The study measured progress using the Hamilton Anxiety Rating Scale at the 12-week mark, where patients showed statistically significant improvements compared to those receiving a placebo. The company noted that the orally disintegrating tablet remained well-tolerated throughout the testing period, maintaining a safety profile consistent with earlier trials on major depressive disorder and anxiety.

Chief Executive Rob Barrow confirmed that the firm is now preparing for a pre-NDA meeting with the FDA scheduled for the fourth quarter. With these results in hand, Definium Therapeutics plans to move forward with a formal new drug application filing in the first half of next year.