Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.
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.