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DALLAS and FORT WORTH, Texas, Jan. 10, 2018 (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 and orally disintegrating tablet (ODT) technology platforms, today announced that study findings for two of its Attention Deficit/Hyperactivity Disorder (ADHD) medications, Cotempla XR-ODT™ (methylphenidate) Extended-Release Orally Disintegrating Tablets and Adzenys ER™ (amphetamine) Extended-Release Oral Suspension, will be presented in three posters at the upcoming 2018 Annual Meeting of the American Professional Society of ADHD and Related Disorders (APSARD), on January 12-14, 2018, at the Marriott Wardman Park hotel in Washington D.C.
All three posters will be presented on Saturday, January 13, 2018, during the 12:30 PM – 2:30 PM session:
“The presentation of these data at APSARD is a great opportunity for Neos to reach the ADHD professional community,” stated Dr. Vipin Garg, President and CEO of Neos Therapeutics. “We are excited to share the results of these studies with mental health experts who are as committed as we are to helping to improve the lives of patients with ADHD.”
IMPORTANT SAFETY INFORMATION for Cotempla XR-ODT
Cotempla XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep 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:
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. Cotempla XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. 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.
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:
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 adulthood.i In fact, ADHD is estimated to affect 5 percent of children and 2.5 percent of adults in the U.S.ii 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 treating ADHD, and extended-release formulations of these medications allow for once-daily dosing.iii Most of the existing treatment options are tablets or capsules, which need to be swallowed intact or in some cases sprinkled on certain foods or fluids and ingested immediately.
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 products using the Company’s extended-release technology platform. Additional information about Neos is available at www.neostx.com.
Any statements in this press release about future expectations, plans and prospects for Neos Therapeutics, Inc., including statements about Neos’ future expectations and plans to defend and enforce its intellectual property rights and other statements containing the words "will," "would," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related governmental approvals of the settlement and license agreement, Neos’ ability to protect its intellectual property rights, uncertainties related to litigation Neos is involved or may become involved, uncertainties inherent in the initiation of future clinical trials, expectations of expanding ongoing clinical trials and other factors discussed in the "Risk Factors" section of Neos’ Annual Report on Form 10-K for the year ended December 31, 2016, which is on file with the SEC, as updated by any subsequently filed SEC filings, including Neos’ Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and Neos expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Vice President Clinical Affairs
Richard I. Eisenstadt
Chief Financial Officer
Stern Investor Relations, Inc.
Adzenys XR-ODT®, Cotempla XR-ODT™ and Adzenys ER™ are trademarks of NEOS Therapeutics, Inc. ©2018 NEOS Therapeutics, Inc. All rights reserved
i Centers for Disease Control. Attention-Deficit/Hyperactivity Disorder (ADHD). Available at http://www.cdc.gov/ncbddd/adhd/facts.html. Accessed January 8, 2018.
ii American Psychiatric Association. (2013) Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Arlington, VA.
iii 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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