Emyria Limited

Emyria’s Specialist Psychiatrist Granted Authorised Prescriber Status in MDMA-Assisted Therapy for PTSD

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) focused on delivering and developing new treatments for mental health and select neurological conditions, is pleased to announce the Company’s distinguished psychiatry specialist has been granted "Authorised Prescriber" status by the Therapeutic Goods Administration (TGA). The authorisation enables the prescribing of MDMA according to an ethics committee endorsed care model developed by Emyria 1 and within the strict regulatory framework established by the TGA for the treatment of Post-Traumatic Stress Disorder (PTSD). 2


HIGHLIGHTS

  • Emyria's key specialist has been granted "Authorised Prescriber" approval from the TGA
  • Authorisation reflects Emyria's dedication to mental health care under strict regulatory, ethical, and safety standards
  • Achieving Authorised Prescriber status for MDMA-assisted therapy in PTSD care signifies a strategic step towards expanding Emyria's service offerings
Dr. Michael Winlo, CEO and MD, commented: "This authorisation demonstrates Emyria’s commitment to evaluating emerging treatments within the strict regulatory framework set by the TGA.

Emyria’s expertise and track record in innovative clinical service development and Real-World Data capture uniquely positions us to evaluate new therapeutic options in a safe and responsible way. Achieving Authorised Prescriber status showcases Emyria's capacity for impactful and responsible growth in the field of mental health treatments."

Initial focus on Post-Traumatic Stress Disorder (PTSD):

PTSD affects approximately 1 million Australians 3. With up to one third of patients failing to benefit from conventional therapies, there is a growing need for more effective treatments. MDMA-assisted therapy (MDMA-AT) is being evaluated as a treatment for PTSD and multiple Phase 3 clinical trials have been conducted by MAPS in the USA. 4, 5

Emyria is currently studying MDMA-AT therapy for PTSD in an ethics-approved clinical trial (EMDMA-001). Experience with the trial has informed a unique delivery model for Emyria’s Authorised Prescriber program.

Authorised Prescribers must adhere to stringent TGA guidelines to ensure the highest level of patient care and safety. The authorisation is part of Emyria’s broader commitment to increasing options for mental health through robust clinical research and ethical practice.

A presentation explaining how the Authorised Prescriber milestone fits into Emyria’s broader strategy will be available on the ASX platform.

Risks associated with the use of MDMA

All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding. Adverse effects of MDMA include high blood pressure, increased pulse rate, faintness, and panic attacks, and in some rare cases it can cause loss of consciousness or trigger seizures. Other side effects include involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint stiffness. These effects are unlikely at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately managed in a controlled environment with direct medical supervision.


Click here for the full ASX Release

This article includes content from Emyria Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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BOTOX® Cosmetic  Continues its Mission of Empowering Entrepreneurs Through "The Confidence Project"

BOTOX® Cosmetic Continues its Mission of Empowering Entrepreneurs Through "The Confidence Project"

  • BOTOX ® Cosmetic Will Provide 250 Entrepreneurs with Access to New Resources and Opportunities and Will Award 20 Grants Worth $20,000 Each to Support Business Goals.
  • By 2030, BOTOX ® Cosmetic Pledges to Empower 50,000 Entrepreneurs, Helping to Close the Confidence Gap.

- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced BOTOX ® Cosmetic's continued commitment to closing the Confidence Gap with the introduction of The Confidence Project: Empowering Women Entrepreneurs . The one & only BOTOX ® Cosmetic invites business owners to apply for this year's program starting today through May 9, 2025 at 11:59pm PT .

