- |||||||||| Review, Journal: A Neuroanatomic and Pathophysiologic Framework for Novel Pharmacological Approaches to the Treatment of Post-traumatic Stress Disorder. (Pubmed Central) - Apr 1, 2024
Indeed, investigations and drug development are proceeding in a number of these alternative, non-serotonergic pathways in an effort to improve the management of PTSD. In this manuscript, the authors introduce novel and emerging treatments for PTSD, including drugs in various stages of development and clinical testing (BI 1358894, BNC-210, PRAX-114, JZP-150, LU AG06466, NYV-783, PH-94B, SRX246, TNX-102), established agents and known compounds being investigated for their utility in PTSD (brexpiprazole, cannabidiol, doxasoin, ganaxolone, intranasal neuropeptide Y, intranasal oxytocin, tianeptine oxalate, verucerfont), and emerging psychedelic interventions (ketamine, MDMA-assisted psychotherapy, psilocybin-assisted psychotherapy), with an aim to examine and integrate these agents into the underlying pathophysiological frameworks of trauma-related disorders.
- |||||||||| fasedienol (PH94B NS) / VistaGen
Phase classification: PH94B in the Treatment of Adjustment Disorder With Anxiety (clinicaltrials.gov) - Dec 10, 2023
P2, N=41, Completed,
Combined with subjective reports, results suggest fasedienol may provide acute relief in anxiety conditions. Phase classification: P2a --> P2
- |||||||||| fasedienol (PH94B NS) / VistaGen
Trial completion, Trial primary completion date: PH94B in the Treatment of Adjustment Disorder With Anxiety (clinicaltrials.gov) - Jul 12, 2023
P2a, N=41, Completed,
N=208 --> 324 | Recruiting --> Terminated; Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B Recruiting --> Completed | Trial primary completion date: Aug 2022 --> Dec 2022
- |||||||||| fasedienol (PH94B NS) / VistaGen
Trial completion date, Trial termination, Trial primary completion date: Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD) (clinicaltrials.gov) - Oct 31, 2022
P3, N=483, Terminated,
TEAEs occurring in ?5% of patients were headache (17.0%) and COVID-19 infection (11.4%). Trial completion date: Feb 2023 --> Sep 2022 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Sep 2022; Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B
- |||||||||| fasedienol (PH94B NS) / VistaGen
Trial completion: Palisade-1: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge (clinicaltrials.gov) - Jun 23, 2022
P3, N=209, Completed,
Trial completion date: Feb 2023 --> Sep 2022 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Sep 2022; Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B Active, not recruiting --> Completed
- |||||||||| aloradine nasal spray (PH94B NS) / VistaGen, Pherin Pharma
Brain and Peripheral Distribution of Intranasal Radiolabeled PH94B in Laboratory Rats (Palomino Ballroom 4-10) - May 6, 2022 - Abstract #ASCP2022ASCP_151;
One male and one female rat was used for autoradiographic analysis at each time point. A single intranasal administration of radiolabeled 14C-PH94B was largely confined to the nasal passages, with minimal or undetectable radiolabeled 14C-PH94B uptake in either peripheral (e.g. blood plasma, kidney, and liver) or central nervous system (CNS: olfactory lobes, cerebrum, cerebellum, and spinal cord) tissue at all time points- from 15 minutes to 504 hours after intranasal administration.
- |||||||||| fasedienol (PH94B NS) / VistaGen
Enrollment open: Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD) (clinicaltrials.gov) - Dec 2, 2021
P3, N=600, Recruiting,
A single intranasal administration of radiolabeled 14C-PH94B was largely confined to the nasal passages, with minimal or undetectable radiolabeled 14C-PH94B uptake in either peripheral (e.g. blood plasma, kidney, and liver) or central nervous system (CNS: olfactory lobes, cerebrum, cerebellum, and spinal cord) tissue at all time points- from 15 minutes to 504 hours after intranasal administration. Not yet recruiting --> Recruiting
- |||||||||| fasedienol (PH94B NS) / VistaGen
Enrollment change, Trial completion date, Trial primary completion date: PH94B in the Treatment of Adjustment Disorder With Anxiety (clinicaltrials.gov) - May 26, 2021
P2a, N=40, Not yet recruiting,
Not yet recruiting --> Recruiting N=30 --> 40 | Trial completion date: Sep 2021 --> Nov 2022 | Trial primary completion date: Jul 2021 --> Aug 2022
- |||||||||| Review, Journal: Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options. (Pubmed Central) - Jan 12, 2021
Although there are some recent randomized controlled trials for novel agents including neuropeptides, glutamatergic agents (such as ketamine and d-cycloserine), and cannabinoids (including cannabidiol) primarily in GAD or SAD, these trials have largely been negative, with only some promise for kava and PH94B (an inhaled neurosteroid). Overall, the progression of current and future psychopharmacology research in anxiety disorders suggests that there needs to be further expansion in research of these novel pathways and larger-scale studies of promising agents with positive results from smaller trials.
- |||||||||| aloradine nasal spray (PH94B NS) / VistaGen, Pherin Pharmaceuticals, Inc.
Journal, Interview: An Interview with Shawn Singh: Chief Executive Officer and Director of VistaGen Therapeutics. (Pubmed Central) - Mar 7, 2020
Overall, the progression of current and future psychopharmacology research in anxiety disorders suggests that there needs to be further expansion in research of these novel pathways and larger-scale studies of promising agents with positive results from smaller trials. No abstract available
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