Cannabis Pain Study
An observational study investigating and auditing the safety and further efficacy of pharmaceutical-grade submicron particle cannabis (NanoCelle® 1:1 THC 8.93mg/ml and CBD 8.93mg/ml) in an oro-buccal spray, for the management of Cancer and Non-cancer related pain in general and specialty medical practices.
- Age 18+
- GP or specialist has indicated treatment with Medlab product
- The patient can be legally prescribed
- Patients must refrain from other cannabis products
- Up to 12 months duration
- Prescribing Doctor submits 1 de-identified patient report per month
- The patient receives Medlab Product at a subsidised price
* Study approved by the National institute of integrative Medicine(NIIM) Human Research Ethics committee, Approval ID 0052E_2019
NON-ARTG MEDICINE UNDER CLINICAL TRIAL
Observational Study Report
- An interim analysis of 119 patients who have completed six and 12-month administration of the NanoCelle® THC/CBD oral buccal spray has shown a 55%^ reduction in pain scores, with significant quality of life improvements also reported in the areas of sleep, mood and general activities.
- It is the fifth monitoring report on the 12-month study and complements results from the earlier Phase I Royal North Shore Hospital pilot study in New South Wales.
- Medlab has recruited almost 40% (or 801 people) of a total 2000 participants into the observational study, ranging in age from 21 years to 99 years with females representing 59% of the intake.
- Approximately 3% of the 801 participants presented with cancer-induced bone pain, with 99% registering chronic pain and 1% with acute pain.
- Preliminary analysis of their Brief Pain Inventory (BPI) scores after six and 12 months showed improvement in mean pain scores from 6.5 at the commencement of the study; to 5.5 at six months; and 4.7 at 12 months.
- Of the 119 patients (65% female; 35% male) who have completed six and 12-month courses of NanoCelle® THC/CBD oral buccal spray, approximately 50% had muscular or neuropathic pain; 32% had soft tissue pain with muscular pain; 11% had visceral pain; and 7% registered “other categorised pain”.
Safety and Tolerability
The results support the safety and tolerability of NanoCelle® THC/CBD oral buccal spray for pain in a chronically ill cohort of patients with intractable pain. Furthermore, the study presented preliminary analgesic efficacy of NanoCelle® THC/CBD oral buccal spray for pain management in a real world setting while remains consistent with the growing body of evidence supporting the drug.
^ Results are relative to the 55% of participants that had been tracked as of today’s date.
Study approved by NIIM Human Research Ethics Committee, approval ID 0052E_2019.
How To Access An Unregistered Cannabis-Based Product?
This video provides information about how the TGA provides safe and legal access to medicinal cannabis products in appropriate circumstances. TGA has useful resources to help you navigate the special access scheme for the access of unregistered drugs that are currently under investigation. Individual consumers cannot apply to the TGA to obtain access to unapproved medicinal cannabis products. Access can only be arranged through an Australian registered health practitioner. Approval or authorisation is granted on a case-by-case basis.
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