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Brexanolone · 4 trials · 5 indications
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of brexanolone, or any worsening of a pre-existing medical condition/adverse event with onset after the start of brexanolone and throughout the study.
Treatment-emergent adverse events will be assessed following administration of brexanolone.
The PANSS is a standardized, clinical interview that rates the presence and severity of psychosis. The PANSS yields a total average symptom score, based on 30 items rated from one to seven (range=30-210). Higher scores indicate more severe symptoms.
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. The items are selected based upon the core symptoms of mania. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe symptoms.
| Arm | Type | Description |
|---|---|---|
| Brexanolone | EXPERIMENTAL | Participants will receive a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. |
| Brexanaolone | EXPERIMENTAL | In this single-arm study, participants will be administered brexanolone as a continuous IV infusion over 20 hours (titrated up to 90mcg/kg/hour). |
| Open Label - Active Drug | EXPERIMENTAL | Brexanolone (zulresso) infusion arm. All patients enrolled will receive active treatment with brexanolone. |
| Name | Type | Description |
|---|---|---|
| Brexanolone | DRUG | Administered as IV infusion. |
Key Inclusion Criteria: 1. Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I Dis...
Brexanolone is an investigational small molecule being studied for several psychiatric conditions, including post-traumatic stress disorder (PTSD), postpartum depression, postpartum psychosis, and tinnitus. It is being developed by Supernus Pharmaceuticals, Inc. (SUPN). The drug is currently in Phase 1 clinical development for these indications.
Brexanolone is a small molecule that modulates the GABA-A receptor, a key inhibitory neurotransmitter system in the brain. By enhancing GABAergic signaling, it aims to restore neuronal balance and alleviate symptoms associated with conditions like PTSD, postpartum depression, and postpartum psychosis. This mechanism is being investigated in clinical trials.
Brexanolone is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol SUPN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for psychiatric and neurological conditions.
Brexanolone is currently in Phase 1 clinical development. While some trials listed for the drug are in earlier or later phases, the overall development stage is Phase 1. It is an investigational drug and has not been approved by the FDA for any indication.
Brexanolone has been studied in several clinical trials, including NCT03665038 for postpartum depression, NCT05223829 for PTSD and alcohol use disorder, NCT05314153 for postpartum psychosis, and NCT05645432 for tinnitus. These trials have been conducted in the United States with varying enrollment sizes.
Yes, Brexanolone is also known as Zulresso, as indicated by a clinical trial titled 'Effects Zulresso on Postpartum Psychosis' (NCT05314153). Zulresso is the brand name used in that study, while Brexanolone is the generic name of the drug.