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FDA Approves Adzenys ER

Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension for ADHD

DALLAS and FORT WORTH, Texas, Sept. 15, 2017 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release products using its proprietary modified-release drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved Adzenys ER™ (amphetamine) Extended-Release Oral Suspension. Neos Therapeutics is the only company to offer both branded amphetamine and methylphenidate products in extended-release dosage forms. Once commercially available, Adzenys ER oral suspension will be the third Neos extended release product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The other Neos extended-release products for the treatment of ADHD are Adzenys XR-ODT® (amphetamine) Extended-Release Orally Disintegrating Tablets and Cotempla XR-ODT™ (methylphenidate) Extended-Release Orally Disintegrating Tablets.

“This FDA approval unlocks yet another treatment option for ADHD patients and their caregivers who are seeking a liquid extended-release amphetamine product and provides a different dosage form of our already-approved Adzenys XR-ODT,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “Neos has now successfully gained FDA approval of three ADHD products in just two years. We are very proud of this accomplishment and believe it speaks to the strength of our technology platform. Our commitment to ADHD and addressing the individual needs of patients is clear, and we look forward to the commercial launch of this product in early 2018.”

Adzenys ER, formerly referred to as NT-0201, is a once-daily, extended-release liquid medication that does not require refrigeration or reconstitution at the pharmacy level. It utilizes the same proprietary modified-release drug delivery technology as Adzenys XR-ODT, thereby providing healthcare providers the option to transition appropriate patients from liquid to ODT formulations. Both Adzenys ER and Adzenys XR-ODT are bioequivalent to Adderall XR. Approved in January 2016, Adzenys XR-ODT is entering its second year on the market and is now the fastest growing alternative dosage form product for the treatment of

ADHD.i

Adzenys ER, Adzenys XR-ODT, and Cotempla XR-ODT are federally controlled substances (CII). Central nervous system (CNS) stimulants (amphetamine and methylphenidate-containing products) have a high potential for abuse and dependence. Physicians should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence. “It is important for physicians to have a wide choice of medicines to help our patients with ADHD manage their symptoms,” said Michael Feld, MD, a Northbrook, IL-based Child, Adolescent, and Adult Psychiatrist specializing in the treatment of ADHD. “As a once-daily liquid formulation, Adzenys ER can play a role in meeting the individual needs of my patients.” Adzenys ER will be commercially available in early 2018.

About ADHD

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.ii 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 dosing.iv 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. Orally disintegrating tablet and liquid products are considered alternative dosage forms for treating 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.

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 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 Adzenys ER, 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.

i Quintiles IMS Health National Prescription Audit, June 2016-June 2017.
ii Centers for Disease Control. Attention-Deficit/Hyperactivity Disorder (ADHD). Available at http://www.cdc.gov/ncbddd/adhd/facts.html. Accessed June 8, 2017.
iiiAmerican 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 Edition. Washington, DC, American Psychiatric Publishing, 2009.

Source: Neos Therapeutics, Inc.

Posted: September 2017

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