Exxua(Gepirone ER)

Psychiatry· 571 cited findings· 1 source document

Company: FABRE KRAMER

What the regulatory reviews say

Exxua (Gepirone ER) is a drug reviewed under NDA 021164 as a Standard application. Two studies demonstrated effectiveness for gepirone ER in adults. However, a long-term efficacy study (28709) failed to demonstrate efficacy, and pediatric studies (134019 and 134020) did not demonstrate efficacy. The primary endpoint for studies 134001 and FKGBE007 was the change from baseline to 8 weeks in HAMD-17 total score.

Applicant's analysis of relapse rates showed 23.0% for gepirone ER versus 34.7% for placebo, with a CMH p-Value of 0.0244. Reviewer's analyses showed varying CMH p-Values depending on grouping methods, ranging from 0.0971 to 0.3302. Notable adverse reactions include high rates of dizziness, headache, and nausea, and a clinically significant risk of QT interval prolongation. Four deaths occurred in adult subjects receiving gepirone ER, with two attributed to suicide. The incidence of serious adverse events (SAEs) in the gepirone ER and IR combined group was 2% to 3%, compared to 0.9% to 1% in the placebo group.

Key figures — cited to the source page

Number of studies demonstrating effectiveness for gepirone ER in adults	2	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.18
Relapse rate (Applicant's analysis) vs Placebo	23.0% vs 34.7%	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.74
CMH p-Value (Applicant's analysis)	0.0244	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.74
Adverse reactions associated with gepirone ER	high rates of dizziness, headache, and nausea	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.20
QT interval prolongation risk	clinically significant	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.20
Deaths in adult subjects receiving gepirone ER	4	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.106
Deaths due to suicide in gepirone ER arm	2	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.106
Incidence of SAEs in gepirone ER and IR combined group	2% to 3%	FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023), p.107

Source documents

FABRE KRAMER — Exxua FDA Review (NDA021164, ORIG 1, 2023) (2023)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.