Over-the-counter cannabis pain relief on the horizon

Rachael Ward |

If approved the cannabis pain relief tablet could be available without prescription.
If approved the cannabis pain relief tablet could be available without prescription.

Over-the-counter cannabis pain relief could be available in Australia by the end of 2024 if a phase three clinical trial is successful.

Promethean BioPharma is currently testing the efficacy and safety of its new medicinal cannabis tablets for mild to moderate pain.

The drug does not contain THC, the psychoactive ingredient that gives an effect of being high and currently prevents medicinal cannabis users from driving.

The tablet can be dissolved in water with initial testing showing a faster onset and higher absorption rate than oil treatments.

“Incredibly exciting that we actually have the trial running, it’s taking a huge amount of time to design it correctly,” the company’s global chief executive Peter Comerford told AAP.

“Research papers have been written on cannabis but very few phase three clinical trials of this rigour have actually been done.”

There will be 172 people taking part in a double-blind placebo study in Sydney, the Central Coast, Brisbane and Canberra which is due to finish by June next year.

Mr Comerford said it if registered, the medicine could eventually be used by people who need an over-the-counter alternative to paracetamol and ibuprofen which can be dangerous in high doses.

Opioid codeine was previously widely available but became prescription-only in 2018 over addiction concerns.

Mr Comerford said medicinal cannabis was a less toxic, more powerful option for managing pain.

TGA stock
The TGA may consider approving the cannabis pain relief tablet late next year. (Lukas Coch/AAP PHOTOS)

The medication has been designed to meet strict Therapeutic Goods Administration guidelines and trial participants are taking 150 mg daily in line with Schedule 3 pharmacist-only medication requirements.

Once the trial wraps up, the results will be presented to the regulator for assessment which can take up to nine months.

Chronic Pain Australia director Donna Ciccia said there was a need for a medicinal cannabis product that was affordable, readily available and did not have stigma attached.

“This would be an absolute game changer,” Ms Ciccia said.

She currently spends $500 a month on cannabidiol, known as CBD, to relieve pain from endometriosis and an autoimmune connective tissue disorder but points out that price is prohibitive for many people.

“If we can get something that is across the counter, lower cost, that would be brilliant compared to traditional medicinal cannabis at the moment where it’s quite a complex process to get prescribed,” she said.

In January 2018, then Health Minister Greg Hunt said he wanted Australia to become the world’s biggest exporter of medicinal cannabis.

Mr Comerford said if his company’s product was registered it would kick start that process, with plans to seek approval in Europe, the United States and other jurisdictions.