Prescription ayahuasca could come in the next decade as Canadian company sets sights on FDA approval

A medical version of the popular hippie brew ayahuasca could become available to Americans within a decade.

Filament Health, a Canadian psychedelics company, has developed a medicinal form of the powerful psychedelics that can be taken orally as a pill. The company hopes to put the medical grade through an FDA trial in 2023.

Ayahuasca has been touted as an alternative treatment for post-traumatic stress disorder (PTSD) and depression after it gained popularity with the support of celebrities such as Joe Rogan and Green Bay Packers quarterback Aaron Rodgers.

But Americans currently have to travel to Central and South America for expensive retreats and religious experiences with the potent brew.

However, the therapeutic benefits are mainly anecdotal, and a growing body of evidence shows that the drug also carries the risk of long-term mental health effects.

Brewed Ayahuasca Elixir Including Chacruna Bark Is Depicted On A Traditional Shaman'S Drum.

Ayahuasca is a brownish-reddish drink made by boiling together stems of the eponymous vine and leaves of the chacruna shrub (pictured)

Ayahuasca contains the compound N,N-Dymethyltriptamine (DMT), one of the world’s most powerful hallucinogens.

Like LSD and psilocybin, DMT has demonstrated its ability to increase connectivity between various brain networks that are hampered by depression and trauma.

The ayahuasca brew is made from the boiling Amazon vine Banisteriopsis caapi, which contains the DMT, and the chacruna shrub.

The brew is usually administered by a shaman, who acts as a guide during the journey.

There is no standard ayahuasca recipe. Different cultures and shamans will make it different based on their tradition. This means there is no uniform dose of DMT, creating a variable experience for users.

Filament Health, which focuses on developing botanical psychedelics to treat mental illness, has developed a medicinal form of ayahuasca that is likely to undergo regulatory-approved trial in 2023.

According to Ben Lightburn, CEO of Filament Health, it could be available for prescription use in North America within a decade.

“Drug development is long and expensive… a typical drug development course takes a minimum of five to seven years, and we are now only in the very early stages,” said Mr Lightburn. told the Toronto star.

Filament licenses its therapies to researchers and institutions that want to study the applications of psychedelics in mental health care. Several institutions have begun studying psilocybin produced by Filament.

The same process must take place before medical grade ayahuasca can be studied in a clinical trial.

Researchers looking to study banned substances like DMT also have to jump through a number of bureaucratic hoops. Because DMT is a schedule 1 substance, meaning it is not considered to have any medical benefit, researchers must provide the DEA with comprehensive ingredient lists, surveillance protocol, and storage plans.

Researchers interested in studying DMT must submit an Investigational New Drug (IND) application to the appropriate department within the Food and Drug Administration, which may decline. In that case, a project may be clinically suspended indefinitely

Even if the experiment is approved and its medicinal value is discovered, there is no obvious path to assigning the drug a new classification, making its introduction to the US market even more obscure.

Filament Health specializes in developing psychedelic drugs for the treatment of mental health problems, such as major depression and opioid addiction.

The medicinal ayahuasca is just the latest development in a wave of research into the therapeutic properties of similar drugs, such as psilocybin, the psychoactive ingredient in magic mushrooms.

The Mental Side Effects That People Experienced Are Listed Above.  Hearing Or Seeing Things Or Feeling Disconnected Were The Most Common

The mental side effects that people experienced are listed above. Hearing or seeing things or feeling disconnected were the most common

Seven Out Of Ten People Who Used Ayahuasca Said They Had A Physical Side Effect.  The Most Common Was Vomiting, But This Is Considered Normal When Drinking And Is Part Of 'Cleansing'

Seven out of ten people who used ayahuasca said they had a physical side effect. The most common was vomiting, but this is considered normal when drinking and is part of ‘cleansing’

What is Ayahuasca?

Ayahuasca is a hallucinogenic drink that is illegal in the US and UK but widely used by tribal societies in the Amazon Basin.

Shamans consider ayahuasca to be a “wisdom plant” that gives access to the spiritual world and was recognized as such by the government of Peru in 2008.

It can cause hallucinations similar to the effects of LSD or magic mushrooms, according to Talk to Frank. They last two hours and are “mostly enjoyable,” but can cause panic and horrifying flashbacks, the website says.

The negative emotional effects of using ayahuasca can last for days and make it especially dangerous for people with mental health problems.

It can also increase blood pressure and heart rate and may be harmful to people with pre-existing heart disease.

The ayahuasca plant is typically the star of the psychedelic experience. The compound increases connectivity between different brain networks and increases synaptic plasticity.

It evokes powerful hallucinations and distorts one’s view of reality.

The chacruna bush, meanwhile, kickstarts the DMT in the elixir.

The body’s natural enzymes break down the psychoactive effects in the ayahuasca plant, so shamans add the shrub’s extracts.

Chacruna shrub is rich in a compound known as a ‘monoamine oxidase inhibitor’ (MAOI), which stops the body’s enzymes from working. South American shamans have used the shrub to develop several ayahuasca recipes, and Filament wanted to honor the traditional base of the brew.

DMT is generally synthesized on its own, but Filament Health scientists sourced one of the traditional preparations, including the chacruna shrub, to extract the medical grade ayahuasca.

Mr Lightburn said: ‘We have a hypothesis that the reason ayahuasca might work well for certain indications has to do with the fact that it’s not just DMT, but the combination.’

Filament has already launched clinical trials of another psychedelic treatment for major depression. The PEX010 capsule consists of the compound that gives magic mushrooms its psychedelic effects, psilocybin.

PEX010 is currently being used in clinical trials approved by health regulators in both Canada and the US.

The company has also received several patents from the Canadian Intellectual Property Office and the United States Patent and Trademark Office for their process of extracting natural psilocybin from plants and manipulating it into a useful medical treatment.

Despite its illegal status in the US, ayahuasca has gained a high-profile following, including fans like Miley Cyrus and Joe Rogan.

Miley Cyrus said in a 2020 interview with Rolling Stone magazine that she “loved” the drug and immediately saw snakes from it.

Joe Rogan is a big proponent of DMT – the active ingredient used in ayahuasca – and regularly shares his experiences on his podcast.

Booze has also been blamed for Packers quarterback Aaron Rodgers’ struggles, with his team losing five games this season.

Mr. Rodgers, a four-time MVP winner with two consecutive wins, credited his on-field success to transformative journeys with ayahuasca. IS THIS ALL UP TO DATE NOW?

Ayahuasca has been used for spiritual purposes by the indigenous peoples of the Amazon Basin for at least a century, mostly in religious rituals.

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Merry C. Vega is a highly respected and accomplished news author. She began her career as a journalist, covering local news for a small-town newspaper. She quickly gained a reputation for her thorough reporting and ability to uncover the truth.

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