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Kaya Holdings, Inc. (OTCQB:KAYS) Criticizes FDA Rejection of MDMA Therapy for PTSD, Proposes Psilocybin as Alternative Treatment

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Kaya Holdings, Inc. (OTCQB:KAYS) criticizes the FDA's rejection of MDMA therapy for PTSD and proposes psilocybin as an alternative treatment. KAYS operates The Sacred Mushroom™, an 11,000 sq. ft. legally licensed psilocybin treatment center in Portland, Oregon. CEO Craig Frank invites researchers and individuals to consider psilocybin treatment at their facility. Emerging research suggests psilocybin's potential in treating PTSD, with studies showing reduced symptoms after just one or two sessions. Compared to MDMA, psilocybin offers longer sessions, milder side effects, and a preferred safety profile regarding abuse potential and dependency risk. The company emphasizes that psilocybin is not federally legal in the US and advises consulting a physician before making changes to prescription drug treatments.

Kaya Holdings, Inc. (OTCQB:KAYS) critica il rifiuto della FDA alla terapia con MDMA per il PTSD e propone la psilocibina come trattamento alternativo. KAYS gestisce The Sacred Mushroom™, un centro di trattamento psilocibina legalmente autorizzato di 11.000 piedi quadrati a Portland, Oregon. Il CEO Craig Frank invita i ricercatori e gli individui a considerare il trattamento con psilocibina presso la loro struttura. Ricerche emergenti suggeriscono il potenziale della psilocibina nel trattamento del PTSD, con studi che mostrano una riduzione dei sintomi dopo solo una o due sessioni. Rispetto all'MDMA, la psilocibina offre sessioni più lunghe, effetti collaterali più lievi e un profilo di sicurezza preferito riguardo al potenziale di abuso e al rischio di dipendenza. L'azienda sottolinea che la psilocibina non è legale a livello federale negli Stati Uniti e consiglia di consultare un medico prima di apportare modifiche ai trattamenti farmacologici prescritti.

Kaya Holdings, Inc. (OTCQB:KAYS) critica el rechazo de la FDA a la terapia con MDMA para el PTSD y propone la psilocibina como tratamiento alternativo. KAYS opera The Sacred Mushroom™, un centro de tratamiento de psilocibina legalmente autorizado de 11,000 pies cuadrados en Portland, Oregón. El CEO Craig Frank invita a investigadores e individuos a considerar el tratamiento con psilocibina en su instalación. Investigaciones emergentes sugieren el potencial de la psilocibina para tratar el PTSD, con estudios que muestran una reducción de los síntomas después de solo una o dos sesiones. En comparación con el MDMA, la psilocibina ofrece sesiones más largas, efectos secundarios más suaves y un perfil de seguridad preferido en cuanto al potencial de abuso y riesgo de dependencia. La empresa enfatiza que la psilocibina no es legal a nivel federal en los EE. UU. y aconseja consultar a un médico antes de realizar cambios en los tratamientos farmacológicos prescritos.

Kaya Holdings, Inc. (OTCQB:KAYS)는 PTSD 치료를 위한 MDMA 요법의 FDA 거부를 비판하며 대체 치료로서의 실로시빈을 제안합니다. KAYS는 오리건주 포틀랜드에 위치한 11,000제곱피트의 법적으로 허가된 실로시빈 치료 센터인 The Sacred Mushroom™을 운영하고 있습니다. CEO Craig Frank는 연구자와 개인들이 그들의 시설에서 실로시빈 치료를 고려해 줄 것을 초대합니다. 새롭게 등장하는 연구에 따르면 실로시빈이 PTSD 치료에 잠재력이 있음을 보여주며, 단 한두 세션 후에 증상이 줄어든다는 연구 결과가 있습니다. MDMA와 비교할 때, 실로시빈은 더 긴 세션, 더 온화한 부작용 및 선호되는 안전 프로필을 제공합니다. 회사는 실로시빈이 미국에서 연방 차원에서 합법이 아니며, 처방 약물 치료를 변경하기 전에 의사와 상담할 것을 권장합니다.

Kaya Holdings, Inc. (OTCQB:KAYS) critique le rejet de la thérapie à base de MDMA pour le PTSD par la FDA et propose la psilocybine comme traitement alternatif. KAYS gère The Sacred Mushroom™, un centre de traitement à base de psilocybine légalement autorisé de 11 000 pieds carrés à Portland, dans l'Oregon. Le PDG Craig Frank invite les chercheurs et les individus à envisager un traitement à base de psilocybine dans leur établissement. Des recherches émergentes suggèrent le potentiel de la psilocybine dans le traitement du PTSD, des études montrant une réduction des symptômes après une ou deux séances seulement. Comparé à la MDMA, la psilocybine offre des séances plus longues, des effets secondaires plus légers et un profil de sécurité préféré en matière de potentiel d'abus et de risque de dépendance. L'entreprise souligne que la psilocybine n'est pas légale au niveau fédéral aux États-Unis et recommande de consulter un médecin avant d'apporter des modifications aux traitements médicamenteux prescrits.

