Remove 2014 Remove Clinical Trials Remove Safety
article thumbnail

MDMA Failed to Receive FDA Approval: What Happens Next?

Veriheal

Drug company Lykos Therapeutics, which had filed the new drug application for MDMA therapy , was informed by the US Food and Drug Administration (FDA) that the data submitted was insufficient to receive approval, requesting that the company conduct an additional Phase 3 trial to further test the safety and efficacy of the drug.

article thumbnail

Wake Network Retains CRO Santé Cannabis to Conduct Clinical Trials in Psilocybin Therapies

Cannabis Law Report

Both parties to this new relationship are committed to excellence in clinical research and patient access to psychedelic medicine with a focus on naturally derived psilocybin. This engagement will build on the strong foundation on Santé, having treated more than 10,000 patients since 2014 under a real-world data protocol.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Oxford Cannabinoid Technologies Holdings plc – Pre-Close Trading Update; US OTC QB Market Application & Notice of 2021 Final Results

Cannabis Law Report

At the end of the programme, Evotec will provide the Company with a submission-ready regulatory document which will be used for submissions to regulatory agencies, as well as drug-batch approved and ready for First Time in Human clinical trials. Since the year-end, the £2.6 A further announcement will be made following confirmation.

article thumbnail

MAPS: Regulatory Publishing Specialist – Remote Position Regulatory Affairs · Any City, Any State, California

Cannabis Law Report

Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. 2-3 years of relevant experience in clinical trials, research methods, or statistical design and analysis. Experience working for a clinical study Sponsor.

article thumbnail

Press Release: MAPS is Granted Innovation Passport in United Kingdom for MDMA as an Adjunct to Therapy for PTSD

Cannabis Law Report

The Innovation Passport does not reduce the burden of demonstrating that a treatment may be safe and effective, but does provide research organizers with expert advice, patient input, and collaboration throughout the clinical trial design and development process through a product-specific Target Development Profile.

article thumbnail

Press Release: MAPS Places Fully Validated, Multi-Kilogram Synthesis of MDMA in the Public Domain?

Cannabis Law Report

The availability of larger quantities of cGMP-compliant MDMA will facilitate ongoing clinical trials and provide for future therapeutic use following anticipated regulatory approvals. in each of the four validation trials with an acceptable yield, which is a noteworthy accomplishment. April 5, 2022.

article thumbnail

MAPS Is 36 Years Old – Doblin Provides Precis Timeline of the Organization

Cannabis Law Report

This year, we are completing the second Phase 3 clinical trial of MDMA-assisted therapy for PTSD , the final stage prior to requesting FDA approval for a new prescription treatment to help heal trauma. MAPS completed the first Phase 1 safety study with MDMA and resumed working on a protocol for anxiety associated with cancer.