Gepirone Extended-Release: First Approval

被引：11
作者：
Keam, Susan J. [1 ]
机构：
[1] Springer Nat, Private Bag 65901, Auckland 0754, New Zealand
来源：
DRUGS | 2023年 / 83卷 / 18期
基金：
英国科研创新办公室;
关键词：
DISORDER; ER; PHARMACOKINETICS; OUTPATIENTS;
D O I：
10.1007/s40265-023-01975-5
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Gepirone HCL extended-release (gepirone ER; EXXUA (TM)), an oral, selective serotonin (5HT)1A receptor agonist formulated for once-daily administration, has been developed by Fabre-Kramer Pharmaceuticals, Inc. for the treatment of psychiatric disorders, including major depressive disorder (MDD). In September 2023, gepirone ER was approved in the USA for the treatment of adults with MDD. This article summarizes the milestones in the development of gepirone ER leading to this first approval for the treatment of adults with MDD.
引用
收藏
页码：1723 / 1728
页数：6
相关论文
共 20 条
  • [1] [Anonymous], 2023, Depressive Disorder (Depression)
  • [2] [Anonymous], 2019, Apa clinical practice guideline for the treatment of depression across three age cohorts
  • [3] Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: A double-blind, randomized, placebo-controlled, parallel-group study
    Bielski, Robert J.
    Cunningham, Lynn
    Horrigan, Joseph P.
    Londborg, Peter D.
    Smith, Ward T.
    Weiss, Kenneth
    [J]. JOURNAL OF CLINICAL PSYCHIATRY, 2008, 69 (04) : 571 - 577
  • [4] INVOLVEMENT OF 5-HT1A RECEPTORS IN THE ANTIDEPRESSANT-LIKE ACTIVITY OF GEPIRONE IN THE FORCED SWIMMING TEST IN RATS
    CHOJNACKAWOJCIK, E
    TATARCZYNSKA, E
    GOLEMBIOWSKA, K
    PRZEGALINSKI, E
    [J]. NEUROPHARMACOLOGY, 1991, 30 (07) : 711 - 717
  • [5] Pharmacokinetics of gepirone in subjects with normal renal function and in patients with chronic renal dysfunction
    Dogterom, P
    Huisman, JAM
    Gellert, R
    Verhagen, A
    [J]. CLINICAL DRUG INVESTIGATION, 2002, 22 (08) : 513 - 522
  • [6] Effects of food on the bioavailability of gepirone from extended-release tablets in humans: Results of two open-label crossover studies
    Fabre, LF
    Timmer, CJ
    [J]. CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL, 2003, 64 (08): : 580 - 598
  • [7] The Effect of Gepirone-ER in the Treatment of Sexual Dysfunction in Depressed Men
    Fabre, Louis F.
    Clayton, Anita H.
    Smith, Louis C.
    Goldstein, Irwin
    Derogatis, Leonard R.
    [J]. JOURNAL OF SEXUAL MEDICINE, 2012, 9 (03) : 821 - 829
  • [8] Gepirone-ER Treatment of Hypoactive Sexual Desire Disorder (HSDD) Associated with Depression in Women
    Fabre, Louis F.
    Brown, Candace S.
    Smith, Louis C.
    DeRogatis, Leonard R.
    [J]. JOURNAL OF SEXUAL MEDICINE, 2011, 8 (05) : 1411 - 1419
  • [9] Fabre-Kramer Pharmaceuticals Inc, 2023, GEPIRONE ER US PRESC
  • [10] Fabre-Kramer Pharmaceuticals Inc, 2015, FABRE KRAMER LOOKS F
12