Cingulate Inc. 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. 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. In September 2022, Cingulate completed a formulation study in which the pharmacokinetics of CTx-2103 were evaluated. Additionally, scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which was correlated with the pharmacokinetic data to establish the release profile of the CTx-2103 formulation.

Based on the data from this study, CTx-2103 provides three timed releases of buspirone, as it was designed to do. CTx-2103 is a novel, trimodal, extended-release tablet of buspirone that incorporates Cingulate?s proprietary PTR drug delivery platform. CTx-2103 is being studied for the treatment of anxiety and/or anxiety-related disorders.

Buspirone, an azapirone derivative and a 5-HT1A partial agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized anxiety disorder. Buspirone may exhibit a decreased side-effect profile compared to other anxiolytic treatments. Unlike benzodiazepines and barbiturates, there is no associated risk of physical dependence or withdrawal with buspirone use due to the lack of effects on gamma-aminobutyric acid receptors.