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news.Neos Therapeutics has secured approval from the US Food and Drug Administration (FDA) for Adzenys XR-ODT to treat attention deficit hyperactivity disorder (ADHD) in patients six years and older.
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Adzenys XR-ODT is bioequivalent to an earlier approved mixed amphetamine salts extended-release capsule (Adderall XR), which the company claims is one of the most commonly prescribed medications to treat ADHD.
Adzenys XR-ODT features amphetamine loaded onto a mixture of immediate release and polymer-coated, delayed-release resin particles.
Neos said Adzenys XR-ODT is patent-protected and is not a generic of amphetamine mixed salts XR capsules.
Neos Therapeutics president and CEO Vipin Garg said: "We believe that Adzenys XR-ODT will provide an important innovation for treatment in the ADHD market, and we intend to begin educating healthcare providers about our exciting new product immediately.
"Our full field force launch and product shipments will begin in the second quarter of 2016. We look forward to developing other treatment options for patients utilizing our technology platforms, both in ADHD and beyond."
ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood.
It is expected to affect 5% of children and 2.5% of adults in the US. Its symptoms include inattentiveness, hyperactivity and impulsiveness.
Neos said in 2014 alone, 63.1 million prescriptions for medications with ADHD labeling, and principally in extended-release formulations, were written in the US.
The company’s two lead product candidates are claimed to offer a plasma concentration-time profile which is consistent with once daily dosing in an orally disintegrating tablet that disintegrates in the mouth without water.