Cannabis Law Report

JANUARY 2, 2023

Here’s Psychedelics Spotlight’s round-up of 2022 The Intro Today, with progress being made on legislative fronts, multiple clinical trials inching closer to FDA approval, and people simply letting go of the misconceptions and fear they’ve felt towards psychedelics, we find ourselves in a situation where the impossible doesn’t feel so impossible (..)

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Clinical Trials Legislation 52

Project CBD

FEBRUARY 28, 2023

11 A separate paper, published in February 2022, analyzed the CBD content of 11 commercially available CBD oils and found that only four (36.4%) matched the amount stated on the label. Available at: [link] Accessed October 17, 2022. Accessed October 17, 2022. February 2, 2022. Accessed October 17, 2022.

CBD 144

CBD Seed-To-Sale Food Access 144

Cannabis Law Report

JULY 28, 2021

This includes First Time in Human (“FTiH”) clinical trials, which are expected to commence in 2022, for the Group’s lead compound OCT461201, a selective cannabinoid receptor type 2 (“CB2”) agonist with initial indications in the areas of post herpetic neuralgia and visceral pain caused by irritable bowel syndrome.

Cannabinoids 81

Cannabinoids Clinical Trials Safety Medicine 81

Cannabis Law Report

NOVEMBER 12, 2021

(Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction, today announced financial results for the first quarter of its fiscal year ending June 30, 2022 and reported recent business highlights. and Arjun Chanmugam, M.D.,

Pharmaceutical 52

Pharmaceutical Clinical Trials Business Research and Development 52

TheAnswerPage

MARCH 11, 2022

In the clinical trials evaluating a purified CBD product (Epidiolex) in epilepsy patients, side effects including sedation, decreased appetite, diarrhea, sleep disturbance, infections, pneumonia, viral infections and weight loss were reported. 308 (2022). ” Kirkland AE, Fadus MC et al. Psych Resear. See the Answer.

Clinical Trials 40

Clinical Trials Epilepsy Events Sleep 40

Veriheal

JUNE 30, 2023

For their analysis, researchers conducted qualitative interviews with 13 individuals who had participated in a psilocybin clinical trial. The 13 individuals were chosen because of their reported improvements in negative drinking behavior following the clinical trial.

Clinical Trials 98

Clinical Trials Research and Development Therapy Policy 98

Cannabis Law Report

SEPTEMBER 13, 2021

(Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan, today announced that it intends to initiate dosing for a Phase 2 trial of MYMD-1’s function in delaying aging early in the fourth quarter of 2021. in the blood. About MyMD Pharmaceuticals, Inc.

Clinical Trials 40

Clinical Trials Pharmaceutical Research and Development Therapy 40

Cannabis Law Report

JULY 18, 2022

Government minister Lord Kamall swerves this completely and diverts to a discussion on necessity for clinical trials, blaming the industry for not funding them. Debate starts with Baroness Meacher asking a question about GP prescribing.

Clinical Trials 52

Clinical Trials Medicine Cannabis Compliance 52

Cannabis Law Report

DECEMBER 20, 2021

First Patient Expected to be Enrolled by Q2 of 2022. Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing product candidates for pain management, CNS disorders and anti-viral indications, signed a clinical trial agreement with Altasciences Company, Inc., BERWYN, Pa.–(BUSINESS

Clinical Trials 40

Clinical Trials Chronic Pain Pharmaceutical Data 40

TheAnswerPage

MAY 23, 2022

Currently, clinical trials are evaluating CBD’s analgesic, neuroprotective, antiepileptic, anxiolytic, antipsychotic, anti-inflammatory, antitumor and anti-hypoxia/ischemia properties. The range of conditions for which CBD has been (or is being) assessed is quite diverse.

Clinical Trials 45

Clinical Trials Conditions CBD 45

Veriheal

MARCH 20, 2023

Smith cited results from clinical trials showing that MDMA holds promise in the treatment of PTSD. Oklahoma In March 2022, Oklahoma state representatives presented a bill that, if approved, would allow clinical trials on psychedelics “in relation to depression, anxiety, opioid use disorder, and dementia.”

Clinical Trials 98

Clinical Trials Therapy Decriminalization Treatment 98

Veriheal

FEBRUARY 9, 2023

A fascinating new clinical trial demonstrates how this psychedelic compound could make people significantly more comfortable while undergoing MRIs or similar procedures. Although many rely on imaging scans to diagnose illnesses and get treatment of various kinds, getting into the enclosed chamber can be stressful. What Is an MRI?