Kaya Holdings, Inc. (OTCQB:KAYS) kritisiert die Ablehnung der MDMA-Therapie für PTSD durch die FDA und schlägt Psilocybin als alternative Behandlung vor. KAYS betreibt The Sacred Mushroom™, ein gesetzlich lizenziertes Psilocybin-Behandlungszentrum mit einer Fläche von 11.000 Quadratfuß in Portland, Oregon. CEO Craig Frank lädt Forscher und Einzelpersonen ein, die Psilocybin-Behandlung in ihrer Einrichtung zu erwägen. Neue Forschungen deuten auf das Potenzial von Psilocybin zur Behandlung von PTSD hin, wobei Studien zeigen, dass die Symptome bereits nach ein oder zwei Sitzungen verringert werden. Im Vergleich zu MDMA bietet Psilocybin längere Sitzungen, mildere Nebenwirkungen und ein bevorzugtes Sicherheitsprofil hinsichtlich Missbrauchspotential und Abhängigkeitsrisiko. Das Unternehmen betont, dass Psilocybin auf Bundesebene in den USA nicht legal ist und rät, vor Änderungen der verschreibungspflichtigen Behandlungen einen Arzt zu konsultieren.

Positive
  • KAYS operates a legally licensed 11,000 sq. ft. psilocybin treatment center in Oregon
  • Emerging research supports psilocybin's potential in treating PTSD
  • Psilocybin offers longer treatment sessions compared to MDMA
  • Psilocybin has milder side effects and a better safety profile than MDMA
Negative
  • Psilocybin is not federally legal in the United States
  • FDA's rejection of MDMA therapy may impact the development of psychedelic treatments
  • Results of psilocybin treatment may vary

FT. LAUDERDALE, FL / ACCESSWIRE / August 13, 2024 / Kaya Holdings, Inc., ("KAYS" or the "Company") (OTCQB:KAYS), a "mind care" company with operations in the emerging psilocybin treatment sector and in medical/recreational cannabis, criticized the FDA ruling rejecting MDMA (Ecstasy) therapy as a treatment for PTSD. KAYS, which provides psilocybin treatment services at its Portland, Oregon facility, The Sacred Mushroomproposes consideration of psilocybin therapy as an alternative treatment for PTSD and welcomes anyone seeking psilocybin treatment for PTSD, as permitted by Oregon law.

The Sacred Mushroom
The Sacred Mushroom™ is a legally licensed psilocybin treatment center authorized by the State of Oregon to administer psilocybin treatments within the regulations set forth by the Oregon Health Authority ("OHA").

The Sacred Mushroom™, at 11,000 sq. ft., has been purposely designed to provide every TSM guest with the full transformative potential of the psychedelic journey offered by psilocybin. Guests can access their perfect setting through TSM's proprietary "Synergy by Design" and interact with journey-enhancing activities such as art expression, body movement, and journaling.

A vast, free-flowing garden brings nature indoors to our Guests 7 floors above the City of Portland.


CEO Statement
Craig Frank, KAYS' CEO responded to the FDA's rejection of MDMA decision, saying, "We are deeply sorry the FDA has decided against MDMA use for the treatment of PTSD and regret the impact this may have on developing a PTSD treatment needed by so many, including numerous military veterans. It is our view that psilocybin, whose use has been authorized by the state of Oregon, offers a potential alternative for treating PTSD, and we invite researchers, organizations and individuals previously focused on using MDMA as a treatment for PTSD, to consider psilocybin treatment and view The Sacred Mushroom™ as a safe, legal space where psilocybin may be administered in a comfortable, welcoming setting."


Psilocybin as a potential alternative to MDMA as a treatment for PTSD
Emerging research has shown that psilocybin can have lasting therapeutic effects after just one or two sessions. A study published in the Journal of Psychopharmacology found that psilocybin-assisted therapy reduced symptoms of depression and anxiety in patients with life-threatening cancer, which often includes PTSD-like symptoms. Another study in Nature Medicine demonstrated that psilocybin-assisted therapy led to significant and sustained improvements in PTSD symptoms in a cohort of military veterans. The effects were particularly noted in the reduction of avoidance behaviors and hyperarousal, which are key components of PTSD.

