Corium (NSDQ:CORI) announced today that the FDA set a Prescription Drug User Fee (PDUFA) target action date for its Adlarity system.
The FDA set the PDUFA target action date for Adlarity (donepezil transdermal system), a transdermal patch designed to treat dementia or Alzheimer’s disease, for March 11, 2022.
If approved, Boston-based Corium’s once-weekly Adlarity patch formulation would be the company’s second central nervous system (CNS) therapy product approved for the U.S. market within the past year following the March approval of its once-daily Azstarys oral capsule for treating ADHD symptoms.
According to a news release, Corium’s proprietary Corplex technology enables transdermal therapeutics that incorporate small molecule drugs, like Adlarity, to be delivered through the skin. The company designed the transdermal patch for a seven-day wear with consistent adhesion, eliminating the daily need for an oral medication that may cause difficulties in patients with significant memory problems brought on by dementia or Alzheimer’s.
The FDA previously approved donepezil as a once-daily tablet and as an orally disintegrating tablet for treating mild, moderate or severe forms of the disease. Adlarity’s slow and steady release of the therapeutic regularly delivers the drug through the skin with a design meant to avoid gastrointestinal tract absorption and associated side effects.
Corium is currently pursuing approval of two transdermal Adlarity doses capable of delivering 5mg or 10mg of donepezil daily. The company also has its Corplex platform under development for delivering drugs to treat patients with other CNS conditions, diseases in other therapeutic areas and consumer products beyond those for which it is currently used.
“Having Adlarity under consideration by the FDA reflects the significant R&D expertise at Corium. With Adlarity, Corium has leveraged our innovative Corplex technology to improve the most commonly used first-line treatment for patients with Alzheimer’s,” Corium president & CEO Perry J. Sternberg said in the release. “Our team at Corium is committed to addressing the unmet treatment needs for the Alzheimer’s community and others impacted by CNS diseases by developing innovative medicines. We look forward to the FDA’s decision early next year.”