Research Uncovers New Role Psychedelics Could Play in Therapy

NEW YORK, June 25, 2020 /PRNewswire/ -- The pharmaceutical industry develops drugs to diagnose, cure, treat or prevent diseases and it operates in one of the most diverse and complex markets. The pharmaceutical market is also expected to grow in the coming years, despite the recent growth slowdown felt around the globe. Geographically, North America is expected to retain its leading position in the global pharmaceuticals market with a market share of 45.33% in 2023, improving on its market share compared to 2017.  The reasons for the growth projections are the aging and rising population, increasing income levels and emerging medical conditions, including new diseases. Of course, innovations in advanced technology and biologics, nucleic acid therapeutics, cell therapies and bioelectronics & implantables has already attracted investments to the pharmaceutical market. And, in recent years, new segments have appeared that previously were considered taboo, like cannabis and psychedelics. Now, according to NAVADHI Market Research, the global pharmaceutical industry will be worth USD 1.57 Trillion by 2023. Mydecine Innovations Group Inc. MYCOF MYCO, Takeda Pharmaceutical Company Limited TAK, Teva Pharmaceutical Industries Limited TEVA, Marinus Pharmaceuticals, Inc. MRNS, Supernus Pharmaceuticals, Inc. SUPN

One of the developing segments in pharmaceuticals is psychopharmacology, which is the scientific study of the effects drugs have on mood, sensation, thinking, and behavior. It is distinguished from neuropsychopharmacology, which emphasizes the correlation between drug-induced changes in the functioning of cells in the nervous system and changes in consciousness and behavior. Examples of conditions that can be treated or managed by such drugs are anxiety disorders and depression. Psychopharmacology is quickly becoming a part of many large research programs found in universities, government labs, and pharmaceutical companies around the world. Antidepressants are used to treat Major Depressive Disorder (MDD) as well as anxiety disorders including panic disorder, phobias, obsessive-compulsive disorder, and traumatic stress diseases. Overall, the rising incidence of depression worldwide is anticipated to further drive this segment's growth in the coming years.

Mydecine Innovations Group Inc. MYCOF MYCO announced earlier this week breaking news that, "the addition of two key strategic advisors to the company's Scientific Advisory Committee.

The new members of the science team will provide scientific expertise and corporate strategy support as Mydecine begins its R&D program at its Innovation Center in Denver, Colorado. The advisory committee will review/monitor/access specific protocols and serve as an advocate for the organization providing technical expertise and collaborating with team members to help shape the direction of the various research programs.

Vince Polito is a Research Fellow at Macquarie University and former Associate Investigator at the Australian Research Council Centre of Excellence in Cognition and its Disorders. Mr. Polito's research aims to understand how self-monitoring changes, self-representation, sense of agency, belief formation and altered states of consciousness. Vince's research has been profiled in The Guardian, BBC, Buzzfeed, Nine News, Vice and many others.

Last year, Mr. Polito conducted one of the largest to date Microdosing of psychedelics studies. In this research his team investigated the short- and long-term effects of microdosing on wellbeing, cognition and agency. The study conducted was a systematic, observational investigation of individuals who microdose (regular ingestion of very small quantities of psychedelic substances). The study tracked the experiences of microdosing participants, who provided daily ratings of psychological functioning over a six-week period and completed a battery of psychometric measures tapping mood, attention, wellbeing, mystical experiences, personality, creativity, and sense of agency, at baseline and at completion of the study. Analysis of pre and post study measures revealed reductions in reported levels of depression and stress; lower levels of distractibility; increased absorption; and increased neuroticism.

Anton Gomez-Escolar is a Psychopharmacology expert based in Madrid, Spain. Mr. Gomez-Escolar has a technical understanding of neurobiology, psychopharmacology, psychedelics, nootropics, drug safety and clinical trial development. Mr. Gomez-Escolar has a Masters in Psychopharmacology from Spain's largest university Complutense University of Madrid, including a Master Thesis on the topic of "Psychedelics in psychotherapy for the treatment of depression and addiction," a Masters in International Relations by Griffith University from Australia, and many other diplomas including a certificate of Design and Interpretation of Clinical Trials from John Hopkins School of Public Health, a certificate in Drug Discovery, Development & Commercialization from UCSD and a certificate in Drug Use, Policy and Health from the University of Geneva.

