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Seventeen years since rimonabant's downfall: reassessing its suicidality risk profile.
Cohen, Yuval; Kolodziej, Andrew; Morningstar, Marshall.
Affiliation
  • Cohen Y; Corbus Pharmaceuticals Holdings Inc., Norwood, Massachusetts, USA.
  • Kolodziej A; Corbus Pharmaceuticals Holdings Inc., Norwood, Massachusetts, USA.
  • Morningstar M; Corbus Pharmaceuticals Holdings Inc., Norwood, Massachusetts, USA.
Obesity (Silver Spring) ; 32(7): 1235-1244, 2024 07.
Article de En | MEDLINE | ID: mdl-38887179
ABSTRACT
Targeting the cannabinoid type 1 receptor (CB1) is a clinically validated antiobesity therapeutic approach. The only such drug approved, rimonabant, was launched in 2006 in Europe but subsequently rejected by the US Food and Drug Administration (FDA) in 2007. The FDA cited the increased risk of suicidality in its opposition to rimonabant's approval, leading to the drug's eventual worldwide withdrawal and the abandonment of this class of therapeutics. Seventeen years later, a new class of CB1-targeting drugs is emerging, but the impact of the 2007 FDA decision remains a formidable obstacle to its clinical development. We revisit the suicidality data presented by the FDA in light of the evolution of suicidality assessment and cross-reference this with the data in the subsequently published clinical trials. We conclude that the publicly available data do not support the FDA's conclusion that the use of rimonabant was associated with an increase in the risk of suicidality.
Sujet(s)

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Suicide / Food and Drug Administration (USA) / Agents antiobésité / Rimonabant Limites: Humans Pays/Région comme sujet: America do norte Langue: En Journal: Obesity (Silver Spring) Sujet du journal: CIENCIAS DA NUTRICAO / FISIOLOGIA / METABOLISMO Année: 2024 Type de document: Article Pays d'affiliation: États-Unis d'Amérique Pays de publication: États-Unis d'Amérique

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Suicide / Food and Drug Administration (USA) / Agents antiobésité / Rimonabant Limites: Humans Pays/Région comme sujet: America do norte Langue: En Journal: Obesity (Silver Spring) Sujet du journal: CIENCIAS DA NUTRICAO / FISIOLOGIA / METABOLISMO Année: 2024 Type de document: Article Pays d'affiliation: États-Unis d'Amérique Pays de publication: États-Unis d'Amérique