KemPharm gets FDA nod for Azstarys

The Food and Drug Administration has given KemPharm the green light for Azstarys, a once-daily product for the treatment of attention deficit hyperactivity disorder in patients age six years and older.

Azstarys consists of serdexmethylphenidate,  or SDX, KemPharm’s prodrug of d-methylphenidate, or d-MPH, co-formulated with immediate-release d-MPH.

Corium, a portfolio company of Gurnet Point Capital, will lead the commercialization of Azstarys, as early as the second half of 2021.

“The FDA approval of the Azstarys NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD,” said Travis Mickle, president and CEO of KemPharm. “Today’s approval highlights both the value potential of SDX, our prodrug of d-MPH, and the ability of our LAT platform technology to develop new prodrugs of approved medications that improve one or more of the attributes of the parent drug. We look forward to continuing our support of Corium as they forge ahead with the commercial launch of Azstarys.”

“Today’s approval by the FDA is met with great excitement for this innovative new ADHD therapy and the potential it holds to meet the unmet needs of children, adolescents and adults,” said Perry Sternberg, CEO of Corium. “Our team is mobilized to put our commercial plans into action as the approval of the Azstarys NDA now enables us to finalize our preparations for commercial launch as early as the second half of this year.”