Neos Therapeutics Announces U.S. Launch of Adzenys XR-ODT™ (Amphetamine Extended-Release Orally Disintegrating Tablet) for the Treatment of ADHD in Patients Six Years and Older
Adzenys XR-ODT was approved by the
“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
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
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?
- drinking alcohol
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.
To report suspected adverse reactions, contact
According to the
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.
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
1 Adderall XR® is a registered trademark of
4 Chew RH, Hales RE, Yudofsky SC: What Your Patients Need to Know About Psychiatric Medications, Second Edition.
5 Tussionex® is a registered trademark of the
Thomas P. McDonnellChief Commercial Officer Neos Therapeutics (484) 477‐6729 firstname.lastname@example.org Richard I. Eisenstadt Chief Financial Officer Neos Therapeutics (972) 408-1389 email@example.com David CareyInvestor Relations Lazar Partners(212) 867-1768 firstname.lastname@example.org