Little Green Pharma gets green light ‘ethics approval’ from TGA ahead of SleepWell study

Cannabis company, Little Green Pharma (ASX: LGP) has been growing its market share all while pleasing investors with its latest announcement that it has obtained an Ethics Approval for its proposed Australian-based, multi-site, placebo-controlled ‘SleepWell Study’ where it will be trialling the Company’s LGP Classic CBD 50 cannabis oil medicine and its effectiveness on stress reduction and improvement on quality of sleep in healthy adults.

Aiming to eventually achieve TGA approval, the Company will be relying on this study to show successful and promising results as this is what will ultimately be what they need to progress this medication to market.

In fact, the Company has approached with caution when seeking the approval as an earlier decision in December 2020 saw a series of certain CBD preparations down-scheduled from a Schedule 4 (Prescription Only Medicine) to a Schedule 3 (Pharmacist Only Medicine).

“We are delighted to receive ethics approval for LGP’s SleepWell Study, which is yet another significant achievement for the LGP team and its product and drug delivery innovation strategy. This represents a significant milestone for Australian patients along the pathway to ultimately accessing Australian made CBD products at their local pharmacy ‘over the counter,” said Little Green Pharma CEO, Fleta Soloman.

With the global market for insomnia treatments estimated to balloon to $5.4 billion by 2023, many of the current treatments for insomnia have major limitations including abuse and addiction, questionable or uncertain efficacy, and mostly leaving the patient with hangovers.

Currently, there are no Schedule 3 registered CBD products in the Australian market and with the Pharmacist-only CBD market predicted to reach $250 million and over 2 million patients within the next few years, LGP’s decision to progress the trials and prepare themselves for future market expansion has reinforced the Company’s push to garner with its unique CBD formulations.

Since the beginning of 2022, LGP shares have crushed 70% lower from $0.61 to its all-time low of $0.165. Currently, shares sit on $0.18 at the time of writing.