Ketamine

Empery Alleges Critical Clinical Trial Misrepresentations by Seelos Therapeutics

Retrieved on: 
Tuesday, October 10, 2023

Empery Asset Management, LP (“Empery”) wishes to inform shareholders of Seelos Therapeutics, Inc (the “Company” or “Seelos”) that Empery transmitted a letter to management and the board of directors of Seelos alleging material misrepresentations that the Company’s CEO made regarding the SLS-002 Phase II Study in Adults with Major Depressive Disorder at Imminent Risk of Suicide (the “Trial”).

Key Points: 
  • Empery Asset Management, LP (“Empery”) wishes to inform shareholders of Seelos Therapeutics, Inc (the “Company” or “Seelos”) that Empery transmitted a letter to management and the board of directors of Seelos alleging material misrepresentations that the Company’s CEO made regarding the SLS-002 Phase II Study in Adults with Major Depressive Disorder at Imminent Risk of Suicide (the “Trial”).
  • The Company represented to Empery that its March 2023 financing would be sufficient to complete the Trial as publicly disclosed.
  • Empery believes that the Trial was doomed because the Company did not seek the appropriate funds to run a properly powered Trial.
  • Currently, Empery believes that management's and the board's misconduct have significantly damaged Empery, and it is seeking recovery from Seelos.

The Ketamine Healing Clinic of Los Angeles and Orange County Introduces an Innovative Approach: Combining Deep TMS and Ketamine Therapy

Retrieved on: 
Thursday, October 12, 2023

LOS ANGELES, Oct. 12, 2023 /PRNewswire-PRWeb/ -- Spearheaded by the esteemed Dr. David Mahjoubi, this groundbreaking approach has the potential to revolutionize the field of mental health by offering amplified therapeutic benefits for individuals suffering from depression, anxiety, OCD and smoking addiction. Deep TMS, a non-invasive procedure that uses magnetic fields to stimulate specific areas of the brain, has long been recognized as an effective treatment for various mental health conditions. Ketamine therapy, on the other hand, has gained significant attention in recent years for its rapid and profound effects. By combining these two powerful modalities, Dr. Mahjoubi and his team at the Ketamine Healing Clinic of Los Angeles and Orange County are paving the way for a new era of mental health treatment. This unique combination of deep TMS and ketamine therapy synergistically targets the brain's neural pathways and may provide faster and longer-lasting relief, ultimately improving the quality of life for countless individuals.

Key Points: 
  • The Ketamine Healing Clinic of Los Angeles and Orange County is proud to announce the introduction of an innovative treatment protocol that combines deep transcranial magnetic stimulation (TMS) and ketamine therapy.
  • By combining these two powerful modalities, Dr. Mahjoubi and his team at the Ketamine Healing Clinic of Los Angeles and Orange County are paving the way for a new era of mental health treatment .
  • For information on the Ketamine Healing Clinic of Los Angeles and the Ketamine Healing Clinic of Orange County please visit the website at http://www.ketaminehealing.com , or call (424) 278-4241 or (949) 514-8261.
  • Dr. David Mahjoubi, The Ketamine Healing Clinic of Los Angeles, (424) 278-4241, [email protected] , https://www.ketaminehealing.com/
    View original content to download multimedia: https://www.prweb.com/releases/the-ketamine-healing-clinic-of-los-angele...

NRx Pharmaceuticals Announces Strategic Change in Development of NRX-100 (IV Ketamine) at Dawson James Small Cap Investor Conference

Retrieved on: 
Thursday, October 12, 2023

The full presentation may be viewed on the Company's web page Link .

Key Points: 
  • The full presentation may be viewed on the Company's web page Link .
  • The Company further invites interested parties to subscribe to their email alert service stay up to date on company's progress here: NRX Email Alerts .
  • The findings of this trial confirm the results reported by Grunebaum and coworkers (Am J Psychiatry 2018;175:327 Link ) and numerous smaller trials.
  • Preliminary estimates of this regulatory focused work show that this effort is within the company's current budget.

Yale School of Medicine Expert to Receive International Mental Health Prize for Ketamine Antidepressant Discovery

Retrieved on: 
Friday, October 6, 2023

International mental health prize from the National Academy of Medicine goes to a Yale ketamine expert and colleagues.

Key Points: 
  • International mental health prize from the National Academy of Medicine goes to a Yale ketamine expert and colleagues.
  • They are being honored for their discovery of the rapid antidepressant effects of ketamine and the identification of its efficacy for treatment-resistant depression.
  • That discovery led to the development of the antidepressant Esketamine, the first mechanistically novel U.S. Food and Drug Administration (FDA)-approved antidepressant in over 50 years.
  • It is awarded annually to individuals, groups, or organizations that have demonstrated outstanding achievement in improving mental health.

Psychedelics plus psychotherapy can trigger rapid changes in the brain − new research at the level of neurons is untangling how

Retrieved on: 
Monday, October 2, 2023

Learning new skills correlates with changes in the brain, as evidenced by neuroscience research with animals and functional brain scans in people.

Key Points: 
  • Learning new skills correlates with changes in the brain, as evidenced by neuroscience research with animals and functional brain scans in people.
  • Presumably, if you master Calculus 1, something is now different in your brain.
  • Clinicians and scientists know there are times the brain can make rapid, enduring changes.
  • And here’s where it gets really interesting: Psychedelic-assisted psychotherapy appears to tap into this natural neural mechanism.

