Neos announces U.S. launch of Adzenys XR-ODT for ADHD

Neos Therapeutics, Inc., 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 for 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?

• 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.

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 1-888-319-1789. 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 adulthood[2]. 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 impulsiveness[3]. 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 dosing[4]. 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.

[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, Fifth Edition, Arlington, VA.

[4] Chew RH, Hales RE, Yudofsky SC: What Your Patients Need to Know About Psychiatric Medications, Second Edition. Washington, DC, American Psychiatric Publishing, 2009

[5] Tussionex® is a registered trademark of the UCB Group of Companies