DALLAS/FORT WORTH, Texas, Oct. 02, 2017 (GLOBE NEWSWIRE) -- 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 technologies, today announced the US launch of Cotempla XR-ODTTM. Commercially available in select markets since September 2017, Cotempla XR-ODT 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 evaluated Cotempla XR-ODT in a laboratory classroom study in children with ADHD and the data showed a statistically significant improvement in ADHD symptoms compared to placebo averaged across the classroom day,” said Andrew J. Cutler, MD, Executive Vice President and Chief Medical Officer of Meridien Research in Tampa, Florida and a principal investigator in the Cotempla XR-ODT clinical studyi. “Onset of effect was evident at one hour post-dose and symptom control lasted through 12 hours. In addition, there was a 61% improvement in ADHD symptoms when treated with Cotempla XR-ODT at one hour versus baseline.”
No serious adverse events were reported during the trial, and the adverse events profile appears similar to the established tolerability profile for other extended-release methylphenidate products (most common adverse events for Cotempla XR-ODT are decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure). Cotempla XR-ODT was approved by the US Food and Drug Administration (FDA) on June 19, 2017.
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.
“We are very encouraged by the feedback we have been getting from physicians about Cotempla XR-ODT,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “With the availability of Cotempla XR-ODT, Adzenys XR-ODT® (amphetamine) Extended-Release Orally Disintegrating Tablets, and the recent approval of Adzenys ER™ (amphetamine) Extended-Release Oral Suspension, Neos is providing physicians with additional options to help address the individual needs of their patients with ADHD.”
ADDITIONAL IMPORTANT SAFETY INFORMATION for Cotempla XR-ODT
Who should not take Cotempla XR-ODT?
Do not give Cotempla XR-ODT to your child if they are:
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:
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?
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 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.
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, abuse and theft. Selling or giving away your 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:
Adzenys XR-ODT and Adzenys ER are stimulant medicines. Tell your doctor about health conditions, including if:
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:
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.
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.
According 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 adulthoodii. 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 dosingiv. 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. Additional dosage forms such as oral disintegrating tablets and liquid formulations help physicians meet the various needs of individual patients with ADHD.
About Neos Therapeutics
Neos 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.
This 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 Cotempla XR-ODT, 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.
Thomas P. McDonnell
Chief Commercial Officer
Richard I. Eisenstadt
Chief Financial Officer
Stern Investor Relations, Inc.
Adzenys ER™, Adzenys XR-ODT®, and Cotempla XR-ODT™ are trademarks of NEOS Therapeutics, Inc. ©2017 NEOS Therapeutics, Inc. All rights reserved.
i Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. (2017) Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with ADHD in the Laboratory Classroom Setting. J Child Adolesc Psychopharmacol. 27(1):66-74.
ii Centers for Disease Control. Attention-Deficit/Hyperactivity Disorder (ADHD). Available at http://www.cdc.gov/ncbddd/adhd/facts.html. Accessed September 28, 2017.
iii American 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 Editions. Washington, DC, American Psychiatric Publishing, 2009.