These published studies, along with additional studies at Kings College, London and John Hopkins University in Baltimore have allowed a comparison of MDMA and psilocybin on matters of efficacy and duration, side effects, and safety profiles. A summary of the comparison reveals:

  • The time of a psilocybin experience is typically longer than the MDMA experience, and this more prolonged session could provide more time for psychological processing and integration of insights gained during the experience.

  • While psilocybin typically produces a more introspective and insightful experience with visual and auditory hallucinations, MDMA typically enhances one's feelings of empathy and connection to others without hallucinations. The introspective nature of the psilocybin experience may facilitate deeper psychological integration compared to the shorter-lasting effects of MDMA.

  • The side effects of psilocybin generally milder than those of MDMA, which include changes in heart rate, dehydration, jaw clenching, nausea, anxiety and agitation, sweating and chills.

  • Psilocybin has a preferred safety profile with regard to potential for abuse and risk of developing a dependency, compared to MDMA.

For more information regarding The Sacred Mushroomand psilocybin,

or to make an appointment for Psilocybin Services, please go to Home Page - Psilocybin Services | The Sacred Mushroom™ (thesacredmushroompdx.com)

or send an email to info@tsmpdx.com

Disclaimer
The information set forth above is for general consumer understanding and education and should not be considered or used as a substitute for medical advice, diagnosis or treatment. Psilocybin is not an alternative to any prescription drug. A physician should be consulted prior to making any changes in prescription drug treatment.

The information set forth above and the information contained herein has not been evaluated by the FDA. Psilocybin is not intended to diagnose, treat or cure any disease. Results of psilocybin treatment may vary.

Psilocybin is not federally legal in the United States.

KAYS Shareholders and Other Interested Parties - Please Update Your Contact Information:
We routinely receive calls and emails from shareholders and other interested parties seeking an update on our operations. We are asking all KAYS shareholders and interested parties to email us and confirm their contact info. Please email info@kayaholdings.com with "KAYS shareholder update" in the subject line and include your name, address, phone number and number of shares you own so that we can make sure you receive all updates and respond to inquiries. If you would like to speak to someone at the Company, please call or text 954-480-3960 and someone will get right back to you.

About Kaya Holdings, Inc. ( www.kayaholdings.com )
Kaya Holdings, Inc is a "mind care" company with operations in the emerging psilocybin treatment sector and in medical/recreational cannabis. KAYS is a fully reporting, US-based publicly traded company, listed for trading on the OTCQB market under the symbol KAYS.

In 2014 KAYS became the first US public company to own and operate a medical cannabis dispensary (in Portland, Oregon). Today, KAYS has interests in three cannabis licenses (1 in Portland Oregon, USA and 2 in Greece). Resuming its role as innovator and trend setter, the Company is again breaking ground in the United States with The Sacred Mushroom™ psychedelic treatment centers through its majority owned subsidiary, Fifth Dimension Therapeutics, Inc. ("FDT").

KAYS subsidiaries include:

Fifth Dimension Therapeutics, Inc . serves as the Company's operating branch in the psychedelic treatment sector, including operation of mushroom cultivation facilities and The Sacred Mushroom™ treatment centers

Important Disclosure
KAYS is planning execution of its stated business objectives in accordance with current understanding of state and local laws and federal enforcement policies and priorities as it relates to psychedelics and cannabis. Potential investors and shareholders are cautioned that KAYS and subsidiaries including FDT will obtain advice of counsel prior to actualizing any portion of their business plan (including but not limited to license applications for the cultivation, distribution or sale of marijuana and psychedelic products, engaging in said activities or acquiring existing production/sales operations). Advice of counsel with regard to specific activities of KAYS, federal, state, or local legal action or changes in federal government policy and/or state and local laws may adversely affect business operations and shareholder value.

Forward-Looking Statements
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, acceptance of the Company's current and future products and services in the marketplace, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

CONTACT:
W. David Jones
954-480-3960

SOURCE: Kaya Holdings



View the original press release on accesswire.com

FAQ

What is Kaya Holdings' (KAYS) stance on the FDA's rejection of MDMA therapy for PTSD?

Kaya Holdings (KAYS) criticizes the FDA's rejection of MDMA therapy for PTSD and proposes psilocybin as an alternative treatment option.

Where does KAYS offer psilocybin treatment services?

KAYS offers psilocybin treatment services at its facility called The Sacred Mushroom™, located in Portland, Oregon.

How does psilocybin compare to MDMA for PTSD treatment according to KAYS?

KAYS suggests that psilocybin offers longer treatment sessions, milder side effects, and a better safety profile regarding abuse potential and dependency risk compared to MDMA.

Is psilocybin legal for PTSD treatment according to KAYS?

KAYS states that psilocybin use is authorized by the state of Oregon, but it is not federally legal in the United States.

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