Psilocybin‐assisted therapy shows clear potential for depression and other indications in recent clinical trials. While there are two FDA Breakthrough designation programmes with psilocybin for d
Treatment Resistant Depression (TRD): A Regulatory Perspective on Recent Therapeutic Developments
- 10/09/2021
- 11:30 - 12:00
- Track 4: Rudolf-Virchow Room
Abstract
Treatment resistant depression is still a therapeutic area of substantial unmet medical need. The regulatory requirements for the development of medicinal products in difficult to treat patients with Major Depressive Disorder (MDD) will be outlined with a special focus on medicinal products with new mechanisms of action and/or rapid onset of effect. A recent example (intranasal esketamine) and implications on study designs will be discussed.
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