Pharmacokinetics and pharmacodynamics of cannabis-based medicine in a patient population included in a randomized, placebo-controlled, clinical trial

Patients with multiple sclerosis (MS) often experience neuropathic pain and spasticity. Cannabis-based medicine (CBM) has been considered for symptom relief, modulating pain signals and inflammation through cannabinoid receptors. Oral THC and CBD have limited bioavailability due to liver metabolism. THC is converted to an active metabolite, then further processed and excreted. It accumulates in fatty tissues, leading to prolonged excretion. This study aimed to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of oral CBM in a steady-state condition in MS patients, analyzing blood samples and evaluating pain and spasticity.

• 1
  The variation in daily dose and PK between individuals was considerable in a steady state, yet comparable with previous reports from healthy controls.
• 2
  Based on a simulation of the best model, the estimated PK parameters (mean) for THC (5 mg) were Cmax 1.21 ng/mL, Tmax 2.68 h, and half-life 2.75 h, and for CBD (10 mg) were Cmax 2.67 ng/mL, Tmax 0.10 h, and half-life 4.95 h, respectively.
• 3
  No effect was found on the PD parameters, but the placebo response was considerable. More immediate adverse events were registered in the active treatment groups compared with the placebo group.