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Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment

May 26, 2023 Published by

Tryp Therapeutics announced on Wednesday that it had “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).”

The Canadian company said in the announcement that the “planned open label study in collaboration with Harvard Medical School/Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms.” 

“Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints,” the announcement said. 

“Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program,” said Jim Gilligan, the chief executive officer of Tryp Therapeutics.

Gilligan told Green Market Report that the “most important thing is a clinical data – to be able to not just assume or hypothesize that we’re going to have a benefit, but to actually demonstrate that we can do something positive for patients.

“We’re looking at things a little bit differently than the big guys, looking at unique areas where we can have first-mover advantage. But we’re judicious in selecting areas where we really think that we’ll have a positive outcome,” Gilligan said.

According to Green Market Report, Gilligan “likened the planned administration of psilocin to the work of anesthesiologists.”

“Using an IV to induce and subsequently awaken the patient from the psychedelic state, the approach might also allow for the use of serotonin antagonists to terminate the psychedelic experience, if necessary,” the outlet said, which noted that TRP-8803 will be “central” to the company’s approach to the therapy.

TRP-8803 is “Tryp’s lead program,” the company says, describing it as “a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.

“The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience,” Tryp said in Wednesday’s announcement. 

The post Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment appeared first on High Times.

Minnesota Adds New Qualifying Conditions to Medical Cannabis Program

December 1, 2022 Published by

The Minnesota Department of Health announced on Wednesday that the agency will add irritable bowel syndrome and obsessive-compulsive disorder to the list of qualifying medical conditions for participation in the state’s medical cannabis program. Under state law, the addition of the new qualifying conditions will become effective beginning on August 1, 2023, according to state officials.

“We are adding the new qualifying conditions to allow patients more therapy options for conditions that can be debilitating,” Minnesota Commissioner of Health Jan Malcolm said in a statement from the health department.

Irritable bowel syndrome (IBS) is a disorder characterized by abdominal pain or discomfort, as well as irregular bowel movements that can result in diarrhea, constipation, both diarrhea and constipation, or bloating. Obsessive-compulsive disorder (OCD) is characterized by recurring, intrusive thoughts that often cause significant emotional distress and anxiety in those living with the disorder. This can lead to repetitive actions or other behaviors that those affected by the condition feel compelled to perform to reduce that distress.

“Research has shown that people who suffer from these conditions can see benefits from using medical cannabis to treat their symptoms,” the health department wrote. 

The new qualifying conditions offer a modest expansion to the state’s medical cannabis program, with an estimated 10% of adults having IBS and 1% meeting the diagnostic criteria for OCD, according to media reports. 

Minnesota Patients Support Adding New Conditions

In public comments on the petitions to add IBS and obsessive-compulsive disorder to Minnesota’s medical marijuana program, a man identified by the initials RH described himself as a working professional with a wife and two daughters.

“My daily life consists of constant fear and stress,” said RH, who noted he has OCD. “Practically the only time I am free of the symptoms is when I am sleeping.”

Under state rules, patients certified for the newly approved qualifying medical conditions will become eligible to enroll in the state’s medical cannabis program on July 1, 2023. Patients will be able to receive medical cannabis from either of the state’s two medical cannabis manufacturers beginning on August 1, 2023. Patients who wish to use medical marijuana to treat any of the state’s qualifying conditions need advance certification from a participating Minnesota healthcare provider.

Opioid Use Disorder Not Approved

The health department declined to approve petitions to add opioid use disorder and gastroparesis, a condition that affects the normal spontaneous movement of the stomach muscles, to Minnesota’s list of conditions that qualify a patient to use medical marijuana. The petition not to add gastroparesis was not approved as a qualifying medical condition because research indicates that cannabis can make the condition worse.

Chris Tholkes, director of the Minnesota Department of Health’s Office of Medical Cannabis, said that the decision not to add opioid use disorder was a difficult one, noting that limited access to existing treatment options, such as methadone clinics, in some geographic areas was one factor that supported approval of the petition.

