Optimi Health Completes Largest MDMA Capsule Batch to Date, Expands Stability Program
Optimi Health Corp (CSE: OPTI) (OTCQX: OPTHF) has completed its largest MDMA production batch to date, manufacturing over 4,000 GMP capsules capable of treating more than 1,000 patients. The company has achieved significant milestones in its stability program, validating a one-year shelf life for previously manufactured MDMA capsules and launching a two-year stability program.
The production will support PTSD treatment across multiple markets including Australia, Israel, and Canada. The company is currently supporting a Phase 2 clinical trial for PTSD in Israel, fulfilling Special Access Program requests in Canada, and supplying Australian patients through the Authorized Prescriber Scheme.
Optimi's in-house manufacturing capabilities, combined with its secure storage capacity for up to CAD $50 million worth of scheduled substances, positions the company to meet increasing market demand. The company reports that its MDMA offering is more cost-effective compared to market alternatives.
Optimi Health Corp (CSE: OPTI) (OTCQX: OPTHF) ha completato il suo più grande lotto di produzione di MDMA fino ad oggi, producendo oltre 4.000 capsule GMP in grado di trattare più di 1.000 pazienti. L'azienda ha raggiunto traguardi significativi nel suo programma di stabilità, convalidando una durata di scaffale di un anno per le capsule di MDMA già prodotte e avviando un programma di stabilità di due anni.
La produzione supporterà il trattamento del PTSD in diversi mercati, tra cui Australia, Israele e Canada. Attualmente, l'azienda sta supportando un trial clinico di fase 2 per il PTSD in Israele, soddisfacendo le richieste del Programma di Accesso Speciale in Canada e fornendo pazienti australiani attraverso il Programma di Prescrittore Autorizzato.
Le capacità di produzione interne di Optimi, unite alla sua capacità di stoccaggio sicuro per un valore di sostanze programmate fino a 50 milioni di CAD, posizionano l'azienda per soddisfare la crescente domanda di mercato. L'azienda riporta che la sua offerta di MDMA è più economica rispetto alle alternative di mercato.
Optimi Health Corp (CSE: OPTI) (OTCQX: OPTHF) ha completado su mayor lote de producción de MDMA hasta la fecha, fabricando más de 4,000 cápsulas GMP capaces de tratar a más de 1,000 pacientes. La compañía ha logrado hitos significativos en su programa de estabilidad, validando una vida útil de un año para las cápsulas de MDMA fabricadas anteriormente y lanzando un programa de estabilidad de dos años.
La producción apoyará el tratamiento de PTSD en múltiples mercados, incluidos Australia, Israel y Canadá. Actualmente, la compañía está apoyando un ensayo clínico de fase 2 para PTSD en Israel, cumpliendo con las solicitudes del Programa de Acceso Especial en Canadá y suministrando a pacientes australianos a través del Esquema de Prescriptores Autorizados.
Las capacidades de fabricación internas de Optimi, combinadas con su capacidad de almacenamiento seguro para hasta 50 millones de CAD en sustancias programadas, posicionan a la compañía para satisfacer la creciente demanda del mercado. La compañía informa que su oferta de MDMA es más rentable en comparación con las alternativas del mercado.
Optimi Health Corp (CSE: OPTI) (OTCQX: OPTHF)는 지금까지 최대의 MDMA 생산 배치를 완료하여 4,000개 이상의 GMP 캡슐을 제조하고 1,000명 이상의 환자를 치료할 수 있는 능력을 갖추었습니다. 이 회사는 안정성 프로그램에서 중요한 이정표를 달성하여 이전에 제조된 MDMA 캡슐의 유통 기한을 1년으로 검증하고 2년의 안정성 프로그램을 시작했습니다.
생산은 호주, 이스라엘 및 캐나다를 포함한 여러 시장에서 PTSD 치료를 지원합니다. 이 회사는 현재 이스라엘에서 PTSD에 대한 2상 임상 시험을 지원하고 있으며, 캐나다의 특별 접근 프로그램 요청을 충족하고, 호주 환자에게는 승인된 처방자 제도를 통해 공급하고 있습니다.
Optimi의 자체 제조 능력은 최대 5천만 캐나다 달러의 규제 물질을 안전하게 저장할 수 있는 능력과 결합되어 회사가 증가하는 시장 수요를 충족할 수 있는 위치에 있습니다. 이 회사는 MDMA 제품이 시장의 대안보다 더 비용 효율적이라고 보고하고 있습니다.
Optimi Health Corp (CSE: OPTI) (OTCQX: OPTHF) a achevé son plus grand lot de production de MDMA à ce jour, fabriquant plus de 4 000 capsules GMP capables de traiter plus de 1 000 patients. L'entreprise a atteint des étapes significatives dans son programme de stabilité, validant une durée de conservation d'un an pour les capsules de MDMA précédemment fabriquées et lançant un programme de stabilité de deux ans.
La production soutiendra le traitement du PTSD sur plusieurs marchés, y compris l'Australie, Israël et le Canada. Actuellement, l'entreprise soutient un essai clinique de phase 2 pour le PTSD en Israël, répondant aux demandes du Programme d'accès spécial au Canada, et fournissant des patients australiens par le biais du Schéma des prescripteurs autorisés.
Les capacités de fabrication internes d'Optimi, combinées à sa capacité de stockage sécurisé pour des substances réglementées d'une valeur allant jusqu'à 50 millions de CAD, positionnent l'entreprise pour répondre à la demande croissante du marché. L'entreprise rapporte que son offre de MDMA est plus rentable par rapport aux alternatives du marché.
