Brexanolone: First Global Approval
Brexanolone (ZULRESSO™) is an intravenously administered, small molecule, neuroactive steroid GABA A receptor positive allosteric modulator that was developed by Sage Therapeutics under license to the University of California for the treatment of postpartum depression (PPD). The formulation is a mix...
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| Veröffentlicht in: | Drugs (New York, N.Y.) N.Y.), 2019-05, Vol.79 (7), p.779-783 |
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| container_title | Drugs (New York, N.Y.) |
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| creator | Scott, Lesley J. |
| description | Brexanolone (ZULRESSO™) is an intravenously administered, small molecule, neuroactive steroid GABA
A
receptor positive allosteric modulator that was developed by Sage Therapeutics under license to the University of California for the treatment of postpartum depression (PPD). The formulation is a mixture of allopregnanolone, an endogenous inhibitory pregnane neurosteroid, and sulfobutylether-beta-cyclodextrin (a solubilizing agent). In mid-March 2019 brexanolone received its first global approval in the USA for the treatment of PPD in adult women. This article summarizes the milestones in the development of brexanolone leading to its first approval for the treatment of adult women with PPD. |
| doi_str_mv | 10.1007/s40265-019-01121-0 |
| format | Article |
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A
receptor positive allosteric modulator that was developed by Sage Therapeutics under license to the University of California for the treatment of postpartum depression (PPD). The formulation is a mixture of allopregnanolone, an endogenous inhibitory pregnane neurosteroid, and sulfobutylether-beta-cyclodextrin (a solubilizing agent). In mid-March 2019 brexanolone received its first global approval in the USA for the treatment of PPD in adult women. This article summarizes the milestones in the development of brexanolone leading to its first approval for the treatment of adult women with PPD.</description><identifier>ISSN: 0012-6667</identifier><identifier>ISSN: 1179-1950</identifier><identifier>EISSN: 1179-1950</identifier><identifier>DOI: 10.1007/s40265-019-01121-0</identifier><identifier>PMID: 31006078</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>AdisInsight Report ; Administration, Intravenous - methods ; Adolescent ; Adult ; Adults ; Allosteric properties ; Allosteric Regulation - drug effects ; Anesthesia ; beta-Cyclodextrins - administration & dosage ; beta-Cyclodextrins - adverse effects ; beta-Cyclodextrins - pharmacokinetics ; beta-Cyclodextrins - pharmacology ; beta-Cyclodextrins - therapeutic use ; Breastfeeding & lactation ; Cyclodextrins ; Depression, Postpartum - drug therapy ; Drug Approval ; Drug Combinations ; Drug dosages ; Drug therapy ; Drug Therapy, Combination - methods ; FDA approval ; Female ; Humans ; Internal Medicine ; Medicine ; Medicine & Public Health ; Mental depression ; Metabolites ; Middle Aged ; Pharmacology/Toxicology ; Pharmacotherapy ; Postpartum depression ; Pregnanolone ; Pregnanolone - administration & dosage ; Pregnanolone - adverse effects ; Pregnanolone - pharmacokinetics ; Pregnanolone - pharmacology ; Pregnanolone - therapeutic use ; Receptors, Steroid - metabolism ; Steroids ; Treatment Outcome ; United States ; United States Food and Drug Administration ; β-Cyclodextrin ; γ-Aminobutyric acid A receptors</subject><ispartof>Drugs (New York, N.Y.), 2019-05, Vol.79 (7), p.779-783</ispartof><rights>Springer Nature Switzerland AG 2019</rights><rights>Copyright Springer Nature B.V. May 2019</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-4a277e178f4510f6c878d9b144076af9d511acfd00d36609184c21a3a922d5483</citedby><cites>FETCH-LOGICAL-c375t-4a277e178f4510f6c878d9b144076af9d511acfd00d36609184c21a3a922d5483</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40265-019-01121-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40265-019-01121-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51298</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31006078$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Scott, Lesley J.</creatorcontrib><title>Brexanolone: First Global Approval</title><title>Drugs (New York, N.Y.)</title><addtitle>Drugs</addtitle><addtitle>Drugs</addtitle><description>Brexanolone (ZULRESSO™) is an intravenously administered, small molecule, neuroactive steroid GABA
A
receptor positive allosteric modulator that was developed by Sage Therapeutics under license to the University of California for the treatment of postpartum depression (PPD). The formulation is a mixture of allopregnanolone, an endogenous inhibitory pregnane neurosteroid, and sulfobutylether-beta-cyclodextrin (a solubilizing agent). In mid-March 2019 brexanolone received its first global approval in the USA for the treatment of PPD in adult women. This article summarizes the milestones in the development of brexanolone leading to its first approval for the treatment of adult women with PPD.