Researchers are prepared a phase 3 trial testing the treatment in adults with ADHD.
New research presented on a poster during the American Professional Society of ADHD and Related Disorders (APSARD) 2021 Annual Conference shows the value in CTx-1301 (dexmethylphenidate) as a beneficial treatment under fasted conditions for adult patients with attention deficit/hyperactivity disorder (ADHD).
In the randomized, single-dose, four-sequence, four-period, crossover study, a team of researchers compared the drug with Focalin XR in 45 adults with ADHD.
The researchers found the study drug exhibited similar systemic d-MPH exposure to the comparison drug for up to 8 hours following administration. Plasma concentrations at 15-16 hours for CTx-1301 were also similar to the comparison drug at 12 hours.
CTx-1301 demonstrated a statistically significant higher concentration (P <0.05) compared to Focalin XR from 9-16 hours in both low and high doses, while CTx-1301 is expected to have a similar onset of action as the comparison drug (30 minutes).
Overall, the CTx-1301 tablets showed a trimodal pharmacokinetic profile with fast onset, entire active-day duration. This shows the drug has the potential to minimize crash and rebound, while eliminating the need for booster doses.
In an interview with HCPLive®, Matthew Brams, MD, Chief Medical Officer of Cingulate Therapeutics, and Shane Schaffer, PharmD, CEO of Cingulate, explained the results and what the plans are for a phase 3 trial.