FDA Approves ADHD Co-Formulated Treatment

The US Food and Drug Administration (FDA) has approved serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) (AZSTARYS) capsules for the treatment of attention deficit/hyperactivity disorder (ADHD).

The approval, awarded for KemPharm, is for the treatment to be used as a once-daily oral capsule in patients at least 6 years old, co-formulated in a way that results in the immediate release of d-MPH.

The Drug

The treatment was developed to meet some of the unmet needs of ADHD patients with the most widely-prescribed methylphenidate ADHD, including earlier onset of action and longer duration of therapy. The treatment is also designed to avoid unnecessary spikes in d-MPH concentrations that are commonly associated with adverse events.

The Future

The treatment is expected to be available in the US during the third quarter 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,” Travis C. Mickle, PhD, President and CEO of KemPharm, said in a statement. “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.”

In December, representatives from KenPharm met with the FDA in a late-cycle communication meeting to discuss the drug, formerly called KP415. In the meeting, the agency did not raise any substantive issues related to the safety and efficacy of the treatment.