Cingulate, a leading pharmaceutical company, has announced positive results from a Phase 3 study evaluating the efficacy and safety of its lead candidate, CTx-1301, for the treatment of attention deficit/hyperactivity disorder (ADHD).
Assessing Efficacy and Safety
The Phase 3 study focused on evaluating not only the efficacy and safety of CTx-1301 but also the onset and duration of its effects. The trial involved 21 adults with ADHD and took place in an adult laboratory classroom setting.
While the data from the trial did not achieve statistical significance on the primary efficacy endpoint, it did show a promising trend towards improvement in Permanent Product Measure of Performance scores when compared to placebo.
Significantly Improved Scores
One noteworthy finding was the significant improvement in Clinical Global Impression Scale scores with CTx-1301 compared to placebo, despite the study not being powered for statistical significance. This indicates that CTx-1301 has the potential to provide clinically beneficial effects.
Favorable Safety Profile
Cingulate reported that CTx-1301 demonstrated a favorable safety profile in comparison to placebo during the trial. Notably, none of the patients experienced insomnia during the randomized period. These positive safety findings further support the potential of CTx-1301 as a reliable treatment option for ADHD.
A Novel ADHD Medication
CTx-1301 is an investigational treatment that is being developed as a true once-daily stimulant medication for ADHD. The company aims to obtain approval from the U.S. Food and Drug Administration for this innovative therapeutic option.
Following the announcement of these positive results, Cingulate shares experienced a notable increase of 14%, reaching 66 cents in premarket trading.