FDA approves Adzenys XR-ODT

Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for ADHD 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 adulthood. In fact, ADHD is estimated to affect 5 percent of children and 2.5 percent of adults in the U.S. 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 the standard of care for treating ADHD, and extended-release (XR) formulations of these medications allow for once-daily dosing 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.

FDA approves Adzenys XR-ODT

Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for ADHD 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 adulthood. In fact, ADHD is estimated to affect 5 percent of children and 2.5 percent of adults in the U.S. 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 the standard of care for treating ADHD, and extended-release (XR) formulations of these medications allow for once-daily dosing 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.