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Apex Labs Granted Dealer's Licence by Health Canada | ||
By: PR Newswire Association LLC. - 14 Feb 2024 | Back to overview list |
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Authorized to sell psilocybin through Health Canada's Special Access Program. VANCOUVER, BC, Feb. 14, 2024 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin is pleased to announce the approval by Health Canada of APEX's Controlled Drugs and Substances Dealer's Licence (DL). The DL authorizes APEX to sell psilocybin, including APEX-52 microdose and APEX-90 macrodose psilocybin drug products developed in collaboration with licensed dealers in Canada and the United States. The DL authorizes sale under Health Canada's Special Access Program (SAP). APEX's psilocybin products have previously been used to dose Veteran patients both in clinical trials and through the SAP. "Receiving this licence is a significant achievement for APEX alongside our tremendous progress actively dosing patients through our Early Access Program (EAP) and gearing up to launch multiple clinical trials," says Tyler Powell, co-Founder and CEO. "We are grateful to Health Canada for processing APEX's licence application so quickly, signaling the importance of access to controlled and regulated psilocybin." This DL simplifies the supply chain and broadens communication for APEX's psilocybin products by allowing direct sales for the SAP or investigator-led clinical trials. "APEX worked with Health Canada to issue this Dealer's Licence less than four months from application with no observations. Health Canada's responsiveness and clarity made for a simple and straightforward process," says Dr. David Wood, Principal of R-Group Legal, regulatory counsel and strategic advisor to APEX since 2020. "This Dealer's Licence will enable APEX to make access to psilocybin a reality for a greater number of Veterans and Canadians with unmet mental health challenges," adds Mr. Powell. About Apex Labs Ltd. APEX sees Veterans as a patient base with the most severe unmet need, supporting Veteran patients first and expanding to broader global patient communities. PATHFINDER-52 and SUMMIT-90 are statistically powered multi-center randomized, double-blind, placebo-controlled phase 2b studies leveraging APEX-52 microdose and APEX-90 macrodose psilocybin drug assets with patient pre-screening underway. Both have been approved by Health Canada by way of a No Objection Letter (NOL). The APEX Early Access Program (EAP) supports physicians applying through Health Canada's SAP for access to the APEX-90 macrodose psilocybin product for treatment outside of clinical trials where patients are suffering from severe disease states and otherwise meet the criteria for the SAP. Visit apexlabs.com for more information and follow APEX on LinkedIn, Twitter and Instagram Forward-Looking Statement View original content to download multimedia:https://www.prnewswire.com/news-releases/apex-labs-granted-dealers-licence-by-health-canada-302061256.html SOURCE Apex Labs Ltd. |
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