Corporate News Blog - Neos Therapeutics Receives FDA’s Approval for Adzenys ER(TM) Extended-Release Oral Suspension, its Third Treatment for ADHD

LONDON, UK / ACCESSWIRE / September 19, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Neos Therapeutics, Inc. (NASDAQ: NEOS), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=NEOS. The Company announced on September 15, 2017, that the US Food and Drug Administration (FDA) has approved Adzenys ER™ (amphetamine) Extended-Release Oral Suspension. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Presently, Neos Therapeutics is the only Company that offers both branded amphetamine and methylphenidate products in extended-release dosage forms. Adzenys ER™ oral suspension is the third Neos Therapeutics extended-release product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

About ADHD

As per the Center for Disease Control and Prevention, ADHD is amongst the most common neurodevelopment disorders of childhood. Sometimes, it also continues up till adolescence and adulthood. It is anticipated that it affects around 5% of children and 2.5% of adults in the US currently. Inattentiveness, hyperactivity, and impulsiveness are some of the common symptoms of ADHD, which impact both performance as well as relationships.

Treatment for ADHD

  • Stimulant medications such as amphetamine and methylphenidate are the first-line pharmacological therapies for ADHD. The extended-release formulations of these medications allow for once-daily dosing.
  • The existing treatment options comprise of traditional tablets or capsules that need to be swallowed intact or sprinkled on certain foods or fluids and ingested immediately. Alternate dosage includes orally disintegrating tablet and liquid products.
  • Once Adzenys ER™ oral suspension becomes commercially available, it would be the third Neos Therapeutics extended-release product for the treatment of ADHD. Other Neos Therapeutics extended-release products for the treatment of ADHD include Adzenys XR-ODT® (amphetamine) Extended-Release Orally Disintegrating Tablets, and Cotempla XR-ODT™ (methylphenidate) Extended-Release Orally Disintegrating Tablets.

About Adzenys ER™

  • Adzenys ER™, which was formerly referred to as NT-0201, is a once-daily, extended-release liquid medication for ADHD. Adzenys ER™ is based on the same proprietary modified-release drug delivery technology as Adzenys XR-ODT®. It thus offers healthcare providers the choice to transition suitable patients from liquid to ODT formulations. Adzenys ER™ does not require refrigeration or reconstitution at the pharmacy level.
  • Both Adzenys XR-ODT® and Adzenys ER™ are central nervous system (CNS) stimulant prescription medicines used for the treatment of ADHD in people of 6 years of age and older. Both contain amphetamine, which can be a target for people who abuse prescription medicines or street drugs. Thus, they are federally controlled substances. Both Adzenys ER™ and Adzenys XR-ODT® are bioequivalent to Adderall XR.
  • Adzenys XR-ODT® was approved in January 2016 and is now entering its second year in the market. In fact, it has become the fastest growing alternative dosage form product for the treatment of ADHD.

Need to Control Abuse and Dependence on Adzenys ER™

As mentioned above, Adzenys ER™, Adzenys XR-ODT®, and Cotempla XR-ODT™ are federally controlled substances. They carry a huge risk of being abused and can lead to dependence. Therefore, physicians will need to assess the risk of abuse before prescribing this drug. They also need to constantly monitor for signs of abuse and dependence. Thus, both Adzenys XR-ODT® and Adzenys ER™ are to be kept in a safe place and protected from theft. Selling or giving away Adzenys XR-ODT® or Adzenys ER™ could harm others and is also against the law.

Neos Therapeutics' Commitment to ADHD

Vipin K. Garg, Ph.D., President and CEO at Neos Therapeutics, stated that the FDA's approval would unlock yet another treatment option for ADHD patients and caregivers, who are constantly looking for a liquid extended-release amphetamine product. Adzenys ER™ is a different dosage form of the already-approved Adzenys XR-ODT®. Neos Therapeutics has successfully attained FDA's approval for three ADHD products in just two years, which denotes the strength of the Company's technology platform. Proud of this achievement, Garg reaffirmed Neos Therapeutics' commitment to ADHD and in addressing the individual needs of patients. He looks forward to the commercial launch of the product in early 2018.

Wider Treatment Options for Physicians

Michael Feld, MD, a Northbrook, IL-based Child, Adolescent, and Adult Psychiatrist specializing in the treatment of ADHD, mentioned that it is critical for physicians to have a wide choice of medicines to help ADHD patients manage their symptoms. As a once-daily liquid formulation, Adzenys ER™ could play a role in meeting the individual needs of patients.

Last Close Stock Review

Neos Therapeutics' share price finished yesterday's trading session at $8.70, dropping 5.43%. A total volume of 2.30 million shares have exchanged hands, which was higher than the 3-month average volume of 774.55 thousand shares. The Company's stock price rallied 29.85% in the last one month, 20.83% in the past six months, and 4.19% in the previous twelve months. Additionally, the stock skyrocketed 48.72% since the start of the year. The stock currently has a market cap of $238.99 million.

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