Clinical Trials 98

Clinical Trials Research and Development Data Collective 98

TheAnswerPage

JANUARY 23, 2022

Did the FDA recently approve an investigational new drug (IND) application for a clinical trial investigating a CBD product as an adjunctive treatment for opioid use disorder (OUD)? Pharmacy Times, Jan 6, 2022. The product is a CBD soft gel capsule with 100mg/capsule. FDA Approves IND Application for CBD Product Nantheia ATL5.

Clinical Trials 40

Clinical Trials CBD Treatment 40

Cannabis Law Report

AUGUST 14, 2021

After acquiring the patented Gelpell technology through its acquisition of Satipharm in March, Cann is now looking to resume an internal development program with the aim of securing TGA approval for a Schedule 3 CBD product by the end of 2022.

CBD 105

CBD Clinical Trials Programs Medicine 105

Cannabis Law Report

AUGUST 13, 2021

Development is underway with clinical trials expected to begin in the second half of 2022. “SalA is a great product candidate that magnificently matches the criteria we strive for, with recognized synergies across the atai platform.”.

Conditions 105

Conditions Research and Development Clinical Trials Treatment 105

Cannabis Law Report

AUGUST 17, 2021

Orphan drug designation provides certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials. Conference Call and Webcast Details. Marinus will host a conference call and webcast with slides at 4:30 p.m.

Pharmaceutical 76

Pharmaceutical Clinical Trials Treatment Patients 76

TheAnswerPage

FEBRUARY 8, 2022

No, not according to a 2020 clinical trial which involved the abrupt withdrawal of CBD after four-weeks of use (750 mg twice daily taken orally). Abrupt withdrawal of cannabidiol (CBD): a randomized trial. Do individuals who abruptly stop taking CBD experience physical withdrawal symptoms? Crockett, J., Checketts, D.,

Clinical Trials 45

Clinical Trials Epilepsy CBD 45

Cannabis Law Report

JUNE 17, 2021

Jazz said it expects to generate 65% of 2022 revenues from products that have been launched or acquired since 2019. As part of our continued R&D efforts we also look forward to advancing our PTSD and essential tremor programs, the nabiximols clinical trial program to support a U.S. net leverage by the end of 2022.

Pharmaceutical 83

Pharmaceutical Clinical Trials Therapy Programs 83

Cannabis Law Report

DECEMBER 21, 2021

Within a few months, it had completed the first phase of its clinical trial of DMT in combination with supportive psychotherapy and commenced a phase 2a trial. It’s also initiating phase 2a clinical trial into conditions such as eating disorders and fibromyalgia. 10 Psychedelic Companies To Watch In 2022.

Clinical Trials 52

Clinical Trials Therapy Treatment DEA 52

TheAnswerPage

JUNE 29, 2022

Has CBDV been evaluated as an anti-seizure medication in clinical trials? Yes, GW Pharmaceuticals (the makers of Epidiolex) had trialed CBDV in adult epilepsy, but the study did not meet its primary endpoint of seizure reduction. That trial did not continue.

Clinical Trials 45

Clinical Trials Epilepsy Pharmaceutical Treatment 45

TheAnswerPage

JANUARY 9, 2022

Has CBDV been evaluated as an anti-seizure medication in clinical trials? Yes, GW Pharmaceuticals (the makers of Epidiolex) had trialed CBDV in adult epilepsy, but the study did not meet its primary endpoint of seizure reduction. That trial did not continue.

Clinical Trials 45

Clinical Trials Epilepsy Pharmaceutical Treatment 45

Cannabis Law Report

MAY 31, 2022

The only psychedelic drug that is approved (outside of clinical trials) for psychiatric use—as opposed to anesthesia—through the traditional medical system is Ketamine. 2022 Active FDA Clinical Trials and State-Regulated Systems. Active FDA Regulated Clinical Trials*. On March 5, 2019, the U.S.

Clinical Trials 52

Clinical Trials Legalization Therapy Decriminalization 52

TheAnswerPage

MARCH 29, 2022

Has the National Institute of Drug Abuse (NIDA) recently provided funding for a clinical trial evaluating the efficacy of a CBD product as an opioid-sparing agent for patients with radiculopathic pain? Safety and tolerability of CBD will also be assessed throughout the trial. See the Answer.

Clinical Trials 40

Clinical Trials Safety Medicine Treatment 40

Cannabis Law Report

JULY 25, 2022

million ($650,000) in funding from New Zealand’s Health Research Council (HRC) to conduct a LSD microdosing trial in patients with Major Depressive Disorder (MDD). The state agency grant funding followed the successful completion of a phase 1 clinical trial in 80 healthy participants.

Microdosing 52

Microdosing Clinical Trials Research and Development Data 52

Cannabis Law Report

JULY 13, 2022

VANCOUVER, British Columbia, July 13, 2022 (GLOBE NEWSWIRE) — Optimi Health Corp. ( Their position as therapeutic practitioners, as well as their work in conducting the kind of clinical trials necessary to advance regulatory outcomes for psychedelic medicines, make them ideal partners in alignment with Optimi’s strategic goals.”.

