DALLAS and FORT WORTH, Texas, May 16, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc.
(Nasdaq:NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the
treatment of attention-deficit/hyperactivity disorder (ADHD), today announced that Adzenys XR-ODT™ is in distribution channels and
is now available to prescribe to patients with ADHD in the United States.
Adzenys XR-ODT was approved by the U.S. Food and Drug Administration (FDA) in January for the treatment of ADHD
in patients six years and older and is the first and only extended-release orally disintegrating tablet (XR-ODT) for the treatment
of ADHD. Adzenys XR-ODT is bioequivalent to Adderall XR®1, one of the most commonly prescribed medications for the
treatment of ADHD.
“The availability of the first and only extended-release orally disintegrating tablet for the treatment of
ADHD represents a significant milestone for patients and families that struggle with ADHD,” said Thomas McDonnell, Chief Commercial
Officer of Neos. “Adzenys XR-ODT offers patients, caregivers and health care providers an important new option for the treatment of
ADHD that was designed with patients in mind.”
Adzenys XR-ODT is an orange-flavored tablet that disintegrates in the mouth without water. The medication is
available in six dosage strengths and has the convenience of once-daily dosing.
“The availability of Adzenys XR-ODT marks the first branded product launch for Neos using our proprietary
extended-release, orally disintegrating tablet technology,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics.
“Neos is committed to addressing individual patient needs by delivering new treatment options for those with chronic disorders like
ADHD. In addition to Adzenys XR-ODT, we look forward to pursuing FDA approval of our two additional late-stage product candidates
for ADHD, and utilizing our technology platform in other therapeutic areas.”
Visit www.AdzenysXRODT.com for more information.
What is Adzenys XR-ODT?
Adzenys XR-ODT is a central nervous system stimulant prescription medicine used for the treatment of ADHD in patients 6 years and
older.
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?
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.
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
To report suspected adverse reactions, contact Neos Therapeutics, Inc. at 1-888-219-1789. 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 ADHD
According to the Centers for Disease Control and Prevention, ADHD is one of the most common childhood disorders and can continue
through adolescence and adulthood2. In fact, ADHD is estimated to affect 5 percent of children and 2.5 percent of adults
in the U.S3. Symptoms include inattentiveness, hyperactivity and impulsiveness3. 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 the standard of care for treating ADHD, and
extended-release (XR) formulations of these medications allow for once-daily dosing4. Most of the existing treatment
formulations 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 Therapeutics
Neos Therapeutics, Inc. is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its
proprietary modified‐release drug delivery technology platforms. Adzenys XR-ODT is the first approved product using the Company’s
XR-ODT technology platform. Neos, which is initially focusing on the treatment of ADHD, has two other branded product candidates
that are XR medications in ODT or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent
of the branded product Tussionex®5, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief
of cough and upper respiratory symptoms of a cold.
Special Note Regarding Forward‐Looking Statements:
This press release contains forward‐looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, including statements concerning FDA approval and Cotempla XR-ODT and development of future product
candidates. 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 identify other potential future product candidates, physician
prescribing behavior, market acceptance of Adzenys XR-ODT 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. We assume no
obligation to update any forward-looking statements contained in this document as a result of new information, future events or
otherwise.
1 Adderall XR® is a registered trademark of Shire LLC.
2 Centers for Disease Control. Attention-Deficit/Hyperactivity Disorder (ADHD). http://www.cdc.gov/ncbddd/adhd/facts.html Accessed May 10, 2016.
3 American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders
(5th ed.), Washington, D.C.
4 Chew RH, Hales RE, Yudofsky SC: What Your Patients Need to Know About Psychiatric Medications, Second
Edition. Washington, D.C., American Psychiatric Publishing, 2009
5 Tussionex® is a registered trademark of the UCB Group of Companies
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 David Carey Investor Relations Lazar Partners (212) 867-1768 dcarey@lazarpartners.com
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