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 XR®1), 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 XR®1 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.
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.