Business
Biotech Firm Launches Trial To Study LSD As Treatment For Anxiety
New York-based biopharmaceutical developer MindMed announced last week that it has dosed the first patient in a clinical trial of LSD as a treatment for generalized anxiety disorder.
A New York-based biotech firm has begun a clinical trial to study LSD as a treatment for anxiety, announcing last week that it had administered the psychedelic drug to a patient enrolled in the study for the first time. The research is designed to study the effectiveness of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD) from MindMed, in treating generalized anxiety disorder (GAD).
MindMed is a biopharmaceutical company developing psychedelic therapies to treat mental health disorders. Robert Barrow, the chief executive officer of the company, said that the study is the largest well-controlled clinical trial of LSD ever conducted, adding that the research “represents a major milestone for MindMed and for the many patients suffering from GAD.”
“This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression,” Barrow said in an August 25 statement from the company. “The results of our phase 2b trial will guide the dose selection and development strategy for our pivotal phase 3 clinical trials, as we continue our efforts to bring a new potential treatment to the millions of people living with GAD.”
GAD is a chronic and sometimes debilitating mental health disorder that affects nearly 6% of U.S. adults at some point in their lives. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there are substantial similarities between GAD, major depressive disorder (MDD) and other serious mental health conditions, research into the disorder has yielded little innovation in treatment over the past several decades.
MindMed’s phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. Investigators plan to enroll 200 participants who will receive either a single administration of up to 200 micrograms of MM-120 or a placebo. The primary objective is to determine the reduction in anxiety symptoms 4 weeks after a single administration of MM-120, compared across five groups of study participants. Key secondary objectives of the study, measured up to 12 weeks after the single administration, include assessments of safety and tolerability as well as the quality of life.
The Resurgence of LSD Research
The MindMed study is representative of the recent resurgence in research into psychedelic drugs as treatments for serious mental health conditions. Michael Pollan, a journalist and educator who this summer released “How to Change Your Mind,” a Netflix documentary series based on his 2018 book with the same title, notes that researchers studied LSD as a possible treatment for mental health disorders in the 1950s and ‘60s. The tide of opinion turned against the drug only after people began using it recreationally.
“With a powerful assist from Timothy Leary, the flamboyant Harvard psychology professor, psychedelics had escaped the laboratory, falling into the eager arms of the counterculture,” Pollan wrote in the Wall Street Journal in 2018. “Yet in the decade before that there had been 1,000 published studies of LSD, involving 40,000 experimental subjects, and no fewer than six international conferences devoted to what many in the psychiatric community regarded as a wonder drug.”
In 1968, LSD was criminalized in the United States, largely ending research into the drug for decades. But interest in its value as a psychiatric medicine has rebounded. In July of this year, the American Psychiatric Association issued a statement that encouraged continued research into psychedelics as therapies for serious mental health conditions.
“There is currently inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies,” the APA wrote in a policy position approved by the professional group’s board of trustees. “APA supports continued research and therapeutic discovery into psychedelic agents with the same scientific integrity and regulatory standards applied to other promising therapies in medicine.”
Source: https://hightimes.com/news/biotech-firm-launches-trial-to-study-lsd-as-treatment-for-anxiety/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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