{"id":18465,"date":"2022-01-25T08:49:20","date_gmt":"2022-01-25T16:49:20","guid":{"rendered":"https:\/\/marketdepth.com\/?p=18465"},"modified":"2022-01-25T08:49:22","modified_gmt":"2022-01-25T16:49:22","slug":"fda-clears-the-way-for-first-commercial-study-of-lsd-in-40-years","status":"publish","type":"post","link":"https:\/\/marketdepth.com\/fda-clears-the-way-for-first-commercial-study-of-lsd-in-40-years\/","title":{"rendered":"FDA Clears the Way for First Commercial Study of LSD in 40 Years"},"content":{"rendered":"\n

Mind Medicine Inc. (NASDAQ: MNMD)<\/strong> has seen its Investigational New Drug application cleared <\/a>by the FDA, opening the door for the company\u2019s Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder to proceed.<\/p>\n\n\n\n

Up Premarket<\/h5>\n\n\n\n

Shares of Mind Medicine Inc. (NASDAQ: MNMD) gained over 8% during the pre-market session.<\/p>\n\n\n\n

FDA Clearance<\/h5>\n\n\n\n

MM-120 is the company\u2019s proprietary drug candidate and pharmacologically optimized form of LSD being developed for various brain-based disorders. The FDA clearance comes after the company satisfied requests for additional information related to the participant monitoring protocol in the upcoming study.<\/p>\n\n\n\n

“FDA clearance of our Phase 2b clinical trials represents a major milestone, for MindMed and for the industry as a whole.”<\/p>Robert Barrow, Chief Executive Officer and Director of MindMed<\/cite><\/blockquote>\n\n\n\n

The company is now collaborating with study investigators as well as clinical trial sites in an effort to prepare for enrollment in the early stages of 2022. A total of 200 participants will receive a single administration of up to 200 \u00b5g of MM-120 or a placebo control, with the reduction in anxiety symptoms a primary objective of the study.<\/p>\n\n\n\n

“This trial, the first commercial study of LSD in more than 40 years, builds on productive discussions with FDA and provides an opportunity to explore improvements in anxiety symptoms following a single administration of MM-120. Further, the results of this trial will guide the dose selection and development strategy for our pivotal Phase 3 clinical trials, as well as deepen our scientific understanding of the clinical effects of MM-120 and its underlying mechanisms of action.”<\/p> Robert Barrow, Chief Executive Officer and Director of MindMed <\/cite><\/blockquote>\n","protected":false},"excerpt":{"rendered":"Mind Medicine Inc. (NASDAQ: MNMD) has seen its Investigational New Drug application cleared by the FDA, opening the door for the company\u2019s Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder to proceed. Up Premarket Shares of Mind Medicine Inc. (NASDAQ: MNMD) gained over 8% during the pre-market session. FDA Clearance… View Article<\/a>","protected":false},"author":3,"featured_media":18024,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":0,"footnotes":""},"categories":[9,10,31,17,8,11,16],"tags":[],"acf":[],"yoast_head":"\nFDA Clears the Way for First Commercial Study of LSD in 40 Years - MarketDepth<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/marketdepth.com\/fda-clears-the-way-for-first-commercial-study-of-lsd-in-40-years\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Clears the Way for First Commercial Study of LSD in 40 Years - MarketDepth\" \/>\n<meta property=\"og:description\" content=\"Mind Medicine Inc. (NASDAQ: MNMD) has seen its Investigational New Drug application cleared by the FDA, opening the door for the company\u2019s Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder to proceed. Up Premarket Shares of Mind Medicine Inc. (NASDAQ: MNMD) gained over 8% during the pre-market session. FDA Clearance... 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