FDA Expands Psychiatric Indications For Nasal Spray Ketamine
Last week, the FDA approved suicidal tendencies as additional qualifying symptoms for the application of Spravato, a ketamine nasal spray used in psychiatric treatment.
Spravato is the brand name for esketamine, a chemical sibling of ketamine, manufactured by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson JNJ.
In 2019, the FDA granted approval for the use of Spravato in patients with treatment-resistant depression. This indication has been amplified to include patients with acute suicidal ideation or behavior, in conjunction with an oral antidepressant.
According to the company, “Spravato is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours.”
If you or someone you know may be considering suicide, contact the National Suicide Prevention Lifeline at 1-800-273-8255 (En Español: 1-888-628-9454; Deaf and Hard of Hearing: 1-800-799-4889) or the Crisis Text Line by texting 741741.
Field Trip Opens Psychedelic-Therapy Clinic in NYC
Field Trip Psychedelics Inc. announced the opening of a psychedelic-enhanced psychotherapy clinic in Kips Bay in New York City.
The clinic will offer an integrated approach to ketamine-enhanced psychotherapy for mental wellness and health.
This is Field Trip’s second clinic, after its flagship location in Toronto. The construction of a Los Angeles clinic is currently underway, and the company plans to announce its opening later this month.
The ketamine-based treatment provided in the clinic typically lasts from three to four weeks, and includes monitoring and active psychotherapy with a qualified practitioner.
MindMed Launches Europe Subsidiary
Psychedelics company Mind Medicine Inc. MMED MMEDF announced Thursday it will open a subsidiary in Switzerland that will “oversee clinical development, scientific collaborations and the expansion of MindMed’s business in Europe,” according to a press release.
The company's board of directors appointed Dr. Miri Halperin Wernli as president of the European branch, who will oversee the expansion of the clinical and scientific team in Europe.
Dr. Halperin Wernli has over 30 years of executive experience in the pharmaceutical and biomedical industries, having held high-level positions at companies including Merck, Sharp & Dohme, Roche, and Actelion Pharmaceuticals.
Gary Smith Launches Book on Psychedelics Law and Regulation
Cannabis attorney and advocate Gary Smith announced last week the launch of Psychedelica Lex, a book marketed as the “first comprehensive book to examine laws governing psychedelic substances.”
The book is directed to individuals and organizations interested in psychedelics and entheogens, and serves as a guide to traversing the legal environment surrounding the sector.
The publication touches on the history, archaeology, anthropology, biology, religion and spirituality of these drugs, covering International drug laws and treaties, the Controlled Substances Act and other important acts, clinical trials, lobbying, public initiatives and a future outlook.
“I’ve seen plenty of texts by medical doctors, psychologists, anthropologists and enthusiasts exploring the use of psychedelics. And there are shelves of books about criminal defense,” said Smith. “However, I found nothing that anticipated taking these substances out of prohibition and through legal limbo. This gap in public knowledge fueled my desire to write Psychedelica Lex.”
The book is available on Amazon in both paperback and Kindle formats and is aimed at enthusiasts, lobbyists, policymakers, lawmakers, advocacy groups, physicians, religious leaders and business professionals.
Unlimited Sciences Partners with Johns Hopkins University
Denver-based psychedelic research nonprofit Unlimited Sciences announced Wednesday a new research study that will “greatly expand knowledge of the real-world uses and effects of psychedelic mushrooms” and psilocybin.
The study will be done in conjunction with the Johns Hopkins University Center for Psychedelic and Consciousness Research, funded by the nonprofit.
The survey will inquire current users of psilocybin mushrooms with questions before, during, and after their use of the compound, in order to better understand how the drug's effects change outside of laboratory settings, and expects to survey more than a thousand participants.
“Because our research is 'real world', allowing participants to enroll for any reason and participate in any setting, we will learn unprecedented new details about how individuals are choosing to use this substance,” said Del Jolly, co-founder and director of Unlimited Sciences.
Any adult planning on taking psilocybin sometime in the next six months is welcomed to join the study.
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