“We did struggle with this one,” Tholkes told the Star Tribune, adding that medical providers were concerned that “introducing another type of drug could lead to relapse. And in the case of opioid use, relapse can be fatal.”

The decision not to approve opioid use disorder comes as Minnesota and the nation remain in the grips of an opioid overdose death epidemic. Many public comments revealed success in substituting marijuana for opioids.

“After having gone (through) nine years of painkiller use under medical prescription for pain, I know that the use of cannabis would help ease the withdrawal side of it,” said a commenter, identified publicly by the initials TB. “I only use cannabis now.”

When Minnesota lawmakers passed legislation creating the state’s medical cannabis program in 2014, the law included nine conditions that qualified a patient to receive medical cannabis. With the new additions, the list of qualifying conditions will be 19. Current qualifying conditions include chronic pain, post-traumatic stress disorder (PTSD), cancer in certain circumstances, glaucoma, and other serious medical conditions.

More than 39,000 Minnesotans are enrolled in the state’s medical marijuana program, up from 29,000 in 2021. Almost all registered participants are qualified because of intractable or chronic pain, and about a third for PTSD. Muscle spasms, cancer, and sleep apnea are also common qualifying conditions.

New Conditions Considered Annually

Each year, the health department conducts a formal petition process to solicit public input on potential qualifying medical conditions and delivery methods, followed by a public comment period and a review panel.

Under state rules, the commissioner of health is required to annually consider new petitions to add qualifying medical conditions and cannabis delivery methods. No petitions for new delivery methods were submitted this year.

The post Minnesota Adds New Qualifying Conditions to Medical Cannabis Program appeared first on High Times.

Everything you should know about CBD and how it can help you

December 8, 2021 Published by

Having questions, whether you’re an old or new cannabis user, is completely normal. It’s confusing when we talk about hemp, cannabidiol, CBD, cannabis and THC, and how they can all have different effects — especially when they are all linked back to cannabis. Here, we’ll go over everything you should know about CBD, and how […]

The post Everything you should know about CBD and how it can help you appeared first on Latest Cannabis News Today – Headlines, Videos & Stocks.

Decarboxylation: How Cannabis Becomes Psychoactive

November 17, 2020 Published by

Decarboxylation, which is an essential action in enjoying cannabis flowers and edibles, is a process in which carbon dioxide (CO2) leaves a stable molecule and floats off as a gas. Atoms in a molecule can be thought of like billiard balls, with each one having a size, weight, and exact position. As these atoms float away, the substance left behind will become lighter, like a dry towel being lighter than that same towel soaking wet. The idea is that as the CO2 leaves, the weight left behind is reduced.

Decarboxylation typically occurs by heating, but can also be caused by exposure to certain frequencies of light, and certain substances like molecular oxygen in the air.

If the weight of the molecule before and after its decarboxylation is known, then a percent of mass lost in decarboxylation can be calculated. If the CO2 contributes 10 percent of the weight of a molecule, than 90 percent of the mass remains after decarboxylation. This would mean that continuously heating 100 grams of this substance would eventually yield 90 grams of the decarboxylated substance, as the remaining 10 grams represent the weight of CO2 which gassed off.

How Does Decarboxylation Affect Cannabinoids?

Decarboxylation of cannabinoids and cannabis products is very crucial to understanding the power of cannabis as medicine. The cannabis plant only has the ability to produce cannabinoid acids, like THCA, and THC is only created by decarboxylation outside the plant. This decarboxylation is usually done by fire when smoking, or by baking in edibles. Most cannabinoids lose approximately 87.7 percent of their mass upon decarboxylation. This means that if you had 100 grams of crystalline isolate of a cannabinoid acid, such as THCA, after decarboxylation you would have 87.7 grams left of THC.

