major depressive disorder Archives - Medical Design Sourcing

FDA fast-tracks psilocybin-based CYB003 for depression

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. This move expedites CYB003’s review process and provides increased FDA guidance throughout development.

“I think there’s a positive attitude at the FDA,” said Doug Drysdale, CEO of Cybin. He noted that a significant number of agency representatives attended their end of Phase 2b meeting, indicating strong interest across departments. “They seem excited about the potential of these new treatments.”

FDA’s Breakthrough Designations for psychedelic and MDMA therapies

The FDA has previously granted Breakthrough Therapy Designation (BTD) to psiloc…

Cybin sees near future for psychedelic therapy after promising interim phase 2 data

[Image courtesy of Adobe Stock]

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 before long, data from multiple phase 3 trials will be available on psilocybin derivatives for various mood disorders.

Interim phase 2 CYB003 data as a ray of hope for treating mood disorders

Toronto, Canada–based Cybin recently unveiled upbeat interim phase 2 data related to CYB003, a proprietary deuterated psilocybin analog, in patients with moderate to severe major depressive disorder (MDD). In the randomized double-blind placebo-controlled study, CYB003 demonstrated a rapid and robust reduction in depression symptoms just three weeks …

Early data suggest adjunctive cariprazine could be a promising tool for tackling stubborn anhedonia in MDD

[Cariprazine image courtesy of PubChem]

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 U.S. Psych Congress annual meeting held earlier this month in Nashville.

In a post hoc analysis focusing on the adjunctive use of AbbVie’s dopamine D-preferring D3/D2 cariprazine in MDD patients with an inadequate response to one to three antidepressant therapies, patients saw a notable improvement in overall depressive symptoms and, specifically, anhedonia symptoms. This improvement, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS), was observable as early as week 2…

FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder

Zuranolone molecule image from PubChem

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 FDA-authorized oral medication specifically for PPD, a condition estimated to affect one in five new mothers.

Still, the rejection for MDD, which affects more than 21 million American adults, sent Sage’s stock valuation reeling. In early afternoon trading, SAGE shares were down 52.24% to $17.24. In contrast, Biogen stock was up 0.47% to $270.19.

Sage’s optimism for Zurzuvae in PPD treatmentt

In a business update call, CEO Barry Greene attempted to accentuate the positive. “We&#…

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 the ongoing Phase 1/2a study of CYB003.

Additionally, Cybin offered an update from the ongoing Phase 1 exploratory CYB004-E trial evaluating IV N,N-dimethyltryptamine (DMT). The company is also evaluating CYB004, a deuterated form of DMT that has a longer duration of action than traditional DMT that holds potential for generalized anxiety disorder.

Phase 2a study of CYB003

Cybin’s ongoing Phase 1/2a clinical trial of CYB003 demonstrated positive interim findings, including rapid and short-acting psychedelic responses in participants.

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Pharmacogenomic testing reduced drug-gene interactions in depressed patients

[Image by Holger Langmaier from Pixabay]

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 of care, 18% had no such interactions.

Patients in the trial were selected from Department of Veterans Affairs (VA) medical centers from July 2017 to February 2021.

“From a VA policy perspective, I don’t think that we would say the study is robust enough that we recommend testing everybody,” said Dr. David Oslin, director of VA’s VISN 4 Mental Illness, Research, Education, and Clinical Center (MIRECC). “The results were not a slam dunk, and in fact, an important outcome of the study …

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 patients, according to a description on ClinicalTrials.gov. The trials would focus on studying the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of CYB003 in patients with MDD.

The proposed study would use the Montgomery-Asberg Depression Rating Scale to gauge improvements in mood and other parameters.

Psilocybin has received a growing amount of interest in recent years. The compound is the focus of more than 50 studies, including Phase 2 studies focused on depressive and post-traumatic stress disorders.

Cybin is also investigating the potential of …

AbbVie touts positive cariprazine data in major depressive disorder

The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in the 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% of patients in the 1.5-mg arm had at least a 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score by week 2 of treatment.

The company did not divulge significant data in a news release, stating that patients receiving a 1.5mg/day dose of the drug met the primary endpoint of statistically significant improvement based on the MADRS at week six compared to placebo. Patients receiving 3.0 mg/day per day had an improved MADRS total score, but the results were not statistically significant.

Patients in the 1.5 mg group also saw improvements in their scores on the Hamilton Depression Rating Sc…

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 I disorder.

In its recent sNDA, AbbVie is attempting to secure approval of the drug as an adjunctive treatment with MDD who receive ongoing antidepressants.

Antidepressants are a cornerstone of treating depression, although experts are divided on the efficacy of antidepressants in general. One study published on InformedHealth.org found that antidepressants at large are roughly 20% more effective than placebo in treating depression.

In the submission, AbbVie included data on cariprazine recipients showing clinical improvements based on the Montgomery-Åsberg Depression Ratin…

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 trial.

“Importantly, the FDA’s feedback facilitates a path forward to prepare for the inclusion of U.S. sites in our Phase 2b clinical trial, which we anticipate will also be conducted across sites in Europe and the UK,” said Dr. Carol Routledge, chief medical and scientific officer of Small Pharma. “We believe that Small Pharma is conducting the first clinical trials of a DMT-assisted therapy for patients with MDD, with the potential to provide a much-needed alternative treatment for patients suffering from this debilitating condition.”

The company Small Pharma chose its name as a reaction to the phrase…

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.

After a 15-day treatment period, the zuranolone group had a mean change in HAM-D score of −17.8, resulting in a final mean score of 11.0, which is the normal range. Meanwhile, the −13.6 change in the placebo group results in a final mean score of 14.8, indicating mild-to-moderate depression.

For context, in the HAM-D system, a score of 10–13 indicates mild depression. The range of 14–17 represents mild to moderate depression. A score higher than 17 indicates severe depression.

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