FDA declines to approve Cingulate’s ADHD treatment over manufacturing issues

June 2 (Reuters) – Drug developer Cingulate said on Tuesday the U.S. Food and Drug Administration declined to approve its drug to treat attention deficit hyperactivity disorder, citing manufacturing-related concerns.

In its complete response letter, the FDA did not flag any concerns about the drug’s safety or effectiveness, Cingulate said.

The drug, CTx-1301, is designed to target the neurodevelopmental disorder, which can cause persistent inattention, hyperactivity and impulsive behavior, often affecting children and continuing into adulthood. 

The once-daily tablet form of dexmethylphenidate, an ingredient used in several approved ADHD drugs, aims to improve attention and curb impulsivity.

Cingulate said it plans to promptly submit the requested information to the FDA.

“Our immediate priority is to complete the CMC (chemistry, manufacturing and controls) (and) we believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission,” said Cingulate CEO Shane Schaffer.

The company added it has nearly $30 million in cash, which it expects will support the resubmission process and operations into 2027.

Dexmethylphenidate belongs to a class of stimulant drugs that work by increasing the activity of dopamine and norepinephrine, brain chemicals involved in attention and behavior.

If approved, the drug would enter a crowded ADHD market that includes treatments such as Takeda Pharmaceutical’s Vyvanse and Johnson & Johnson’s Concerta.

A similar drug, Novartis’ Focalin XR, uses the same active ingredient, dexmethylphenidate, but with only a two-stage release. 

Cingulate is aiming to address the midday wear-off seen with existing treatments and potentially improve adherence.

(Reporting by Kunal Das and Siddhi Mahatole in Bengaluru; Editing by Vijay Kishore and Diti Pujara)