US modified-release drug delivery technologies specialist Neos Therapeutics has received approval from the US Food and Drug Administration for Adzenys ER (amphetamine) extended-release oral suspension, with the news sending the firm’s share more than 5% lower in after-hours trading.
Adzenys ER will be commercially available in early 2018, the company noted.
Texas-based Neos Therapeutics says it is the only company to offer both branded amphetamine and methylphenidate products in extended-release dosage forms. Once commercially available, Adzenys ER oral suspension will be the third Neos extended release product for the treatment of attention deficit hyperactivity disorder (ADHD). The other Neos extended-release products for the treatment of ADHD are Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets, a bioequivalent to Adderall XR (mixed amphetamine salts), which is marketed by Ireland-based pharma company Shire (LSE: SHP), and Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets.
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