Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sativex Low Dose · 2 trials · 3 indications
The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Subjects recorded their use of escape medication each day on their diary card.
A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo control |
| Sativex | EXPERIMENTAL | Active treatment |
| THC Alone | EXPERIMENTAL | Active treatment |
| Sativex Low Dose | EXPERIMENTAL | Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD. |
| Sativex Medium Dose | EXPERIMENTAL | Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD. |
| Sativex High Dose | EXPERIMENTAL | Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours. |
| Sativex® | DRUG | Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours. |
| THC Alone | DRUG | Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours. |
| Sativex Low Dose | DRUG | Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD. |
| Sativex Medium Dose | DRUG | Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD. |
| Sativex High Dose | DRUG | Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD. |
Inclusion Criteria: * Willing and able to give informed consent. * Male or female, age 18 years or above. * Diagnosed with cancer of any type, which is considered to be terminal. * Diagnosed with cancer-related pain which is not wholly alleviated with their current strong opioid treatment and whose...
Sativex is an investigational drug being studied for the treatment of spasticity in children aged 8 to 18 years with cerebral palsy. It has also been evaluated in healthy subjects for pharmacokinetic studies, including food effects and drug interactions, and for its abuse potential.
Sativex is being developed by Jazz Pharmaceuticals plc, a company traded on the NASDAQ under the ticker symbol JAZZ. The company is conducting clinical trials to evaluate the drug's safety, efficacy, and pharmacokinetics in various patient populations.
Sativex is in Phase 1 clinical development. The drug has completed Phase 1 trials evaluating its pharmacokinetics, including food effects and drug interactions, as well as a Phase 3 trial for spasticity in children with cerebral palsy. It remains investigational and is not yet approved.
Sativex has been studied in several completed clinical trials. These include NCT01322464, a Phase 1 food effect study; NCT01323465, a Phase 1 drug interaction study with rifampicin, ketoconazole, and omeprazole; NCT01898520, a Phase 3 study for spasticity in children with cerebral palsy; and NCT02325011, a Phase 1 study with fluconazole.
Sativex is a specific product name for a cannabis-based medicine. The drug is being studied for conditions such as cerebral palsy and spasticity. It is developed by Jazz Pharmaceuticals and is currently in clinical trials, though it has not been approved for these indications.