- The Food and Drug Administration has foiled Sunovion Pharmaceuticals' short-term hopes for dasotraline, issuing a Complete Response Letter (CRL) for the attention-deficit hyperactivity disorder drug.
- The letter asked for further clinical data to be able to evaluate the drug's efficacy and tolerability in ADHD. Sunovion plans to meet with the FDA to discuss next steps.
- A dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), dasotraline is also in development for moderate-to-severe binge eating disorder in adults. Sunovion intends to submit an approval application for that indication by March 31, 2019.
The ADHD treatment market is a large, but busy one. Around 11% of children between 4 and 17 years have been diagnosed with ADHD, and up to 60% of these (over 4% of the U.S. population) will carry symptoms on into adulthood.
Though there are effective therapeutics out there, some have called for non-stimulant treatments. Sunovion's looking to provide an answer with dasotraline, but the FDA's rejection provides a new obstacle.
"While we are disappointed with the FDA's decision, we remain confident in the future of dasotraline," said Antony Loebel, chief medical officer at Sunovion's and head of global clinical development for Sumitomo Dainippon Pharma Group, in a statement.
Sunovion, which is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma, has a focus on psychiatric, neurological, and respiratory disorders. Its marketed respiratory products are largely around chronic obstructive pulmonary disease, after the company picked up three COPD products from Novartis and shed U.S. marketing rights to three approved asthma and allergy products, passing these on to Covis Pharma.
Sunovion's psychiatry pipeline is an expanding part of the company's attention. Latuda (lurasidone) is approved in the U.S. and Canada for the treatment of schizophrenia and of depression in bipolar I disorder, and in Europe and other parts of the world for the treatment of schizophrenia.
In addition to dasotraline in ADHD and moderate-to-severe binge eating disorder, Sunovion is developing SEP-363856 in schizophrenia and Parkinson's disease psychosis, and DSP-6745 in Parkinson's disease psychosis.
Correction: A previous version of this article misidentified when Sunovion plans to submit an application for dasotraline in moderate-to-severe binge eating disorder. A filing is planned by the end of Sunovion's 2018 fiscal year, which ends March 31, 2019.