having slowing of growth (height and weight).
Your child should have his or her height and weight checked often
while taking either Adzenys XR-ODT or Adzenys ER. 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. If you or
your child becomes pregnant during treatment with either Adzenys
XR-ODT or Adzenys ER, talk to your doctor about registering with
the National Pregnancy Registry for Psychostimulants.
- you or your child is breastfeeding, or plans to breastfeed. You
or your child should not breastfeed while taking either Adzenys
XR-ODT or Adzenys ER.
- you or your child takes any medicines, including prescription
and over-the-counter medicines, vitamins, and herbal supplements.
Adzenys XR-ODT and Adzenys ER and some medicines may interact with
each other and cause serious side effects.
Do not start any new medicine while
taking either Adzenys XR-ODT or Adzenys ER without talking to your
doctor first.
What should I avoid while taking Adzenys
XR-ODT or Adzenys ER?
Common side effects for Adzenys XR-ODT
and Adzenys ER include:
- Children 6 – 12 Years: Decreased appetite,
problems sleeping, stomach pain, extreme mood change, vomiting,
nervousness, nausea, and fever.
- Children 13 – 17 Years: Decreased appetite,
problems sleeping, stomach pain and weight loss, and
nervousness.
- Adults: Dry mouth, decreased appetite,
problems sleeping, 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 and Adzenys ER. Call your doctor for medical advice
about side effects.
What are Adzenys XR-ODT and Adzenys
ER?Adzenys XR-ODT and Adzenys ER are central nervous
system (CNS) stimulant prescription medicines used for the
treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
people 6 years of age and older. Adzenys XR-ODT and Adzenys
ER are federally controlled substances (CII) because they contain
amphetamine that can be a target for people who abuse prescription
medicines or street drugs. Keep both Adzenys XR-ODT
or Adzenys ER in a safe place to protect it from theft. Selling or
giving away your Adzenys XR-ODT or Adzenys ER may cause death or
harm to others and is against the law.
"For additional safety information for Adzenys
XR-ODT, click here for the Medication Guide and Prescribing
Information and discuss with your doctor"
"For additional safety information for Adzenys
ER, click here for the Medication Guide and Prescribing Information
and discuss with your doctor"
IMPORTANT SAFETY INFORMATION for
Cotempla XR-ODT
What is Cotempla
XR-ODT?Cotempla XR-ODT is a central nervous system (CNS)
stimulant prescription medicine used for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of
age.
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
the 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 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 the 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.
For additional safety information, 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.ii In fact, ADHD is
estimated to affect 5 percent of children and 2.5 percent of adults
in the U.S.iii 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.iv Most of the existing treatment options are
traditional tablets or capsules, which need to be swallowed intact
or in some cases sprinkled on certain foods or fluids and ingested
immediately. Orally disintegrating tablet and liquid products are
considered alternative dosage forms for treating ADHD.
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 (see Full Prescribing Information, including
Boxed WARNING), Cotempla XR-ODT™ (methylphenidate) extended-release
orally disintegrating tablets (see Full Prescribing Information,
including Boxed WARNING), and Adzenys ER™ (amphetamine)
extended-release oral suspension (see Full Prescribing Information,
including Boxed WARNING), all for the treatment of ADHD, are the
first three approved branded products using the company’s
extended-release technology platform. 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.
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 ER, Adzenys XR-ODT and Cotempla XR-ODT, the marketing plans
and timing and the therapeutic potential of Adzenys ER, Adzenys
XR-ODT and Cotempla XR-ODT. 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 launch the commercialization of Adzenys ER,
the timing of such launch, 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.
CONTACTS:
Thomas P. McDonnell Chief Commercial Officer
Neos Therapeutics (484) 477‐6729 tmcdonnell@neostx.com
Richard I. EisenstadtChief Financial OfficerNeos
Therapeutics(972) 408-1389reisenstadt@neostx.com
Sarah McCabe Investor Relations Stern Investor
Relations, Inc. (212) 362-1200 sarah@sternir.com
Adzenys ER™, Adzenys XR-ODT®, and Cotempla
XR-ODT™ are trademarks of NEOS Therapeutics, Inc. ©2017 NEOS
Therapeutics, Inc. All rights reserved.
____________________________ i
Quintiles IMS Health National Prescription Audit, June 2016-June
2017. ii Centers for Disease Control.
Attention-Deficit/Hyperactivity Disorder (ADHD). Available at
http://www.cdc.gov/ncbddd/adhd/facts.html. Accessed June 8,
2017. iiiAmerican Psychiatric Association. (2013)
Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition, Arlington, VA. iv Chew RH, Hales RE, Yudofsky
SC: What Your Patients Need to Know About Psychiatric Medications,
Second Edition. Washington, DC, American Psychiatric Publishing,
2009.
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