Neos Therapeutics (NEOS) Announces Submission of NT-0201 NDA to U.S. FDA

November 17, 2016 8:02 AM EST

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Neos Therapeutics, Inc. (Nasdaq: NEOS) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (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.

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