Fabre-Kramer Submits NDA Amendment for EXXUA™ for Treatment of Major Depressive Disorder

New Class of Antidepressant's Novel Mechanism Uniquely and Directly Addresses Important Unmet Needs

HOUSTON, Jan. 4, 2023 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant EXXUA™ (gepirone ER) for treatment of Major Depressive Disorder (MDD).

FDA has previously confirmed EXXUA's efficacy in the treatment of MDD and stated that no relevant safety issues preclude an approval recommendation.

Studied in over 5,000 patients, EXXUA's unique mechanism of targeted single serotonin (5HT) 1a receptor agonism relieves depressive symptoms without significant side effects. EXXUA does not cause sexual dysfunction in depressed patients, a common side effect among most available antidepressants. In late 2021 FDA imposed safety labeling  warning of serious risk of sexual dysfunction on all SSRI and SNRI products. EXXUA was shown superior in sexual functioning to SSRIs in several studies and to not cause any meaningful weight gain.

Fabre-Kramer CEO Stephen Kramer, M.D. said "The submission of this Amendment is the culmination of years of dedicated effort by our team and we look forward to working with FDA on its review. EXXUA, once approved, will be the first targeted single serotonin receptor antidepressant, a truly new class, with the potential to benefit millions of MDD patients. There is value in providing prescribers and patients with a wide range of effective options for use in clinical practice."

Anita H. Clayton, MD, Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, a renowned clinician and researcher of sexual dysfunction issues in MDD treatment commented "Prevalence of Sexual Dysfunction is a major issue in treatment of MDD. A treatment option (especially working through serotonin systems) for MDD patients who cannot tolerate or don't want to risk experiencing sexual side effects of available treatments has been needed for a long time."

Stephen A. Stahl, MD, PhD., Professor of Psychiatry, University of California, founder of the Neuroscience Education Institute and a preeminent psychopharmacologist said "EXXUA is the first truly selective agonist of the serotonin 1A receptor that mediates mood and has been consistently linked to mood disorders and suicide risk in human PET (positron emission tomography) studies. By targeting the 1A receptor more selectively than either the SSRI/SNRIs or buspirone, EXXUA avoids negative side effects including sexual dysfunction and weight gain."

Major depressive disorder (MDD) is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings of worthlessness, low energy, and other emotional and physical symptoms, and impairment of important functioning. In severe cases, MDD can result in suicide. According to the US Department of Health and Human Services, an estimated 21 million US adults experience MDD each year. Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with available first-line treatment, highlighting the need for additional therapies with new mechanisms of action.

EXXUA is a novel oral serotonin (5HT) 1A receptor agonist being developed for the treatment of MDD and other psychiatric disorders.

Fabre-Kramer is committed to developing and bringing to market advanced new medications to help physicians treat their patients' unmet medical needs in the therapeutic areas of psychiatry and neurology. The Company focuses on compounds to license-in, develop for global registration, and license-out to commercial partners. The Company looks forward to discussions with potential partners to bring EXXUA to market once approved.

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SOURCE Fabre-Kramer Pharmaceuticals, Inc.