Palm Beach, FL –October 27, 2021 – FinancialNewsMedia.com News Commentary – Among the race to see what psychedelic drugs can do, ketamine is a step ahead of all other drugs, because it has already been legal for quite some time. Ketamine was originally popularized as an anesthetic. However, it has been used off-label for many years to treat pain conditions. According to an article on WebMD, Ketamine got its start in Belgium in the 1960s as an anesthesia medicine for animals. The FDA approved it as an anesthetic for people in 1970. It was used in treating injured soldiers on the battlefields in the Vietnam War. Unlike other anesthetics, ketamine doesn’t slow breathing or heart rate, so patients don’t need to be on a ventilator to receive it. More recently, it has also been used off-label in the treatment of mental health disorders, most notably depression, PTSD and addiction. Ketamine also produces a “dissociative experience” (or “trip”) like other psychedelics, and it is also used illicitly. But ketamine avoided the drug Prohibition deep-freeze that banished other psychedelic drugs from even valid research purposes for many years. Ketamine causes what doctors call a “dissociative experience” and what most anyone else would call a “trip.” That’s how it became a club drug, called K, Special K, Super K, and Vitamin K among others. Partiers inject it, put it in drinks, snort it, or add it to joints or cigarettes. “Ketamine can produce feelings of unreality; visual and sensory distortions; a distorted feeling about one’s body; temporary unusual thoughts and beliefs; and a euphoria or a buzz,” says John Krystal, MD, chief of psychiatry at Yale-New Haven Hospital and Yale School of Medicine in Connecticut, where he is a leader in studying ketamine’s antidepressant effects. Active Biotechs in the markets today include: Pasithea Therapeutics Corp. (NASDAQ: KTTA), atai Life Sciences (NASDAQ: ATAI), FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE), Sage Therapeutics, Inc. (NASDAQ: SAGE), Alkermes plc (NASDAQ: ALKS).
But the drug’s potential as a treatment for depression and antidote to suicidal thoughts has drawn researchers’ attention. They’ve studied and administered it in controlled, clinical settings to help with treatment-resistant depression and other conditions. “We’re reaching out in a new way to patients who have not responded to other kinds of treatments and providing, for some of them, the first time that they’ve gotten better from their depression,” Krystal says. Ketamine comes in several forms. The only one that the FDA has approved as a medication for depression is a nasal spray called esketamine (Spravato). It’s for adults who either haven’t been helped by antidepressant pills, have major depressive disorder, or are suicidal.
Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Announces Successful Treatment of First Patients in the UK with Ketamine Infusion Therapy – Pasithea erapeutics Corp. (Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that Pasithea Clinics, its wholly owned subsidiary has administered intravenous (“IV”) ketamine therapy to its first patients. In sub-anesthetic doses, ketamine has shown to be highly effective at treating some psychiatric disorders, such as treatment-resistant depression and post-traumatic stress disorder.
“With major depression the leading cause of long-term disability worldwide and mental health cases on the rise, new therapies are urgently needed for patients who do not respond to traditional treatments. Today, we are thrilled to announce that we administered our first IV ketamine infusion therapy to patients with treatment-resistant depression,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics.
“This is a significant milestone for Pasithea Clinics and for patients in the U.K. suffering with mental health conditions. Decades of evidence supports the efficacy of ketamine in improving symptoms for some mental health disorders, and studies have shown that up to 70% of those who receive IV ketamine treatment will eventually show a clinical response. We are excited to continue providing treatment to patients deemed eligible to receive it,” concluded Dr. Reis Marques.
Ketamine is a U.S. Food and Drug Administration (“FDA”) approved drug introduced as an anesthetic more than 50 years ago. It has recently been repurposed in significantly lower doses for the treatment of psychiatric disorders and is now gaining ground as a promising treatment for mental health disorders. In certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”), it has shown remarkable efficacy and a rapid and sustained effect.
Pasithea has clinical partnerships to administer its IV ketamine treatment. In the U.K., it has partnered with ZEN Healthcare – a network of health clinics in London. In the U.S., it has partnered with The IV Doc, Inc. to provide in-home IV ketamine infusions. Both partnerships offer rapid exposure and expansion opportunities. CONTINUED… Read the Pasithea Therapeutics full press release by going to: https://ir.pasithea.com/
In other biotech news in the markets this week:
FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, recently announced it has entered into an agreement with Covar Pharmaceuticals Inc. (“Covar”), a contract development and manufacturing services organization (“CDMO”), to commence work on providing research quantities of FSD’s drug candidate, Lucid-PSYCH, on an exclusive basis for further clinical evaluation.
A psychoactive compound, Lucid-PSYCH (formerly Lucid-201) has been selected by FSD to advance its research into the treatment of major depressive disorders based on analysis of the drug candidate’s pharmaceutical and metabolic properties processed via machine learning algorithms, as well as for its potential proprietary position.
Sage Therapeutics, Inc. (NASDAQ: SAGE) and Biogen Inc. (BIIB) recently announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the LANDSCAPE and NEST programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages.
“In the pre-NDA meeting, the FDA’s response on the regulatory pathway for zuranolone continued to be consistent with previous discussions. In the clinical development programs, zuranolone has shown remarkably consistent, rapid, and sustained reductions in depressive symptoms, including anxiety and sleep loss, in addition to a well-tolerated safety profile. We believe we have a solid filing package with four adequate and well controlled trials now in hand and, if approved, zuranolone will fill a real unmet need and be welcomed by people living with depression,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “We have identified what we believe is the most efficient path forward for an FDA filing and potential approval.”
atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, recently announced the launch of PsyProtix, a new platform company formed with Chymia LLC, a Duke University biotechnology spinout. PsyProtix is a precision psychiatry company focused on developing therapeutics for treatment-resistant depression (TRD) and other mental health indications.
PsyProtix takes a precision psychiatry approach, an emerging field that aims to treat disorders by factoring each patient’s variability in genes, metabolism, environment, and lifestyle. Traditionally, psychiatric patients are diagnosed and treated based on guidelines and protocols designed for the majority, which can often lead to trial and error as physicians attempt to best meet each individual patient’s needs.
Alkermes plc (NASDAQ: ALKS) recently announced that LYBALVI® (olanzapine and samidorphan) is now available by prescription in the United States (U.S.) for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes as monotherapy or an adjunct to lithium or valproate. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.
“Alkermes has long been focused on the research, development and manufacture of new medicines that seek to address real-world patient needs and is committed to being a leader in the treatment of serious mental illness. Today, we’re pleased to announce the commercial availability of LYBALVI, our first oral antipsychotic medicine, for adults living with schizophrenia or bipolar I disorder,” said Todd Nichols, Chief Commercial Officer at Alkermes. “We have been building our commercial capabilities and presence in the antipsychotic market over the last five years and plan to leverage this experience as we expand our psychiatry franchise and bring LYBALVI to market. We look forward to engaging with healthcare providers and supporting patient access to LYBALVI as we drive awareness of this important new treatment option.”
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