Mr. Gomez-Escolar is the co-founder of the Psychedelic Society of Madrid, attended and presented many international conferences on the topic and has worked for the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), the official European Union drugs information agency as well as Laboratorios Equisalud, a leading laboratory in holistic phytotherapy and nutritional supplements.

Rob Roscow, CSO and Director commented: 'Our Scientific Advisory Board provides Mydecine independent, expert, multi-disciplinary, and strategic advice on scientific programs, emerging health science issues and trends in the psychedelic medicine sector. We are actively expanding our operations and we are thrilled to add these two talented individuals to our growing team.'"

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Takeda Pharmaceutical Company Limited TAK announced last year that the MHLW of Japan approved Trintellix® (vortioxetine) for the treatment of depression and depressed state. Vortioxetine is already approved in 83 countries, including US, Europe, Canada, Chile, China, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa. "I am pleased that individuals suffering from depression in Japan now also have access to this important treatment option. Today's approval of Trintellix, furthermore, represents a new chapter in Lundbeck's commercial expansion as we will have our own commercial organization behind the launch of Trintellix in Japan in collaboration with our partner Takeda" said Jacob Tolstrup, Executive Vice President, Commercial Operations at Lundbeck.

Teva Pharmaceutical Industries Limited TEVA reported last year the FOCUS exploratory endpoints results at the 5th Congress of the European Academy of Neurology (EAN), Oslo, Norway from June 29th - July 2nd, 2019. These results include reduction in monthly average migraine days; reduction in migraine related symptoms; and improvements in depression status; work productivity and activity impairment. Migraine patients are estimated to be approximately 2-4 times more likely to have depression than the general population. Depression status was evaluated as an exploratory endpoint in the study. Improvements in depression status were observed with monthly fremanezumab versus placebo, and to a lesser degree with the quarterly dose. "Migraine is the second leading cause of years lived with disability worldwide with profound impact on patients, their families and friends, and on society as a whole. Data from the FOCUS study disclose the results of fremanezumab on a range of quality of life and disability measures as well as demonstrating a significant reduction in the number of headache hours and days suffered by patients and on a spectrum of associated symptoms," commented Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache.

Marinus Pharmaceuticals, Inc. MRNS has initiated the first ever pivotal studies in children with CDKL5 deficiency disorder and PCDH19-related epilepsy, and is currently conducting studies in patients with postpartum depression and refractory status epilepticus. In recent years, announced that it has initiated its Phase 2 double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy and pharmacokinetics (PK) of ganaxolone IV in women diagnosed with severe postpartum depression (Magnolia study).  The clinical development plan with ganaxolone in postpartum depression (PPD) includes the Magnolia study, along with the soon to be initiated study to evaluate ganaxolone oral capsules in moderate PPD patients (Amaryllis study). PPD is a debilitating neuropsychiatric disorder that occurs following childbirth and can severely affect a mother's ability to care for her child. "Initiating this trial in women with postpartum depression is an important milestone for Marinus as we expand the therapeutic reach of ganaxolone into neuropsychiatric disorders," commented Christopher M. Cashman, Chief Executive Officer of Marinus Pharmaceuticals. "Postpartum depression occurs in one out of nine women who have given birth. We believe there is a strong mechanistic rationale for ganaxolone to provide a meaningful therapeutic benefit to these mothers struggling with PPD for which there are no approved therapies."

Supernus Pharmaceuticals, Inc. SUPN announced earlier this year that the U.S. Food and Drug Administration (FDA) has found the New Drug Application (NDA) for SPN-812 for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD) acceptable for review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 8, 2020. "SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade," said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "This is critical for the nearly 6.1 million children and adolescents in the U.S. who are diagnosed with the condition and are in need of a treatment that is a non-controlled substance and that works differently from currently available treatments." SPN-812 is a serotonin norepinephrine modulating agent (SNMA) that Supernus is developing as a novel non-stimulant for the treatment of ADHD. Based on data generated to date, the Company believes SPN-812 could be a well-differentiated ADHD treatment compared to other treatments for ADHD due to its novel mechanism of action and unique pharmacological and pharmacokinetic profile. The active ingredient in SPN-812, viloxazine hydrochloride, has an extensive safety record in Europe, where it was previously marketed for many years as an antidepressant.

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