The Food and Drug Administration (FDA) Office of New Drugs (OND) notified Fabre-Kramer that it has granted appeal to the Formal Dispute Resolution (FDR) process, concluding that Travivo (gepirone ER) demonstrated substantial evidence of efficacy in the treatment of major depressive disorder (MDD).
John Jenkins, MD, OND Director, reviewed submitted materials, other reviews, meeting minutes, and decision memoranda prepared by the Agency, as well as other relevant materials. Dr. Jenkins also consulted with Lisa LaVange, PhD, who conducted a statistical review on the results of the Travivo Phase 3 program.
In 1998, Fabre-Kramer licensed the drug to Organon for further development and commercialization but was returned the licensing rights in 2005 after failure to obtain FDA approval and termination of its development. Following two additional studies, Fabre-Kramer resubmitted the NDA in 2007 but received a not approvable letter. Following a meeting for reconsideration, Fabre-Kramer submitted NDA amendments in February and December 2012 containing additional support. Finally in June 2015, the Director of OND indicated the need for input from PDAC prior to making a decision on the appeal.
Travivo was evaluated in more than 5,000 patients and has shown to be well-tolerated with a favorable safety profile. It is a full agonist at the pre-synaptic 5-HT1A auto-receptor and a partial agonist at the post-synaptic 5-HT1A receptor. This novel mechanism does not inhibit serotonin or noradrenaline reuptake and it does not inhibit monoamine oxidase. Gepirone ER demonstrates only weak affinity for adrenergic and histaminergic receptors. Based upon its unique mechanism of action at 5-HT1A, Travivo may be expected to increase libido and exert anxiolytic effects. Further, Travivo did not exhibit withdrawal effects, cardiovascular issues, seizure risk or weight gain in clinical trials.
The decision is still subject to possible internal review and Fabre-Kramer will meet with the FDA’s Center for Drug Evaluation and Research (CDER) Division of Psychiatry Products to discuss final details prior to the NDA resubmission. Once resubmitted, the FDA will have 6 months to review the amended NDA and make a decision.
For more information call (713) 977-1574 or visit FabreKramer.com.