Exxua (gepirone ER) / Fabre-Kramer - LARVOL DELTA

Gepirone: A New Extended-Release Oral Selective Serotonin Receptor Agonist for Major Depressive Disorder. (PubMed, J Pharm Technol) - "Gepirone is expected to receive greater clinical relevance and recommendations when compared to other azapirone medications (buspirone) within practice guidelines. Gepirone could be considered as either an alternative option for patients failing first-line therapies or for initial use to avoid unwanted side effects of other therapy options in the treatment of adult patients with major depressive disorder."

Journal • Review • CNS Disorders • Depression • Fatigue • Insomnia • Major Depressive Disorder • Mood Disorders • Pain • Psychiatry • Sleep Disorder

Effects of Gepirone-ER on Sexual Function in Patients With Major Depressive Disorder. (PubMed, J Clin Psychiatry) - " Gepirone-ER was not associated with sexual dysfunction in patients with MDD. Rates of sexual side effects and treatment-emergent sexual dysfunction with gepirone-ER were comparable to those reported for placebo and lower than sexual side effects reported for active treatment with SSRIs."

Clinical • Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Sexual Disorders

MDD, antidepressants and sexual dysfunction (ECNP 2024) - "Selective serotonin reuptake inhibitors (SSRIs) and venlafaxine have prevalence rates of 70-80%; tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and escitalopram demonstrate rates of 40-45%; antidepressants with unique mechanisms of action like bupropion, mirtazapine, vortioxetine, vilazodone, gepirone-ER and agomelatine have rates similar to placebo at <10% in double-blind, open-label, cross-sectional and retrospective studies. Individualizing interventions based on patient preferences are needed for appropriate dosing, effective management of MDD, patient satisfaction, quality of life and treatment adherence. Discussion will consider factors impacting SD and a broad range of interventions."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

CA10 – MDD, antidepressants and sexual dysfunction (ECNP 2024) - "Selective serotonin reuptake inhibitors (SSRIs) and venlafaxine have prevalence rates of 70-80%; tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and escitalopram demonstrate rates of 40-45%; antidepressants with unique mechanisms of action like bupropion, mirtazapine, vortioxetine, vilazodone, gepirone-ER and agomelatine have rates similar to placebo at <10% in double-blind, open-label, cross-sectional and retrospective studies. Individualizing interventions based on patient preferences are needed for appropriate dosing, effective management of MDD, patient satisfaction, quality of life and treatment adherence. Discussion will consider factors impacting SD and a broad range of interventions."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Review of Data on Gepirone Efficacy and Tolerability in the Treatment of Major Depressive Disorder and Generalized Anxiety Disorder (ISBD 2024) - " Gepirone ER had been associated with favorable results in five clinical trials focused on MDD, according to the evolution of the main outcome, and an improvement in sexual function was also reported in another study that compared gepirone ER with fluoxetine and placebo, and in two post-hoc analyses. Gepirone ER recommendation for MDD is supported by multiple clinical trials, but their duration was short, therefore longer-term studies are needed. Also, there is promising data for gepirone ER in patients with GAD."

Clinical • Review • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Mood Disorders • Psychiatry

The Black Book of Psychotropic Dosing and Monitoring. (PubMed, Psychopharmacol Bull) - "The combination of dextromethorphan 45 mg twice per day and bupropion SR 105 mg twice daily appears to be more effective than an equivalent dose of bupropion alone both in speeding up antidepressant response and achieving remission...The phase III program for Auvelity, showed that the drug was well tolerated with the most common side effects being dizziness, headache, and dry mouth.86 Another novel antidepressant agent approved in 2023 is zuranolone (Zurzuvae)...Zuranolone's, as does brexanolone, is thought to act primarily as allosteric modulator of the GABA-a receptors...Gepirone is not exactly a new or novel antidepressant and originally sought approval in the US about 20 years ago.88 There had been two positive studies of gepirone during the original NDA application but also a number of failed, negative, or non-informative studies as well...Second generation antipsychotics (SGAs) continue to be the only class of agents [other than esketamine (Spravato)] approved..."

