[vc_row full_width=”stretch_row” content_placement=”middle” background_color=”custom” custom_background_color=”#f5ede4″ lg_spacing=”padding_top:50;padding_bottom:50″][vc_column width=”1/12″ background_color=”custom”][/vc_column][vc_column width=”10/12″][tm_spacer size=”lg:20″][tm_heading tag=”h2″ custom_google_font=”” align=”center” text_color=”primary” el_class=”heading-medium” text=”Program: EMD-003″ font_size=”lg:36″][tm_spacer size=”lg:20″][tm_heading tag=”h5″ custom_google_font=”” align=”center” text_color=”secondary” el_class=”heading-medium” text=”Target indication: Irritable Bowel Syndrome” font_size=”lg:20″][tm_spacer size=”lg:20″][tm_heading tag=”h2″ custom_google_font=”” align=”center” text_color=”custom” custom_text_color=”#222222″ text=”Developing a new cannabinoid formulation for stress, anxiety and depression.” font_size=”lg:30″][/vc_column][vc_column width=”1/12″][/vc_column][/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”top” background_color=”custom” custom_background_color=”#f5ede4″ lg_spacing=”margin_right:-50;margin_left:-50;padding_bottom:100″ el_id=”custom-accoridions-container” el_class=”custom-accoridions-container”][vc_column width=”1/4″ lg_spacing=”padding_right:0″][tm_button_group lg_spacing=”padding_right:0″][tm_button style=”modern” full_wide=”1″ icon_align=”left” action=”smooth_scroll” icon_type=”fontawesome5″ icon_fontawesome5=”far fa-arrow-alt-circle-right” button=”url:%23the-situation|title:The%20Situation||” rounded=”5px”][tm_button style=”modern” full_wide=”1″ icon_align=”left” action=”smooth_scroll” icon_type=”fontawesome5″ icon_fontawesome5=”far fa-arrow-alt-circle-right” button=”url:%23the-problem|title:The%20Problem||” rounded=”5px”][tm_button style=”modern” full_wide=”1″ icon_align=”left” action=”smooth_scroll” icon_type=”fontawesome5″ icon_fontawesome5=”far fa-arrow-alt-circle-right” button=”url:%23the-solution|title:The%20Solution||” rounded=”5px”][tm_button style=”modern” full_wide=”1″ icon_align=”left” action=”smooth_scroll” icon_type=”fontawesome5″ icon_fontawesome5=”far fa-arrow-alt-circle-right” button=”url:%23our-progress|title:Our%20Progress||” rounded=”5px”][tm_button style=”modern” full_wide=”1″ icon_align=”left” action=”smooth_scroll” icon_type=”fontawesome5″ icon_fontawesome5=”far fa-arrow-alt-circle-right” button=”url:%23key-takeaways|title:Key%20Takeaways||” rounded=”5px”][/tm_button_group][/vc_column][vc_column width=”3/4″][vc_tta_accordion style=”modern” shape=”square” gap=”30″ c_position=”right” active_section=”1″ collapsible_all=”true” el_id=”custom-accoridions” el_class=”custom-accoridions”][vc_tta_section title=”The situation.” tab_id=”the-situation”][vc_row_inner][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”Mental health is a growing global health challenge and notoriously difficult to treat. In Australia, mental health is often cited as the most prevalent chronic health condition, affecting 4.8 million people. That’s over 20% of all Australians.” font_size=”lg:16″][/vc_column_inner][/vc_row_inner][vc_row_inner el_class=”heading-with-border-line” lg_spacing=”margin_top:30;margin_bottom:50″][vc_column_inner][tm_heading tag=”h5″ custom_google_font=”” text_color=”secondary” el_class=”heading-extra-small” text=”4.3 million Australians received mental health-related prescriptions (2018-19).” letter_spacing=”3px”][tm_heading tag=”h5″ custom_google_font=”” text_color=”secondary” el_class=”heading-extra-small” text=”This included 27 million antidepressant prescriptions.” letter_spacing=”3px”][tm_heading tag=”h5″ custom_google_font=”” text_color=”secondary” el_class=”heading-extra-small” text=”Many medications can cause sedation, withdrawal and memory impairment.” letter_spacing=”3px”][tm_heading tag=”h5″ custom_google_font=”” text_color=”secondary” el_class=”heading-extra-small” text=”Over 50% of patients at Emerald Clinics, our clinic network, present with moderate to severe depression, anxiety or stress.” letter_spacing=”3px”][/vc_column_inner][/vc_row_inner][vc_row_inner el_class=”heading-with-border-line”][vc_column_inner][tm_image action=”popup” align=”center” image=”3818″][/vc_column_inner][/vc_row_inner][vc_row_inner el_class=”heading-with-border-line”][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”Registered medications reach many more patients and yet roughly one-third of conventional medications for mental health are thought to be ineffective in treating the symptoms of stress, anxiety and depression.” font_size=”lg:16″ css=”.vc_custom_1614816993959{padding-top: 30px !important;}”][/vc_column_inner][/vc_row_inner][/vc_tta_section][vc_tta_section title=”The problem.” tab_id=”the-problem”][vc_row_inner][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”While there has long been strong anecdotal evidence to suggest low-dose medicinal cannabis could be an effective treatment for the symptoms of stress, anxiety and depression, clinical studies have been patchy and inconclusive.” font_size=”lg:16″][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large brand-heading” text=”The first problem: The need for solid clinical evidence
In December 2020 the TGA ruled that low-dose (<150mg) CBD could be registered as a schedule 3 ‘pharmacist only’ medication.
