FDA rejects dasotraline NDA for ADHD, calling for more data

3 September 2018

The US Food and Drug Administration has issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD), under development at Sunovion Pharmaceuticals, a US subsidiary of Japanese pharma company Sumitomo Dainippon Pharma (TYO: 4506).

Announced on Friday after Japanese stock exchanges had closed, the news sent Sumitomo Dainippon’s shares tumbling 9.39% to 2,143 yen in Monday (September 3) trading.

Upon completion of its review, the FDA determined that it cannot approve the dasotraline NDA for the treatment of ADHD in its current form. The agency indicated that additional clinical data are needed to further evaluate the efficacy and tolerability of dasotraline for the treatment of ADHD. Sunovion plans to meet with the FDA to discuss their comments and determine next steps.

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