Therapy 52

Therapy Clinical Trials Microdosing Research and Development 52

Cannabis Law Report

NOVEMBER 1, 2021

Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. 135, 2022 (Forthcoming) , Available at SSRN: [link] or [link]. This Essay analyzes the ethical, legal, and social implications of patenting these controversial substances. Harvard Law Review Forum, Vol.

Research and Development 52

Research and Development Law Clinical Trials Therapy 52

Cannabis Law Report

MAY 19, 2022

This is Numinus’ first psilocybin-assisted therapy treatment outside of ongoing clinical trials, and among the first to use of this regulatory mechanism through Health Canada’s Special Access Program (“SAP”), which was amended January 5 th , 2022 to include access to psychedelic compounds on a case-by-case basis.

Therapy 52

Therapy Treatment Clinical Trials Access 52

Cannabis Law Report

NOVEMBER 12, 2021

As set out above, the Company understands that Brown Shipley is unable to exercise its security over the Pledged Shares until 1 July 2022 and has been informed that KCP are in discussions with Brown Shipley about removing the Pledged Shares from the Charge and will update the market accordingly. A PDMR form is set out below. 198,466,493.

Cannabinoids 98

Cannabinoids Clinical Trials Research and Development Pharmaceutical 98

Cannabis Law Report

FEBRUARY 9, 2022

Cybin plans to submit a clinical trial application for a pilot study of CYB004 in the second quarter of calendar year 2022 and expects to initiate the pilot study in the third quarter of calendar year 2022.

Treatment 52

Treatment Clinical Trials Research and Development 52

TheAnswerPage

MAY 25, 2022

The results of recent clinical trials indicate that Cannabidiol (CBD) reduces seizures among patients with refractory epilepsies of various etiologies. Most of these clinical studies report efficacy over short time periods (.

Clinical Trials 40

Clinical Trials Epilepsy Treatment CBD 40

TheAnswerPage

FEBRUARY 23, 2022

Some clinical studies have evaluated the safety and efficacy of cannabinoid-based medicines for the treatment of autism spectrum disorder (ASD). What are the common adverse events noted in clinical trials examining the efficacy of cannabinoids for ASD?

Clinical Trials 40

Clinical Trials Events Therapy Sleep 40

Cannabis Law Report

JANUARY 6, 2022

(Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announces that management will present a company overview at the H.C. Wainwright BioConnect Virtual Conference being held January 10-13, 2022. Anebulo Pharmaceuticals, Inc.

Pharmaceutical 52

Pharmaceutical Clinical Trials Cannabinoids Business 52

Cannabis Law Report

JUNE 19, 2022

Partnership will focus on the collection and analysis of digital biomarkers to identify signs of response and relapse in upcoming Phase 2 clinical trials. June 14, 2022 02:00 AM Eastern Daylight Time. However, we need rigorous clinical trials to ensure that this promise is realised.

Clinical Trials 52

Clinical Trials Patients Research and Development Treatment 52

Cannabis Law Report

FEBRUARY 24, 2022

Each request is decided on a patient-by-patient basis and approval is usually only given to drugs with successful phase II or phase II clinical trials. The 2013 amendment cut off access to SAP for psychedelic drugs like MDMA and psilocybin, leaving clinical trials as the only vehicle for patients to access psychedelic services.

Therapy 52

Therapy Access Clinical Trials Treatment 52

Cannabis Law Report

APRIL 13, 2022

Apr 12, 2022, 07:00 ET. Complementary businesses combine to create a preeminent North American platform with operations spanning 13 wellness clinics, four research sites and one bioanalytical laboratory. Transaction expected to close in June 2022 , following anticipated shareholder approval. Numinus Wellness Inc. .

Clinical Trials 52

Clinical Trials Research and Development Therapy Treatment 52

Veriheal

MAY 16, 2022

At the current time, researchers are busy carrying out a small-scale Phase I clinical trial into ketamine for PD. The study’s outcome will be revealed during a medical congress presentation no later than June 2022.

Research and Development 19

Research and Development Treatment Clinical Trials Patients 19

Cannabis Law Report

SEPTEMBER 22, 2021

Accelerated timelines to clinical trials and expansion of drug development pipeline. Phase 1 clinical trials are scheduled for Q3 2022 with Phase 2 trials expected in Q2 2023. Exclusive licensing agreement with leading global cannabis company (“Canopy Growth”).

Pharmaceutical 52

Pharmaceutical Clinical Trials Research and Development Cannabinoids 52