Journal • Review • Addiction (Opioid and Alcohol) • Alzheimer's Disease • Anesthesia • CNS Disorders • Constipation • Depression • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Insomnia • Major Depressive Disorder • Mental Retardation • Mood Disorders • Pain • Postpartum Depression • Post-traumatic Stress Disorder • Psychiatry • Schizophrenia • Sleep Disorder • Xerostomia

Gepirone (Exxua) for depression. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Gepirone-the latest antidepressant on market state-of-the-art or run-of-the-mill? (PubMed, Asian J Psychiatr) - "It belongs to azapirones group of psychotropics that is in popular use in Japan and China. Here, author wraps up current knowledge on gepirone contrasted with the older and cheaper anxiolytic buspirone."

Journal

Drugs for depressionr. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Gepirone Extended-Release: First Approval. (PubMed, Drugs) - "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."

Journal • Review • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

"شركة فابري كرامير الدوائية أكملت تسليم هيئة الغذاء والدواء @US_FDA طلب اعتماد الدواء التجريبي 💊EXXUA (gepirone HCl)إكسوا المطور لعلاج الإكتئابMDD 🗓تم تحديد موعد ٢٣ يونيو لمناقشة البيانات واقرار الاعتماد أو الرفض https://t.co/qPf1yP6zl9 5️⃣" (@YAYshamsaldeen)

Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date (PRNewswire) - "Fabre-Kramer Pharmaceuticals...announced today it received on January 20, 2023 acknowledgement and acceptance of its December 23, 2022 NDA Amendment for EXXUA (gepirone hydrochloride) extended release tablets for the treatment of Major Depressive Disorder (MDD). The FDA designated the filing as a Complete Response Class 2 resubmission of NDA 021164 and assigned a PDUFA action date of June 23, 2023."

PDUFA date • CNS Disorders • Depression • Major Depressive Disorder

Intra- and extra-articular proximal tibia malunion. (PubMed, Orthop Traumatol Surg Res) - "Malunion results from reduction defect and/or secondary displacement in tibial plateau fracture (A2, A3, B, C on the AO classification), but also from previous epiphysiodesis or osteotomy (valgization or varization)...Results in total replacement are poorer than for primary implants in osteoarthritis of the knee, with much more frequent complications. LEVEL OF EVIDENCE: V, expert opinion."

Journal • Review • CNS Disorders • Depression • Erectile Dysfunction • Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology

"More accurate correction using "patient-specific" cutting guides in opening wedge distal femur varization osteotomies. (PubMed, Int Orthop) - "Our results suggest that the use of PSI in DFVO improves the accuracy of correction in both the coronal and sagittal planes compared to conventional techniques."

Clinical • Journal • Immunology • Osteoarthritis • Pain

Fixation of the short global tissue-sparing hip stem. (PubMed, Bone Joint J) - "A substantially different and more extensive initial migration pattern was seen for the GTS stem compared to the Taperloc stem. Although implant stabilization was achieved, excellent long-term survival similar to that of the Taperloc stem should not be inferred. Especially in the absence of clinically proven relevant improvement, widespread usage should be postponed until long-term safety has been established. Cite this article: Bone Joint J 2020;102-B(6):699-708."

Clinical • Journal • Immunology • Orthopedics • Osteoarthritis • Pain • Rheumatology

Linear influence of distal femur osteotomy on the Q-angle: one degree of varization alters the Q-angle by one degree. (PubMed, Knee Surg Sports Traumatol Arthrosc) - "Distal femur varization osteotomy has a linear effect on the Q-angle with a change of 1° per 1° of varization. The difference in TT-TG distance was mainly due to an unintentional rotational component implemented during surgery."

Journal

Sexual Performance Anxiety. (PubMed, Sex Med Rev) - "SPA causes or maintains most common sexual dysfunction. No treatments are well proven, although cognitive behavior therapy, mindfulness meditation training, and serotonergic anxiolytics (buspirone, trazodone, gepirone) have potential, and phosphodiesterase type 5 inhibitors are effective for psychogenic ED and premature ejaculation. Several phytotherapies also appear to have potential. Pyke RE. Sexual Performance Anxiety. J Sex Med 2019; XX:XXX-XXX."

Journal • Review

Gepirone hydrochloride: a novel antidepressant with 5-HT1A agonistic properties. (PubMed, Drugs Today (Barc)) - "In addition to its better efficacy, gepirone is well tolerated and the major adverse effects observed have been nausea, dizziness and lightheadedness. Evidence from preclinical and clinical studies revealed that gepirone could be a breakthrough therapeutic agent in the treatment of anxiety and MDD."

Journal