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FDA Approves Adzenys XR-ODT

Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for ADHD

DALLAS and FORT WORTH, Texas, Jan. 27, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq:NEOS), 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 the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.

“The novel features of an extended-release orally disintegrating tablet, which is dosed once daily and disintegrates in the mouth, make Adzenys XR-ODT attractive for use in both children (six years and older) and adults,” said Dr. Alice Mao, Medical Director, Memorial Park Psychiatry in Houston, TX.

Adzenys XR-ODT was approved by the FDA via the 505(b)(2) regulatory pathway. The clinical program demonstrated that Adzenys XR-ODT is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR1), one of the most commonly prescribed medications for the treatment of ADHD. Adzenys XR-ODT will be available in six dosage strengths, equivalent to the Adderall XR1 dosage strengths, thus allowing healthcare providers to individualize the dose.

“This first ever FDA approval of a product using our proprietary extended-release, orally disintegrating tablet technology is an important milestone for Neos. We believe that Adzenys XR-ODT will provide an important innovation for treatment in the ADHD market, and we intend to begin educating healthcare providers about our exciting new product immediately. Our full field force launch and product shipments will begin in the second quarter of 2016. We look forward to developing other treatment options for patients utilizing our technology platforms, both in ADHD and beyond,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics.

About ADHD

According to the National Institute of Mental Health, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood2. 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 impulsiveness3. 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 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.

About Adzenys XR-ODT

Adzenys XR-ODT is the first and only FDA-approved extended-release orally disintegrating tablet for the treatment of ADHD in patients 6 years and older. Adzenys XR-ODT contains amphetamine loaded onto a mixture of immediate release and polymer-coated, delayed-release resin particles. Adzenys XR-ODT is patent-protected and is not a generic of amphetamine mixed salts XR capsules.

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 Tussionex5, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.

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 physician prescribing behaviors, capabilities of Adzenys XR-ODT and development of future product candidates. 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 identify other potential future product candidates, physician prescribing behavior, market acceptance of Adzenys XR-ODT and other risks set forth under the caption “Risk Factors” in our most recently filed Quarterly Report on Form 10-Q as updated by our subsequently filed other SEC filings. We assume no obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

  1. Adderall XR® is registered to Shire plc.
  2. National Institute of Mental Health. Attention Deficit Hyperactivity Disorder. Accessed January 11, 2016 at http://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml.
  3. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders: DSM-5™. Washington, D.C.
  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

Source: Neos Therapeutics, Inc.

Posted: January 2016

Adzenys XR-ODT (amphetamine) FDA Approval History

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