Canadian firms in line to supply psychedelics for Australia’s Authorized Prescriber Scheme
PharmAla Biotech – January 29, 2024
Australia is ramping up its Authorized Prescriber Scheme for psychedelic medicines, presenting a significant opportunity for Canadian biotechnology firms to supply it with safe and standardized good manufacturing practice-grade substances.
The Australian organization responsible for the regulation of therapeutic goods including drugs and medical devices, the Therapeutic Goods Administration (TGA), last year changed the classification of psilocybin and MDMA within the country’s Poisons Scheme to allow for them to be prescribed by authorized psychiatrists.
For this purpose, they are considered Schedule 8 Controlled Drugs but for all other purposes remain Schedule 9 Prohibited Substances.
Since July 1, 2023, specially authorized psychiatrists have been able to prescribe psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder.
Earlier this month, the co-founder of outpatient psychiatrist-led mental health organization Monarch Metal Health Group Ted Cassidy became the first doctor to prescribe MDMA psychedelic-assisted therapy for PTSD to a female patient under the Authorized Prescriber Scheme.
“I am proud that Australia has taken world leadership in translating psychedelic research into clinical reality,” he wrote in a post on LinkedIn.
Several Canadian psychedelics-focused biotech companies have already overcome the significant regulatory and logistical challenges surrounding the export of controlled substances like MDMA and psilocybin into Australia, paving the way for them to supply the nation’s scheme as more patients are prescribed these drugs to treat mental health conditions.
British Columbia-based Filament Health Corp earlier this month completed its first export of its botanical psilocybin drug candidate to its partner Reset Mind Sciences located in Perth, Western Australia.
The company is a longtime supplier of Canada’s Special Access Program, a framework which allows healthcare professionals to request access to non-marketed drugs not available for sale such as psilocybin or MDMA for patients with a serious or life-threatening condition on a case-by-case basis.
While Filament’s drug product will be used by Reset for research purposes, the export, which is believed to be the first export involving botanical psilocybin into Australia, demonstrated the company’s regulatory capabilities.
Reset is advancing a GMP licence application to manufacture psilocybin products from botanically sourced psilocybin for human consumption as it awaits the publication of the TGA’s order governing psilocybin production in Australia, Filament highlighted.
“We are closely monitoring the Authorized Prescriber Scheme, and we commend the TGA for including botanical products in their draft guidance for the products,” a Filament Health spokesperson told Proactive.
Another Canadian firm working to supply Australia’s scheme is PharmAla Biotech, a company focused on the manufacturing of novel MDXX class molecules including MDMA.
In November, PharmAla announced it had completed its first shipment of MDMA and psilocybin to Cortexa, its Australian joint venture with Vitura Health Limited.
This marked the first time that these drugs have been brought into Australia specifically to be used under the Authorized Prescriber Scheme rather than for clinical trial purposes, the company said.
Drug manufacturer Optimi Health Corp through a partnership with Mind Medicine Australia (MMA), an Australian mental health charity and provider of psychedelic-assisted therapy training, is positioned to be another supplier of the scheme.
Through this partnership, announced in March 2023, Optimi is contracted to supply its MDMA formulation PTI-MHCL and GMP psilocybin capsules to MMA on an ongoing basis.
In a November 2023 shareholder update, Optimi said it continues to collaborate with MMA to navigate intricacies related to the scheme.
It noted that once a psychiatrist has received approval from the TGA to become an authorized prescriber it can apply for an import permit for Optimi’s drug candidates. The approval of such a permit can take up to 45 days after which Optimi will initiate the shipment of the drugs to Australia.
Story from – Proactive Investors
CASE NUMBER: 23-771501
Hamilton October 6, 2023
Two Illegal Psilocybin Store Fronts Closed Permanently the Mushroom Cabinet and Shroomyz …
Hamilton Police have permanently closed the doors on two illegal psilocybin businesses that were the subject of previous police warrant executions.
On Friday, October 6, 2023, Hamilton Police shut down two illegal psilocybin stores permanently. The Mushroom Cabinet and Shroomyz are now closed, with cooperation from landlords, the locks have been changed and Hamilton Police signage installed indicating that any entry could result in Break and Enter or other applicable charges.
Hamilton Police have charged, a 35-year-old male in relation to the Mushroom Cabinet with CDSA 5(2) Psilocybin and Proceeds of Crime Under $5000.
The following was seized from the Mushroom Cabinet;
- 1.3 kilograms of dried Psilocybin
- 33 bottles containing 20 capsules of Psilocybin in each (660 capsules total)
- 30 Psilocybin chocolate bars
- 25 Psilocybin chocolate squares
Hamilton Police have also charged, a 50-year-old female in relation to Shroomyz with CDSA 5 (2) and Proceeds of Crime Under $5000.
The following was seized from Shroomyz;
- 404 packages of dried Psilocybin (2.83 kilograms total)
- 308 chocolate cars 3.5 grams each bar (1.08 kilograms total)
- 713 bottles containing 14260 capsules total (3.5 kilogram total)
- 19 jars of Psilocybin butter
- 228 packages of gummies each containing 4500mg (1 kilogram total)
In total, Hamilton Police have seized 9.71 kilograms of dried psilocybin with a street value of $97,100.
