Neos Therapeutics Submits NDA for Amphetamine Extended-Release Liquid Suspension Drug Candidate, Amphetamine, for the Treatment of ADHD

Neos Therapeutics a pharmaceutical company focused on developing and commercializing innovative extended-release (XR) products for the treatment of attention-deficit hyperactivity disorder (ADHD), announced that it has submitted a NDA to the U.S.

FDA for its Amphetamine XR oral suspension drug candidate, NT-0201, an ADHD medication based on its proprietary modified‐release drug delivery technology platforms.

“This NDA submission for NT-0201 is another important milestone for our company, as we continue to build out our ADHD product portfolio,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “Additionally, we expect to resubmit the NDA for Cotempla XR-ODT™, our methylphenidate extended-release orally disintegrating tablet, this quarter. By the fall of 2017, with NT-0201 and Cotempla XR-ODT, if approved, and our already marketed product, Adzenys XR-ODT, we hope to offer patient-friendly treatment options for both of the stimulant medications that are most widely prescribed for the treatment of ADHD.

”NT-0201 is the company’s second extended-release amphetamine product candidate for the treatment of ADHD. The first, an extended-release orally disintegrating tablet, Adzenys XR-ODTTM, was approved by the FDA in January and was launched in May 2016. NT-0201 is a once-daily, extended-release liquid medication that does not require refrigeration or reconstitution at the pharmacy level. If approved, NT-0201 is designed to provide an additional treatment option for patients with ADHD.

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-ODTTM, indicated for the treatment of ADHD in patients 6 years of age and older, 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 oral suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®1, an XR oral suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold. 

Richard Eisenstadt
Chief Financial Officer
Neos Therapeutics
(972) 408-1389 

Sarah McCab
Stern Investor Relations, Inc.
(212) 362-1200