ADHD drug Adzenys addresses unmet need for patients, says GlobalData

The recent FDA approval of Neos Therapeutics’ Adzenys will provide patients who have problems swallowing pills with easy-to-administer drug options, according to an analyst with research and consulting firm GlobalData.

Adzenys, an orally disintegrating drug developed to treat attention deficit hyperactivity disorder (ADHD) which is intended for use in patients aged six years or older, uses the company’s proprietary Rapidly Disintegrating Ionic Masking (RDIM) technology.

Rachel Markwick, Ph.D., GlobalData’s Analyst covering Neurology and Ophthalmology, states that RDIM provides an extended release of amphetamine in the form of an orally disintegrating tablet, and includes taste-masking properties. As such, unmet needs within the ADHD market will be addressed for those who dislike swallowing tablets, or find it difficult, including both children and adults.

Markwick comments: “The technology used in Adzenys, which Neos plans to launch in Q2 of 2016 and make available in six dosage strengths, is also being utilized for another of the company’s late-stage ADHD candidate drugs, Cotempla XR-ODT (methylphenidate), which is likely to be launched in early 2018.

“GlobalData believes that while Adzenys and Cotempla will be helpful additions to the ADHD treatment space, Adzenys may initially encounter some skepticism, as Shire’s Vyvanse can already be sprinkled onto food.”

Adzenys uptake driven by its bioequivalence to Adderall XR

Despite this, the drug’s uptake will be driven by its demonstrated bioequivalence to Adderall XR, which is not common for reformulation products in ADHD that are typically compared to placebos.

Markwick continues: “Adzenys may be positioned early in the treatment paradigm as a comparable alternative to Adderall XR, one of the most highly prescribed drugs for ADHD in the US.

“By reformulating both amphetamine and methylphenidate, Neos will maximize its potential patient population. While the ultimate market share of both drugs may be limited by their niche roles in the ADHD arena, they offer clinical advantages that will help position Neos as an emerging player in a crowded treatment market.”