Cingulate Inc. (NASDAQ: CING) shares weakened, as the drug company announced that it has received guidance from the Food and Drug Administration (FDA) on advancing its investigational asset CTx-2103 (buspirone) for the treatment of anxiety into clinical development.
Said CEO Shane J. Schaffer. “This is a positive step that may allow CTx-2103 to seek and win approval under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway.”
Anxiety disorders are the most common mental health concern in the U.S. An estimated 31% of U.S. adults experience an anxiety disorder at some time in their lives. People may live with anxiety for years before they are diagnosed or treated.
CTx-2103, which contains the active pharmaceutical ingredient buspirone hydrochloride, is a non-benzodiazepine medication that does not carry the risk of withdrawal or dependency. However, due to its short half-life, buspirone is prescribed to be taken several times a day for management of anxiety, which can be challenging for patients and may lead to sub-optimal treatment outcomes.
CTx-2103 is a once-daily, multi-dose tablet that provides three precisely timed doses of buspirone versus one immediate release dose. The Company believes its trimodal tablet will offer clear differentiation and compelling advantages over currently available treatment options.
CING shares slid 41 cents, or 6.5%, to $5.86.