The FDA continues to signal openness to psychedelic-based therapies. Following its recent Breakthrough Therapy Designation (BTD) for a potential LSD-based anxiety treatment, the agency has extended the same status to Cybin Inc.‘s CYB003 for major depressive disorder (MDD). The move marks the first FDA Breakthrough Therapy Designation for an adjunctive, psychedelic-based Major Depressive Disorder treatment.…
Cybin sees near future for psychedelic therapy after promising interim phase 2 data
With promising interim phase 2 data in hand, Cybin believes psychedelic therapy will become a reality in the “not too distant future,” according to CEO Doug Drysdale. As recently as the 1990s, it would be difficult to imagine that a psychedelic drug would potentially be a clinical option for a mood disorder like depression. But…
Early data suggest adjunctive cariprazine could be a promising tool for tackling stubborn anhedonia in MDD
The dopamine D3 receptor-targeting cariprazine could potentially be a new tool for managing anhedonia, one of the most stubborn symptoms of major depressive disorder (MDD). Characterized by a lack of enjoyment in previously pleasurable activities, anhedonia has been “difficult to address with traditional antidepressants,” said Dr. Vladimir Maletic, coauthor of a poster presented at the…
FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder
FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness. The former approval represents a milestone as the first ever…
Cybin updates on its psychedelic-based therapeutics at R&D Day
Psychedelic therapy company Cybin (NEO:CYBN/NYSE American:CYBN) hosted a virtual R&D Day on February 28, 2023. In the event, the company’s leadership team provided an update on its development pipeline of deuterated psychedelic-based therapeutics, including CYB003 and CYB004. CYB003 is synthetic psilocybin analog, for the potential treatment of major depressive disorder. Cybin provided an interim readout from…
Pharmacogenomic testing reduced drug-gene interactions in depressed patients
A study of 1,944 patients published in JAMA found that pharmacogenomic testing helped to minimize drug-gene interactions in patients with major depressive disorder (MDD) but had little to no effect on symptom remission at 24 weeks. In the randomized trial, 45% of patients who received pharmacogenomic testing had no predicted drug-gene interactions. Of those who received standard…
Cybin files IND with FDA for early human study focused on major depressive disorder
The biopharma Cybin Inc. (NYSEAMERICAN:CYBN) has filed a submission of an Investigational New Drug (IND) application with the FDA for its Phase 1/2a first-in-human clinical trial focused on CYB003. CYB003 is a proprietary psilocybin analog as a proposed treatment of major depressive disorder (MDD) as an adjunct to psychotherapy. The study would enroll approximately 40…
AbbVie touts positive cariprazine data in major depressive disorder
The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in a Phase 3 3111-301-001 study involving patients with major depressive disorder (MDD). AbbVie (NYSE:ABBV) is aiming to win a new FDA indication for the drug as an adjunctive treatment of MDD by the end of the year. According to MedPage Today, 44%…
AbbVie files supplemental New Drug Application with FDA for cariprazine
AbbVie (NYSE: ABBV) has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar) for major depressive disorder (MDD). FDA first approved cariprazine for schizophrenia and bipolar disorder in 2015. Current indications of the drug cover the acute treatment of manic or mixed episodes related to bipolar I disorder and depressive episodes associated with bipolar…
Small Pharma Inc. plans Phase 2b trial of DMT for depression
Small Pharma Inc. (TSXV:DMT) is prepping a Phase 2b clinical study to test the use of its lead candidate, SPL026, an N, N-dimethyltryptamine (DMT) in treating major depressive disorder (MDD). DMT is present in Ayahuasca, a South American psychedelic brew. The company has announced that it has had positive discussions with FDA regarding the planned…
Zuranolone shows promise in treating postpartum depression
Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression. The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.…