FDA to Consider Depression Drug Approval Again After Multiple Rejections

FDA withdraws warning letter after resolution
FDA withdraws warning letter after resolution

Fabre-Kramer announced that the Food and Drug Administration (FDA)'s  Psychopharmacologic Drugs Advisory Committee (PDAC) has finished its review of gepirone ER for the treatment of major depressive disorder (MDD) and now awaits the FDA's decision on whether the drug should be approved. 

Gepirone ER 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.

Data from two studies demonstrated substantial evidence of efficacy for gepirone ER and the advisory committee also supported the product's safety. The current standing members of PDAC voted favorably in regards to the benefit risk of gepirone ER for treating MDD. Some members, however, suggested the possible need for a third positive study to counter the negative studies and to further support the drug's efficacy. 

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The studies showed gepirone ER effectively treated MDD without causing the sexual dysfunction often associated with SSRI and SNRI drug classes. Based upon its unique mechanism of action at 5-HT1A, gepirone ER may be expected to increase libido and exert anxiolytic effects. Further, gepirone ER did not exhibit withdrawal effects, cardiovascular issues, seizure risk or weight gain. 

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. 

For more information visit Fabrekramer.com
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