Optimi Health Corp (CSE: OPTI) (OTCQX: OPTHF) hat batchgrößte MDMA-Produktion bisher abgeschlossen und über 4.000 GMP-Kapseln hergestellt, die zur Behandlung von mehr als 1.000 Patienten geeignet sind. Das Unternehmen hat bedeutende Meilensteine in seinem Stabilitätsprogramm erreicht, darunter die Validierung einer Haltbarkeit von einem Jahr für zuvor hergestellte MDMA-Kapseln und die Einführung eines zweijährigen Stabilitätsprogramms.
Die Produktion unterstützt die Behandlung von PTSD in mehreren Märkten, darunter Australien, Israel und Kanada. Das Unternehmen unterstützt derzeit eine Phase-2-Studie zu PTSD in Israel, erfüllt Anfragen des Special Access Programs in Kanada und beliefert australische Patienten über das Autorisierte Verschreiberschema.
Die internen Produktionskapazitäten von Optimi, kombiniert mit der sicheren Lagerkapazität für regulierte Substanzen im Wert von bis zu 50 Millionen CAD, positionieren das Unternehmen, um der steigenden Marktnachfrage gerecht zu werden. Das Unternehmen berichtet, dass sein MDMA-Angebot im Vergleich zu marktbasierten Alternativen kostengünstiger ist.
- Successfully manufactured largest batch of 4,000 GMP MDMA capsules to date
- Validated one-year shelf life for MDMA capsules through stability testing
- Secured multiple market channels across Australia, Israel, and Canada
- Storage capacity for CAD $50 million worth of scheduled substances
- Competitive pricing advantage in the market
- None.
Over 4,000 GMP Capsules Ready to Support PTSD Treatment in Australia, Israel, and Canada
Vancouver, British Columbia--(Newsfile Corp. - January 29, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce and supply natural, GMP-grade psilocybin and MDMA, has completed its largest production batch of MDMA to date-over 4,000 GMP capsules, enough to treat more than 1,000 patients.
As part of its commitment to ensuring long-term product stability and quality, Optimi has also completed one year of stability data on previously manufactured MDMA capsules, validating a one-year shelf life and extending the usability of its existing inventory for clinical and therapeutic applications. Additionally, the company has initiated a two-year stability program to further validate the long-term quality and reliability of its MDMA capsules.
With a growing number of authorized physicians prescribing Optimi's MDMA for PTSD in Australia, increasing demand for Special Access Program (SAP) requests in Canada, and a key Phase 2 clinical trial initiative for PTSD in Israel, Optimi is one of the few companies able to both manufacture its psychedelic drugs in-house and export cost-effective, GMP-grade MDMA capsules globally.
Highlights
- Largest batch of MDMA capsules manufactured to date
Optimi has produced over 4,000 GMP capsules of MDMA, enough to treat more than 1,000 patients globally, reinforcing its commitment to expanding access to psychedelic-assisted therapy. - One-year stability data extends current inventory
Stability testing on previously manufactured 40 mg and 60 mg MDMA capsules confirms a one-year shelf life, ensuring continued availability for clinical and therapeutic applications. - Two-year stability program launched
Optimi has initiated a two-year stability program to further validate the long-term quality and shelf life of its MDMA capsules. - Ongoing production for SAP, clinical trials, and regulated markets
Optimi is running additional GMP production of both 40 mg and 60 mg MDMA capsules in the coming weeks to support:- A Phase 2 clinical trial initiative for PTSD in Israel
- Special Access Program (SAP) requests in Canada
- Fulfilling purchase orders for Australian patients prescribed Optimi's MDMA for PTSD
"What we find most rewarding is that a portion of this latest batch will be directly used to treat patients in 2025 in Australia, where a growing number of authorized doctors are prescribing Optimi's MDMA for PTSD under the Authorized Prescriber Scheme," said Dane Stevens, CEO of Optimi Health.
"Additionally, our customer feedback is that our MDMA offering is often more cost-effective than other limited options in the market, making it an attractive solution for both patients and healthcare providers. We are excited to be producing affordable and stable inventory in-house under our Drug Establishment Licence. Combined with our capacity to store up to
How to Access Optimi's MDMA Capsules
Entities interested in accessing Optimi's MDMA capsules can contact:
Australia: Mind Medicine Australia
Global Inquiries: sales@optimihealth.ca
About Optimi Health
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, GMP-grade psilocybin and MDMA for clinical research and therapeutic applications. Dedicated to the scalable production of the highest quality natural products, Optimi supports the global psychedelic industry with its state-of-the-art facilities and unparalleled commitment to safety and efficacy. By working closely with healthcare professionals, clinical researchers, and regulatory bodies, Optimi is delivering innovative solutions for mental health care and beyond.
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On Behalf of the Board of Directors
JJ Wilson
Chairman, Optimi Health Corp.
For more information, please contact the Company at:
Telephone: (778) 761-4551
Email: investors@optimihealth.ca
Website: www.optimihealth.ca
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"), including statements pertaining to the study, the results of such study, the benefits of using psilocybin and the potential for follow on studies. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed in the Company's long form prospectus dated February 12, 2021, a copy of which is available on SEDAR+ at www.sedarplus.com. Except as expressly required by applicable law, Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/238810
FAQ
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