The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for Exxua (gepirone hydrochloride extended-release [ER]) for the treatment of major depressive disorder (MDD).

Exxua (formerly known as Travivo) is a novel oral serotonin (5HT) 1A receptor agonist with a long regulatory history. Fabre-Kramer Pharmaceuticals regained the licensing rights for gepirone ER in 2005 after Organon failed twice to obtain FDA approval. In March 2016, Fabre-Kramer successfully appealed to the Formal Dispute Resolution process to overturn a deficiency impeding approval.

The director of Office of New Drugs (OND) at the time, John Jenkins, MD, said “I conclude that Fabre-Kramer has provided data to support a finding of substantial evidence of effectiveness for gepirone in the short-term treatment of MDD.”

The efficacy and safety of gepirone ER has been studied in more than 5000 patients and was found to be effective with a favorable safety profile. According to adverse event data collected in numerous Travivo trials, the treatment was not associated with sexual dysfunction in depressed patients.

Stephen Kramer, MD, CEO of Fabre-Kramer said, “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.”

This latest application is filed as a Complete Response Class 2 resubmission of NDA 021164. The application has been assigned a Prescription Drug User Fee Act target date of June 23, 2023.

References

  1. Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date. News Release. Fabre-Kramer. January 4, 2023. https://www.prnewswire.com/news-releases/fabre-kramer-pharmaceuticals-announces-fda-acceptance-of-nda-resubmission-as-complete-response-and-assignment-of-pdufa-regulatory-action-date-301729484.html.  
  2. Fabre-Kramer Submits NDA Amendment for EXXUA™ for Treatment of Major Depressive Disorder. News Release. Fabre-Kramer. January 24, 2023. https://www.prnewswire.com/news-releases/fabre-kramer-submits-nda-amendment-for-exxua-for-treatment-of-major-depressive-disorder-301712935.html.
  3. FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder. News Release. Fabre-Kramer. May 17, 2016. https://www.prnewswire.com/news-releases/fda-rules-favorably-on-efficacy-of-travivo-gepirone-er-for-treatment-of-major-depressive-disorder-300237987.html.