This is important for people decarboxylating their cannabinoids themselves, such as producers of cannabis-infused edible products and hash oil producer that wish to sell decarboxylated oil. This is also important for advertisers of raw cannabis products such as cured cannabis flower, who must either report the value of the cannabinoid acid directly observed by the testing lab, use the theoretical conversion, or display both.

This labeling issue with raw flower is not as easy as it seems at first glance. Let’s consider a typical example of THC-dominant cannabis. The lab will test the flower and find 26 percent THCA and 3 percent THC. This is because some of the cannabinoid acids produced by the plant are decarboxylated by air and sun before harvesting and curing. The smaller the amount of THC observed directly by the lab typically indicates that the cultivator has submitted fresh cannabis that has been protected from light and exposure. A very high THC content indicates that the cannabis flower is not as fresh and been more exposed.

Now the dispensary has to either advertise two numbers, 26 percent and 3 percent, or advertise one theoretically calculated number, 25.8 percent, or both. Both allow the patient to access the greatest amount of information and be the best informed, while also reducing liability on the cannabis business involved in label making.

Tetrahydrocannabinol (THC) is a well-known cannabinoid for being the primary intoxicant and euphoriant of cannabis. THC is also one of the most practical and safe treatments for neuropathic, chronic, and other types of pain. THC is effective in addressing both the immunological and symptom component of multiple sclerosis (MS).

Despite the fact that THCA is not an intoxicant, it is a powerful medicine. THCA is one of the strongest anti-inflammatory agents in cannabis. Smokers receive very little to none of this cannabinoid, due to its decomposition in the smoking process. THCA is an anti-inflammatory agent, and according to one study, a more powerful neuroprotective agent than THC. THCA is a powerful COX-1 and COX-2 antagonist, similar to aspirin and ibuprofen, but with far less toxicity to the liver.

The effects of THCA and THC reflect the diversity of action on the human body a cannabinoid and its precursor acid can have. The other cannabinoids, CBD, CBG, CBC, and THCV all have acid forms which have distinct effects on human health.

Cannabidiol (CBD) has been shown to be an effective medicine for people suffering from anxiety. What CBD has also been shown to be effective at fighting is breast cancer cells. Many of these studies find that CBD promotes apoptosis, or cell suicide, in breast cancer cells while leaving the healthy cells unaffected.

Cannabidiolic acid (CBDA) is CBD’s acid precursor from raw cannabis flower. CBDA has also been shown to fight human breast cancer, but in a different way. Whereas CBD causes apoptosis in breast cancer cells, CBDA has been shown to slow or stop metastasis of breast cancer cells by arresting their motility, or ability to move throughout the body. This evidence would indicate that a breast cancer patient may want to talk to their doctor about dual CBD/CBDA therapy, taking both decarboxylated CBD and raw CBDA together.

Cannabigerol (CBG) has been shown to have some potent anti-inflammatory properties that are particularly applicable in inflammatory bowel disease (IBS). Additionally, CBG has been shown to have some properties not known among many other cannabinoids, such as an ability to interact with human adrenal receptors and serotonin receptors. Currently, more studies need to be done on cannabigerolic acid (CBGA) in isolation from CBG to get an understanding what, if any, difference there are between the cannabinoid and its precursor acid on human health.

It is important to note that the mass loss is not a conversion rate. Mass loss assumes that all of a substance will decarboxylate and calculates how the mass will change. An accurate answer must account for how much of the cannabinoid will decarboxylate. Studies indicate that 30-70 percent of cannabinoids undergo decarboxylation under standard smoking conditions. This is why our calculations are only a theoretical maximum, and are not a result with the same standing as those directly observed in the plant. This is also why it can be very important to label your theoretical calculations as such, and provide all original values provided by lab results, as a means of reducing liability upon your business.

TELL US, have you ever heard of decarboxylation?

The post Decarboxylation: How Cannabis Becomes Psychoactive appeared first on Cannabis Now.