Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date

Submission of EXXUA (gepirone HCl), a novel targeted single serotonin receptor agonist for treatment of Major Depressive Disorder receives PDUFA action date of June 23, 2023.

HOUSTON, Jan. 24, 2023 (View press release on PRNewswire.com)

Fabre-Kramer Pharmaceuticals, a leading developer of novel small molecule medications to address unmet needs in the treatment of psychiatric and neurological disorders, announced today it received on January 20, 2023 acknowledgement and acceptance of its December 23, 2022 NDA Amendment for EXXUA (gepirone hydrochloride) extended release tablets for the treatment of Major Depressive Disorder (MDD). The FDA designated the filing as a Complete Response Class 2 resubmission of NDA 021164 and assigned a PDUFA action date of June 23, 2023.

EXXUA is a novel serotonin (5HT) single receptor (1A) agonist that has demonstrated effectiveness and a favorable safety profile in clinical trials as monotherapy for major depressive disorder.

“We are pleased with FDA’s acceptance of EXXUA for regulatory review for the treatment of MDD and look forward to working with the Agency on the review” stated Stephen Kramer, MD, CEO of Fabre-Kramer. “Prescribers and patients can greatly benefit from truly novel treatments for MDD that employ new mechanisms and address important unmet needs.”