</description><subject>AdisInsight Report</subject><subject>Administration, Intravenous - methods</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Adults</subject><subject>Allosteric properties</subject><subject>Allosteric Regulation - drug effects</subject><subject>Anesthesia</subject><subject>beta-Cyclodextrins - administration & dosage</subject><subject>beta-Cyclodextrins - adverse effects</subject><subject>beta-Cyclodextrins - pharmacokinetics</subject><subject>beta-Cyclodextrins - pharmacology</subject><subject>beta-Cyclodextrins - therapeutic use</subject><subject>Breastfeeding & lactation</subject><subject>Cyclodextrins</subject><subject>Depression, Postpartum - drug therapy</subject><subject>Drug Approval</subject><subject>Drug Combinations</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination - methods</subject><subject>FDA approval</subject><subject>Female</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mental depression</subject><subject>Metabolites</subject><subject>Middle Aged</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Postpartum depression</subject><subject>Pregnanolone</subject><subject>Pregnanolone - administration & dosage</subject><subject>Pregnanolone - adverse effects</subject><subject>Pregnanolone - pharmacokinetics</subject><subject>Pregnanolone - pharmacology</subject><subject>Pregnanolone - therapeutic use</subject><subject>Receptors, Steroid - metabolism</subject><subject>Steroids</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><subject>β-Cyclodextrin</subject><subject>γ-Aminobutyric acid A receptors</subject><issn>0012-6667</issn><issn>1179-1950</issn><issn>1179-1950</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kEFLwzAYhoMobk7_gAcZevES_b60SRpvc7gpDLzoOaRtKhtdM5NV9N-b2qngwUMIIc_7fh8PIacIVwggr0MKTHAKqOJBhhT2yBBRKoqKwz4ZAiCjQgg5IEchrLqn4uqQDJKYFyCzITm_9fbdNK52jb0Zz5Y-bMfz2uWmHk82G-_eTH1MDipTB3uyu0fkeXb3NL2ni8f5w3SyoEUi-ZamhklpUWZVyhEqUWQyK1WOaQpSmEqVHNEUVQlQJkKAwiwtGJrEKMZKnmbJiFz2vXHsa2vDVq-XobB1bRrr2qAZQyZRyAQievEHXbnWN3G7SPEMlFCqo1hPFd6F4G2lN365Nv5DI-jOoO4N6mhQfxnUXehsV93ma1v-RL6VRSDpgRC_mhfrf2f_U_sJY413kQ</recordid><startdate>20190501</startdate><enddate>20190501</enddate><creator>Scott, Lesley J.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7QO</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20190501</creationdate><title>Brexanolone: First Global Approval</title><author>Scott, Lesley J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-4a277e178f4510f6c878d9b144076af9d511acfd00d36609184c21a3a922d5483</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>AdisInsight Report</topic><topic>Administration, Intravenous - methods</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Adults</topic><topic>Allosteric properties</topic><topic>Allosteric Regulation - drug effects</topic><topic>Anesthesia</topic><topic>beta-Cyclodextrins - administration & dosage</topic><topic>beta-Cyclodextrins - adverse effects</topic><topic>beta-Cyclodextrins - pharmacokinetics</topic><topic>beta-Cyclodextrins - pharmacology</topic><topic>beta-Cyclodextrins - therapeutic use</topic><topic>Breastfeeding & lactation</topic><topic>Cyclodextrins</topic><topic>Depression, Postpartum - drug therapy</topic><topic>Drug Approval</topic><topic>Drug Combinations</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination - methods</topic><topic>FDA approval</topic><topic>Female</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Mental depression</topic><topic>Metabolites</topic><topic>Middle Aged</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Postpartum depression</topic><topic>Pregnanolone</topic><topic>Pregnanolone - 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Academic</collection><jtitle>Drugs (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Scott, Lesley J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Brexanolone: First Global Approval</atitle><jtitle>Drugs (New York, N.Y.)</jtitle><stitle>Drugs</stitle><addtitle>Drugs</addtitle><date>2019-05-01</date><risdate>2019</risdate><volume>79</volume><issue>7</issue><spage>779</spage><epage>783</epage><pages>779-783</pages><issn>0012-6667</issn><issn>1179-1950</issn><eissn>1179-1950</eissn><abstract>Brexanolone (ZULRESSO™) is an intravenously administered, small molecule, neuroactive steroid GABA
A
receptor positive allosteric modulator that was developed by Sage Therapeutics under license to the University of California for the treatment of postpartum depression (PPD). The formulation is a mixture of allopregnanolone, an endogenous inhibitory pregnane neurosteroid, and sulfobutylether-beta-cyclodextrin (a solubilizing agent). In mid-March 2019 brexanolone received its first global approval in the USA for the treatment of PPD in adult women. This article summarizes the milestones in the development of brexanolone leading to its first approval for the treatment of adult women with PPD.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>31006078</pmid><doi>10.1007/s40265-019-01121-0</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0012-6667 |
| ispartof | Drugs (New York, N.Y.), 2019-05, Vol.79 (7), p.779-783 |
| issn | 0012-6667 1179-1950 1179-1950 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2212716730 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | AdisInsight Report Administration, Intravenous - methods Adolescent Adult Adults Allosteric properties Allosteric Regulation - drug effects Anesthesia beta-Cyclodextrins - administration & dosage beta-Cyclodextrins - adverse effects beta-Cyclodextrins - pharmacokinetics beta-Cyclodextrins - pharmacology beta-Cyclodextrins - therapeutic use Breastfeeding & lactation Cyclodextrins Depression, Postpartum - drug therapy Drug Approval Drug Combinations Drug dosages Drug therapy Drug Therapy, Combination - methods FDA approval Female Humans Internal Medicine Medicine Medicine & Public Health Mental depression Metabolites Middle Aged Pharmacology/Toxicology Pharmacotherapy Postpartum depression Pregnanolone Pregnanolone - administration & dosage Pregnanolone - adverse effects Pregnanolone - pharmacokinetics Pregnanolone - pharmacology Pregnanolone - therapeutic use Receptors, Steroid - metabolism Steroids Treatment Outcome United States United States Food and Drug Administration β-Cyclodextrin γ-Aminobutyric acid A receptors |
| title | Brexanolone: First Global Approval |
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