Clinical Research Informer

Axsome bounces back as FDA clears depression drug

pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. Auvelity isn’t the first NMDA-targeting antidepressant to reach the market.

Drugs

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FDA Approval of First Rapid-Acting Oral Depression Drug + Approval of $2.8 Million Gene Therapy for Rare Blood Disorder – Xtalks Life Science Podcast Ep. 75

XTalks

AUGUST 31, 2022

In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). The approval makes Auvelity the first and only rapid-acting oral medication for depression, and the first and only oral NMDA receptor antagonist approved for MDD.

Gene Therapy

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J&J builds case for antidepressant Spravato with head-to-head trial

pharmaphorum

NOVEMBER 24, 2022

One issue has been the cost of the drug, with health technology assessment agency NICE in the UK and the ICER organisation in the US both concluding its price tag means it is not a cost-effective option for health systems.

Trials

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Axsome bounces back as FDA clears depression drug

FDA Approval of First Rapid-Acting Oral Depression Drug + Approval of $2.8 Million Gene Therapy for Rare Blood Disorder – Xtalks Life Science Podcast Ep. 75

J&J builds case for antidepressant Spravato with head-to-head trial

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