NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers

Inclusion Criteria: At Screening Phase Participants must fulfil all of the following criteria:

• Prospective male and female participants that are:

1. in the age range 18-65 years or
2. 65 to 75 years without significant co-morbidities (heart, lung, liver or renalfailure, myocardial infarction, cerebral vascular accident, peripheral vasculardisease, chronic obstructive pulmonary disease, dementia, connective tissuedisease or diabetes mellitus with end-organ damage)

• Metastatic bone pain from a cancer diagnosis is the only major cause of pain.
• Documented proof (imaging) confirming the Metastatic Bone Disease at the current siteof pain and that there has no been treatment since diagnosis
• Meet International Classification of Diseases, Tenth Revision (ICD-10) codes for painmanagement criteria (i.e., bone cancer pain)
• During the screening period, the participant is on stable opioid pain management andpain severity (NPRS) ≤ 8 with a maximum variation of ± 1
• Pain Detect score > 18
• Participant willing and able to provide informed consent and follow study procedures

1. including agreeing to not drive or operate heavy machinery; and
2. females of child-bearing potential agree to use reliable contraception during theduration of the clinical trial

• Patient deemed tolerable to Oxycodone and NanaBis™ determined by medical history ofallergies to cannabinoids or opioids
• Patient must not be a participant in a clinical trial or study.

Exclusion Criteria: At Screening Phase Participants will be excluded if they meet any of the following criteria that include:

• History of epilepsy or recurrent seizures
• Moderate to severe medical conditions such as

1. Severe hepatic, cardiovascular, pulmonary or renal impairment or
2. Psychiatric disorders (i.e., unstable schizophrenia, recent drug-inducedpsychosis, severe mood disorders), that would be assessed at the medical screen

• If participants have been diagnosed with a current substance abuse disorder
• Women who are pregnant, lactating or planning to become pregnant
• Identified concerns by the nursing / medical team relevant to the safe storage ofmedications (i.e., NanaBis™ or standard medical therapy)
• Participants who may not be available for follow up (i.e., planned or expected travelor other)
• Participants plan to undergo any treatment that will substantially reduce the burdenof disease (and therefore bone pain) during the screening, titration or maintenancephase of the clinical trial such as radiotherapy or cytotoxic chemotherapy
• Participants who are unable to withhold all analgesia (apart from which is part ofthis trial) during the titration and maintenance phase of the study, includingbisphosphonates, or are currently exceeding equivalence of 70mg BD Oxycodone CR.Medications such as bisphosphonates may be coordinated so they are given either sideof the excluded period that covers the titration and maintenance phases
• Participants will NOT be excluded if they are being treated with maintenancepharmacotherapy to prevent progression of disease such as steroids and hormonetherapy, which may be continued during the trial at a stable dose
• Participant will be excluded if they are participating in any other clinical trial orstudy.