A third store, Shroom Godz, opened yesterday directly across the street from the Mushroom Cabinet. Police have since informed the owner of Shroom Godz of the recent measures implemented on the two neighbouring businesses and the owner has made a decision to cease operations.
Hamilton Police remind the public that psilocybin remains a schedule III drug and a restricted substance under the Controlled Drugs and Substance Act (CDSA). Psilocybin is illegal to possess and at this time, there are no legal licensed options available, under which psilocybin dispensaries are allowed to operate.
If you have any information that you believe could assist Police with the investigation into this crime, please contact Detective Sergeant Greg Slack at 905-546-3810.
To provide information anonymously call Crime Stoppers at 1-800-222-8477 or submit your anonymous tips online at http://www.crimestoppershamilton.com
MAKE YOUR VOICE HEARD!
Story from Hamilton Police website
I Went to Rehab for Alcoholism 18 Times. Only Psychedelics Helped
“Using [psilocybin] four to six times has managed to achieve what the other therapies didn’t do in years.”
A version of this article originally appeared on VICE Germany.
I met Amanda at a pain therapy clinic in Zurich last December. She was sitting on a chair, hands folded neatly in her lap – she’d come here with her husband Tim for one of her regular visits to neurologist Livia Granata, one of the few specialists in Switzerland offering psychedelic therapy.
For the past seven years, Amanda hasn’t lived in her flat with her partner and their children, but outside on the balcony. She stays in an improvised shelter her husband made for her, only going in to use the toilet – and the pandemic only further tightened the grip her anxiety disorders have on her life.
A year ago, Amanda probably wouldn’t have shown up for this appointment at all, either cancelling at the last minute or simply letting it pass. Over the years, she’s been through too many treatments – experimental therapies that brought little to no relief. But in April 2022, she found her way to the clinic – and to the first treatment she felt ever truly worked.
The first studies looking at psychedelic therapy date back to the 50s and 60s, but research projects were shut down in the two decades that followed as psychedelics became increasingly criminalised. One of the countries that contributed most to this research is Switzerland, where psychedelic therapy was briefly legalised between 1988 and 1993 and used to treat almost 200 private patients.
“I was a functional alcoholic,” said Amanda, recalling the first years of her addiction. “I only drank in the evenings, but I drank way too much and it was starting to affect my family life.” In the beginning, alcohol helped her escape unwanted thoughts, but that soon stopped being effective. She kept drinking anyway.
In 2007, Amanda realised she had a problem and decided to seek help. But her children were little at the time and she couldn’t bear the thought to leave them for long stretches of time. Over the intervening years, she’s visited rehab centres and psychiatric clinics over and over again – 18 times in total, some for a few weeks, others for months. She was often institutionalised with people with severe and diverse mental health conditions, and that made her feel unsafe. Sooner or later, she’d relapse. “Even though I was there voluntarily and I could ask to go out, it was just the feeling of being locked in [that scared me],” she remembers.
As time went on, Amanda became suicidal because she “couldn’t beat this thing”, as she puts it. Her attempts at suicide – 12 in total – caused her to be forcibly committed, fuelling the cycle of failed therapies and making her sicker and sicker.
Her last hospital stay in the summer of 2021 made it clear to her she never wanted to go back to a psychiatric ward again. “I’d lost a lot of weight, it went down to 50kg,” she says. “I’d just had enough.” Then, she came across a documentary about a study in Switzerland where alcoholics are treated with psychedelics. She signed up to participate and was referred to Livia Granata.
Initially, the two tried a course of therapy involving ketamine IVs. Ketamine is an anaesthetic used in emergency care and as a recreational drug, but has psychedelic effects. It’s also been shown to be an effective antidepressant and anti-suicidal drug, and particularly good with cases of treatment-resistant depression.
Then Granata decided to try administering her psilocybin – 20 milligrams per session at first, then 30 because she “tolerated it extremely well”, Granata says. They did six sessions of about eight hours, or until the psychedelic high was over. Granata and her team are not therapists – they simply supervise Amanda while she listens to music, lies down on the couch or the carpet, puts a mask over her eyes and just gives in to the feeling.
Many patients cry during treatment, says Aisha Savdi, a medical assistant in the team. Some want to be held, others want to be left alone. The sessions often bring up past memories and emotions that have been repressed. Many report that they look at their lives like an outsider. Things become clearer; perspectives change.
For Amanda, the hallucinogenic effect was weaker than with ketamine. The lights were slightly blurred, but above all, she felt good: relaxed, anxiety gone. “Tim had trouble getting me back to the car, because I was looking at all the bright colours like a kid,” she says. “It certainly changed my attitude a bit, I feel the weight lifted.”
Since then, she and the people in her life have observed a huge improvement in her severe depression and anxiety. Although she still can’t bear to move out of the balcony, she’s been able to leave her house, visit the hairdresser, go on a walk or to see a friend. She can watch some videos explaining childhood trauma without shutting down. “My mind seemed more open so I could really take it in,” she explains.
And something else is different, too – her urge to drink is gone. She has been abstinent since April 2022 – her longest time without alcohol in 20 years. Granata has prescribed a ketamine nose spray to help with the cravings, which sometimes still happen, especially when something changes in her life. The holiday was challenging, for instance – but so far, she’s been able to swerve drinking.