Clinical data reassures safety and tolerability of THC-based medicine Namisol®
Echo Pharmaceuticals B.V. announces that highly reassuring clinical safety data has been collected with its leading THC product Namisol® in more than 200 patients. Primary results indicate that Namisol® is safe and well tolerated and shows predictable absorption characteristics in patients of different age groups and gender.
Weesp, The Netherlands – August 2015 – Namisol® has been administered to healthy volunteers, including elderly, and patients with multiple sclerosis, dementia, chronic pancreatitis and postsurgical abdominal pain. Extensive pharmacokinetic, pharmacodynamics and safety data has been collected in these trials.
In all clinical trials performed with Namisol®, no Namisol® related Serious Adverse Events were reported. All other reported Adverse Events of Namisol® were mild to moderate and the vast majority of these effects were related to THC. In none of the studies performed with Namisol® clinically relevant effects on vital signs such as heart rate, blood pressure and ECG were observed.
For the elderly, safety data on cannabinoids including THC, is scarce. During a clinical trial phase I study positive safety data was obtained in elderly volunteers. Following these results during clinical trials with dementia patients, no difference in Adverse Events where observed between the Namisol® group and the placebo group. In this fragile elderly population, where falling is a major concern, also no effect of Namisol® on posture stability was reported.
Namisol® is the world’s first oral tablet that contains pure and natural Δ9-tetrahydrocannabinol (THC or dronabinol) in fixed dosages with high, predictable bioavailability and a long, stable shelf life at room temperature. Namisol®’s current clinical program includes, in addition to the MS indication, clinical trials for Alzheimer’s disease and chronic pain.
About Echo Pharmaceuticals B.V. (“Echo”)
Echo Pharmaceuticals (‘Echo’) is a privately owned specialized pharmaceutical company, with more than 10 years of experience, in leading innovation in advanced cannabis-based medicines and products. The company is headquartered in Nijmegen, The Netherlands, with offices and GMP facilities in Weesp. Echo has developed an advanced program on cannabis-based medicines and drug delivery technologies. The company’s strong and resilient IP portfolio and proprietary knowledge on conventional and advanced technologies for extraction, purification and formulation has resulted in a range of high quality market-ready products, placing Echo in a unique market position in the medicinal cannabis field.
To learn more about Namisol® & Echo Pharmaceuticals
Echo Pharmaceuticals B.V.
+31(0)294 457 353
Melanie Wijnands - Communication Manager