Neos Therapeutics, Inc. Announces FDA Accepts NDA Filing for Extended Release Amphetamine Polistirex for the Once-Daily Treatment of ADHD
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Neos Therapeutics, Inc., a specialty pharmaceutical company that develops FDA approved drugs utilizing its innovative drug delivery technologies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) 505(b)(2) filing for NT0202. The product is an Extended Release (XR) Orally Disintegrating Tablet (ODT) formulation of Amphetamine Polistirex developed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
NT0202 is manufactured using Neos' proprietary extended-release technology and Neos is seeking approval to both manufacture and market the product in the U.S. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is targeted for completion by October 28, 2013.
If approved, NT0202 will provide a novel extended release formulation alternative to currently available ADHD formulations. Neos believes that upon approval NT0202 would be the first once-daily, extended-release (XR) Orally Disintegrating Tablet (ODT) available for patients with ADHD. Not only children, but up to 40% of American adults have difficulty taking pills according to a Harris Interactive Survey. NT0202 will provide a convenient, easy to use dosage form that can be taken without water and is an option for patients of all ages who have difficulty, or don't like to swallow pills.
About Neos Therapeutics, Inc.
Neos Therapeutics Inc. is a specialty pharmaceutical company focused on the development, manufacture and sale of FDA approved drug products which utilize the Company's proprietary delivery technologies. Neos' drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies, that deliver controlled-release (CR) small molecule APIs in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are FDA-approved and known to be safe and effective, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA's 505(b)(2) New Drug Application (NDA) approval process. For more information, visit www.neostx.com.
Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, and Rapidly Disintegrating Ionic Masking™ and RDIM™ are trademarks of Neos Therapeutics, Inc.