Corium (NSDQ:CORI) announced today that it received FDA approval for its once-daily Azstarys oral capsule for treating ADHD symptoms.
Boston-based Corium touts its Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) drug as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients aged six years and older, according to a news release.
Azstarys consists of 30% immediate-release d-MPH and 70% extended-release novel SDX, a prodrug of d-MPH. After it is absorbed through the gastrointestinal tract, SDX is converted into d-MPH and designed to gradually release the therapeutic throughout the day, delivering rapid symptom control along with treatment for an extended duration.
Corium says the aim of Aztarys is to address unmet needs in the market, including early onset of action and long duration of therapy combined into steady symptom control in just one capsule.
The drug was evaluated in a study of 150 children aged six to 12 years old, which observed significant improvements in children treated with Azstarys compared to those receiving a placebo, although adverse events did occur more frequently in the treatment group.
“The FDA approval of Azstarys means Corium is one step closer to bringing this innovative therapy to market and providing patients with ADHD and their clinicians a new option for rapid and extended symptom control via the dual action of d-MPH and the novel d-MPH prodrug SDX,” Corium president & CEO Perry J. Sternberg said in the release. “The team at Corium is energized to leverage their deep ADHD and commercialization expertise to launch and market Azstarys, which is an important milestone for Corium and its focus on [central nervous system] therapies.”