However, the TGA quite rightly stressed that all applications would require high-quality dose-, product- and indication-specific clinical evidence for registration.
The second problem: Making a low-dose cannabinoid palatable
Our experience at Emerald Clinics highlighted a second issue. Even with sufficient evidence to gain regulatory approval for a low-dose cannabinoid treatment for mental health issues, patients were frustrated with traditional oils and droppers.
Patients really want a more convenient, palatable dose form.” font_size=”lg:16″][/vc_column_inner][/vc_row_inner][/vc_tta_section][vc_tta_section title=”The solution.” tab_id=”the-solution”][vc_row_inner][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”With our CBD experience and a significant patient cohort experiencing mental health issues, we saw a unique opportunity to register our own low-dose cannabinoid medicine for stress, anxiety and depression.
After conducting an in-depth analysis of our own data, published literature and patent landscape, we filed unique IP covering the use of specific doses of CBD covering the TGA’s 150mg threshold for a set of medical indications and patient cohorts.” font_size=”lg:16″][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large quote-text” text=”“Because we take our time with every patient and use our dynamic real-world evidence platform to gain invaluable clinical insights, we’re able to focus on achieving the best outcomes for each individual patient.“
“It also means we have a high-quality, one-of-a-kind clinical data asset that provides invaluable real-world evidence and intellectual property that can accelerate drug registration programs. Our registration study of EMD003 shows this model in action.”
Dr Michael Winlo, Managing Director, Emyria” font_size=”lg:16″ css=”.vc_custom_1614223716734{margin-top: 30px !important;margin-bottom: 30px !important;padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 30px !important;background-color: #f5ede4 !important;}”][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”Having prescribed a broad range of products in different dose forms, our Emerald Clinics doctors have a wealth of comparison data to draw on. This includes data generated by prescribing EMD-003 to over 170 patients in a convenient capsule form that patients prefer. The capsule uses special slow-release absorption technology, which enhances efficacy.
Once we have secured registration with our final evidence package (expected to be submitted in the second half of 2021), EMD-003 will help tackle the growing global concern of mental health and, in particular, the symptoms of anxiety, depression and stress.
In addition to our TGA-registration plan, we have designed our EMD-003 registration studies to meet the requirements of other global regulatory bodies. This gives us the ability to subsequently apply for EMD-003 pharmaceutical registration in other major markets and jurisdictions.” font_size=”lg:16″][/vc_column_inner][/vc_row_inner][vc_row_inner el_class=”heading-with-border-line” lg_spacing=”margin_top:15;margin_bottom:30″][vc_column_inner][tm_image align=”center” image=”3699″][/vc_column_inner][/vc_row_inner][/vc_tta_section][vc_tta_section title=”Our progress.” tab_id=”our-progress”][vc_row_inner el_class=”heading-with-border-line”][vc_column_inner][tm_image action=”popup” align=”center” image=”3773″][/vc_column_inner][/vc_row_inner][/vc_tta_section][vc_tta_section title=”Key takeaways.” tab_id=”key-takeaways”][vc_row_inner][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”Our independent clinics and proprietary data management tech have enabled us to provide novel treatment options and hope for patients who have exhausted all other options.” font_size=”lg:16″][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”It’s a model that allows us to provide truly personalised care based on deeper patient knowledge and insights. This deep care generates a one-of-a-kind data asset that we use to expedite the development and registration of new treatments and therapies, or find new ways to use conventional ones.” font_size=”lg:16″][/vc_column_inner][/vc_row_inner][vc_row_inner el_class=”heading-with-border-line” lg_spacing=”margin_top:30;margin_bottom:30″][vc_column_inner][tm_image action=”popup” align=”center” image=”3819″][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][tm_heading tag=”p” custom_google_font=”” text_color=”secondary” el_class=”text-large” text=”EMD-003 is a case in point for our approach. It proves that our repeatable model generates the clinical-trials-quality data and real-world evidence regulators need to approve novel treatments, making them available to doctors and patients across mainstream healthcare systems worldwide.” font_size=”lg:16″][/vc_column_inner][/vc_row_inner][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row][vc_row full_width=”stretch_row” content_placement=”middle” background_color=”custom” custom_background_color=”#7d1748″ lg_spacing=”padding_top:100;padding_bottom:100″][vc_column][vc_row_inner][vc_column_inner width=”1/12″][/vc_column_inner][vc_column_inner width=”10/12″][tm_heading tag=”h4″ custom_google_font=”” text_transform=”uppercase” align=”center” text_color=”custom” custom_text_color=”#ffffff” el_class=”leading-text” font_size=”lg:14″ letter_spacing=”3px”][tm_spacer size=”lg:20″][tm_heading tag=”h2″ custom_google_font=”” align=”center” text_color=”primary” el_class=”heading-medium” text=”Tap into our clinical care, real-world data and registration expertise.” font_size=”lg:36″][/vc_column_inner][vc_column_inner width=”1/12″][/vc_column_inner][/vc_row_inner][tm_button_group align=”center” lg_spacing=”margin_top:30″][tm_button el_class=”beige-hover” button=”url:https%3A%2F%2Femyria.com%2Fcontact-us%2F|title:Talk%20to%20our%20team||”][/tm_button_group][/vc_column][/vc_row]