Psychedelic-assisted psychotherapy

    • However, it can be conceptualized as an altered state of consciousness with distortions of perception, modified sense of self and rapidly changing emotions.
    • Presumably there is a relaxation of the higher brain control, which allows deeper brain thoughts and feelings to emerge into conscious awareness.
    • Psychedelic-assisted psychotherapy combines the psychology of talk therapy with the power of a psychedelic experience.
    • Researchers have described cases in which subjects report profound, personally transformative experiences after one six-hour session with the psychedelic substance psilocybin, taken in conjunction with psychotherapy.

A mechanism for psychedelic-induced change

    • Psychedelics such as DMT, the active chemical in the plant-based psychedelic ayahuasca, stimulate a receptor cell type, called 5-HT2A.
    • It’s only the 5-HT2A receptor inside the cell that facilitates rapid change in neuronal structure.
    • And it’s possible psychedelic-assisted psychotherapy uses this naturally occurring neural mechanism to facilitate healing.

A word of caution

    • The friend had a mystical experience and came away feeling deeper connections to her family and friends.
    • The U.S. Food and Drug Administration in 2019 did approve ketamine, in conjunction with an antidepressant, to treat depression in adults.
    • Psychedelic-assisted psychotherapy with MDMA (often called ecstasy or molly) for PTSD and psilocybin for depression are in Phase 3 trials.

NRx Pharmaceuticals Announces FDA Permission to Proceed on Investigational New Drug (IND) Application for NRX-101 to Treat Chronic Pain

Retrieved on: 
Monday, October 2, 2023

RADNOR, Pa., Oct. 2, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101.

Key Points: 
  • RADNOR, Pa., Oct. 2, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain under the Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) for the use of NRX-101.
  • "More than one in five adults in the United States suffers from chronic pain and patients lack options that do not carry the risk of addiction and opioid side effects.
  • Chronic pain is estimated to be a $72 billion industry today with the potential to grow to a $120 billion industry by 2033.
  • Dr. Apkarian is the inventor of the patent and a global expert in pain research and has important experience studying DCS in chronic pain.

PharmaTher Announces FDA Acceptance, As a Priority Original Abbreviated New Drug Application, for KETARX™ (Ketamine)

Retrieved on: 
Wednesday, September 27, 2023

TORONTO, Sept. 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (“FDA”) has accepted the Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”). The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024. The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.

Key Points: 
  • The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024.
  • The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.
  • PharmaTher’s priority is to commercialize KETARX™ in the U.S. through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company.
  • The Company expects to market various dosage forms of KETARX™, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

Melt Pharmaceuticals Announces Exclusive Development and License Agreement with Catalent for Its Zydis® Fast-Dissolve Technology for Use in MELT-300 for Needle- and Opioid-Free Procedural Sedation

Retrieved on: 
Tuesday, September 26, 2023

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced it recently entered into an exclusive development and license agreement with Catalent, the global leader in enabling the development and supply of better treatments across multiple modalities.

Key Points: 
  • Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced it recently entered into an exclusive development and license agreement with Catalent, the global leader in enabling the development and supply of better treatments across multiple modalities.
  • Catalent’s Zydis® ODT technology is currently used in over 35 FDA-approved and U.S.-marketed products.
  • “This exclusive license with Catalent is a key milestone for the continued development of MELT-300,” said Larry Dillaha, M.D., CEO of Melt Pharmaceuticals.
  • Melt Pharmaceuticals is currently in discussions with the FDA (U.S. Food and Drug Administration) on the Phase 3 program, which Melt expects to begin in early 2024.

Innerwell expands at-home ketamine treatment to 14 states, announces partnership with Enthea to offer psychedelic teletherapy as a workplace benefit

Retrieved on: 
Thursday, September 21, 2023

NEW YORK, Sept. 21, 2023 /PRNewswire-PRWeb/ -- Innerwell, a first-of-its-kind psychedelic teletherapy platform, is now offering care to patients in 14 states with at-home, ketamine-assisted psychotherapy alongside traditional psychiatry, therapy, and specialized modalities like eye movement desensitization and reprocessing (EMDR). Moreover, a new partnership with Enthea, a benefits plan administrator focused on ketamine-assisted therapy, allows employers to offer Innerwell ketamine therapy as a benefit to their employees.

Key Points: 
  • Moreover, a new partnership with Enthea , a benefits plan administrator focused on ketamine-assisted therapy, allows employers to offer Innerwell ketamine therapy as a benefit to their employees.
  • "We couldn't be more excited to expand access to our world-class clinical team for patients who are seeking safe and affordable treatment," said Lisa Kennedy, Innerwell founder and CEO.
  • "We are thrilled to partner with Enthea to help future-thinking employers offer innovative treatments that can have transformative outcomes.
  • "Innerwell has one of the most extensive clinical protocols for at-home-ketamine treatment that we've seen," said Sherry Rais, Enthea CEO and co-founder.

Enthea Announces Groundbreaking Nationwide Availability of Ketamine-Assisted Therapy as an Employee Benefit

Retrieved on: 
Wednesday, September 20, 2023

BOSTON, Sept. 20, 2023 /PRNewswire/ -- Enthea, the first and only licensed provider of health benefit plans that cover medication-assisted therapies, is delighted to announce that it now has national network capabilities and is able to serve U.S. employers nationwide. The news impacts the millions of people in the US living with mental health conditions and is a monumental step forward in providing access to this safe, effective treatment across America's workforce to improve employee wellness & productivity.

Key Points: 
  • Skylight offers onsite medicine experiences at Skylight Journey Centers nationwide as well as remotely to patients who prefer an at-home experience.
  • Innerwell combines legal medications, a holistic team of clinicians, and data-driven coaching, all continuously optimized based on patients outcomes.
  • Businesses interested in offering KAT for employees can simply add it as an ancillary benefit, similar to dental and vision offerings.
  • Enthea has a rapidly growing list of premium partners and employers that will be onboarded on a regular basis.