Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 289

Posts Tagged ‘depressive’

Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder

Posted by fidest press agency su lunedì, 23 dicembre 2019

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved SPRAVATO (esketamine) nasal spray, in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults living with treatment-resistant major depressive disorder (TRD). According to the approval, patients are considered to have TRD if they have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode. Major depressive disorder (MDD) affects approximately 40 million people across Europeand is the leading cause of disability worldwide.2,3 For these patients, the main goal of treatment is to relieve the symptoms of depression, and ultimately achieve remission, with few, if any, symptoms of depression remaining.4 However, about one third of patients with MDD do not respond to currently available treatments.5The approval of esketamine is based on data from a clinical trial programme in patients with TRD, including over 1,600 patients treated with esketamine. The five Phase 3 trials included three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study.6,7,8,9,10* These data demonstrated that treatment with esketamine nasal spray plus a newly initiated oral antidepressant was associated with a greater reduction in depressive symptoms compared to a newly initiated oral antidepressant plus placebo nasal spray, in adult patients (18-64 years), with the onset of efficacy as early as Day 2.6 Approximately 70 percent of esketamine-treated patients responded to treatment, with a ≥50 percent symptom reduction. Furthermore, approximately half of all treated patients achieved remission at the end of the 4 week studies.1 Continued treatment with esketamine nasal spray plus oral antidepressant reduced the risk of relapse by 70 percent among patients with stable response and by 51 percent in patients in stable remission, compared to continuing treatment with oral antidepressant alone.

Posted in Estero/world news | Contrassegnato da tag: , , , | Leave a Comment »

Psilocybin program for major depressive disorder

Posted by fidest press agency su martedì, 26 novembre 2019

Usona Institute has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for psilocybin in the treatment of major depressive disorder (MDD). Breakthrough Therapy Designation establishes FDA’s organizational commitment to promoting an efficient development program for psilocybin in MDD.The designation of psilocybin as a Breakthrough Therapy for MDD acknowledges both the unmet medical need in this broad population and the potential for significant improvements over existing therapies, and bolsters Usona’s mission to advance this revolutionary treatment paradigm toward new drug approval.“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials. What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” says Charles Raison, MD, Director of Clinical and Translational Research at Usona. “Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.” The new status follows the recent launch of Usona’s Phase 2 clinical trial, PSIL201, which will include approximately 80 participants at seven study sites around the US. Two of the seven study sites are currently recruiting, with the others expected to be active by the first quarter of 2020.

Posted in Estero/world news | Contrassegnato da tag: , , , | Leave a Comment »