BOTOX® Cosmetic (onabotulinumtoxinA) Continues its Mission of Empowering Entrepreneurs Through

Women entrepreneurs continue to break barriers in the business world, with increasing efforts to close the Confidence Gap. When women founders are supported by mentors and have access to capital, they become agents of change. Seventy-one percent of businesswomen said their mentor was influential in their career advancement, with many using their income to uplift their families and community. 1

Since 2023, BOTOX ® Cosmetic has provided a total of $1 million dollars in grant funding across more than 40 founders, along with coaching and networking opportunities. This year, BOTOX ® Cosmetic is expanding to reach more founders by providing 250 entrepreneurs with access to The Confidence Project. Through a partnership with Hello Alice, an online platform that helps businesses launch and grow, each of the 250 entrepreneurs will participate in an intensive "Boostcamp" program, which will provide participants with skill-building, mentorship resources, and exclusive networking opportunities. After completing the course, they will leverage their newfound skills to pitch their business to a panel of aesthetic entrepreneurs, as well as key business leaders from Allergan Aesthetics and Hello Alice, for a chance to receive one of 20 $20,000 grants from BOTOX ® Cosmetic.

"BOTOX ® Cosmetic is committed to being a catalyst for confidence, whether that be by pursuing education, aesthetic treatment, or your entrepreneurial goals. Through The Confidence Project, we pledge to continue to uplift founders who've invested so much in their businesses," said Nicole Katz , Vice President, Customer Engagement and Corporate Affairs at Allergan Aesthetics. "We know when women have access to resources and capital, there's no limit to what they can achieve. We look forward to getting to know this year's cohort of founders and how they found the confidence to pursue their dreams."

"Our mission at Hello Alice is to help entrepreneurs access the funding, mentorship, and resources they need to succeed. BOTOX ® Cosmetic's The Confidence Project provides a powerful opportunity for women entrepreneurs to scale their businesses and create lasting change," said Elizabeth Gore , Co-Founder and President of Hello Alice. "Our partnership with BOTOX ® Cosmetic aims to foster long-term growth, confidence, and leadership for future generations of women in business, by investing in their success today."

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact . Applicants must agree to the official rules of the grant program and submissions must be received by May 9, 2025 , at 11:59pm PT . The 250 women entrepreneurs selected to participate in the Hello Alice Boostcamp will be announced in July, and the 20 grant recipients will be announced in October 2025 .

For more information on The Confidence Project, visit www.botoxcosmetic.com/realimpact and follow @botoxcosmetic on Instagram and YouTube .

About Allergan Aesthetics  
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com .

About AbbVie  
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn   ,   Facebook , Instagram , X (formerly Twitter) , and YouTube .

Approved Uses  
BOTOX ® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.

IMPORTANT SAFETY INFORMATION

BOTOX ® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX ® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX ® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, and/or platysma bands.

BOTOX ® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX ® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX ® Cosmetic if you are allergic to any of the ingredients in BOTOX ® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing, from standard doses of BOTOX ® Cosmetic.

Tell your doctor about all your medical conditions, including surgery or plans to have surgery on your face, trouble raising your eyebrows, drooping eyelids, any other abnormal facial change, are pregnant or plan to become pregnant (it is not known if BOTOX ® Cosmetic can harm your unborn baby), or are breastfeeding or plan to (it is not known if BOTOX ® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, or Letybo in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; or take aspirin-like products or blood thinners.

Other side effects of BOTOX ® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes.

For more information, refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan Aesthetics at 1-800-678-1605.

Please see BOTOX ® Cosmetic full Prescribing Information , including Boxed Warning and Medication Guide .

References:

  1. Barbara Kurshan. Forbes.com. Purpose-Driven Women: Unleash Your Potential Through Mentorship. 2023 https://www.forbes.com/sites/barbarakurshan/2023/06/13/purpose-driven-women-unleash-your-potential-through-mentorship/

© 2025 AbbVie. All rights reserved. BOTOX Cosmetic and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates.

Contacts:

Investors:
Liz Shea
Liz.Shea@AbbVie.com
(847) 935-2211

Media:
Ember Garrett
Ember.Garrett@allergan.com
(714) 246-3525

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact.

Allergan Aesthetics (PRNewsfoto/AbbVie)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/botox-cosmetic-onabotulinumtoxina-continues-its-mission-of-empowering-entrepreneurs-through-the-confidence-project-302444121.html

SOURCE AbbVie

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NORTH CHICAGO, Ill. , April 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). 1 This comes after the European Commission recently granted marketing authorization of RINVOQ for the treatment of GCA in adult patients.

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- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025 .

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