Valeritas Holdings‘ proprietary h-Patch device can be used to administer cannabidiol by an under-the-skin (subcutaneous) infusion, prolonging the time the medication remains in circulation in the body and maximizing its therapeutic effects, a preclinical study has found.
Cannabidiol (CBD) is a cannabis-derived, purified liquid formulation that has strong anti-seizure, and anxiolytic, or anxiety-reducing properties.
Based on findings from multiple clinical trials, the U.S. Food and Drug Administration (FDA) approved CBD — sold under the brand name Epidiolex, by GW Pharmaceuticals — in June 2018 for the treatment of children with Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy that fail to respond to treatment with conventional anti-epileptic medicines.
Meanwhile, other studies have suggested that CBD also may help reduce pain, muscle tightness (spasticity), and inflammation in people with multiple sclerosis (MS). For that reason, cannabidiol should be included in current standard-of-care therapies for these patients, the researchers say.
“CBD has tremendous pharmaceutical potential. However, the poor bio-availability and other issues that result from oral dosing are major shortcomings that increase the cost and variability of treatment,” Ilo E. Leppik, MD, the former president of the American Epilepsy Society, and current professor of neurology and pharmacy at the University of Minnesota, said in a press release.
Bio-availability refers to the extent and rate at which a medication is absorbed by the body’s circulatory system after being administered. Researchers note that CBD’s bio-availability, when administered orally, is estimated to range between 6 and 10%.
“We have found that a fatty meal can increase the amount of CBD absorbed by five times, compared to that taken on an empty stomach, so there is a dire need for an improvement in the consistency of dosing. Subcutaneous [under-the-skin] administration would have two advantages: it would greatly increase the bio-availability thus reducing the amount needed, and it would eliminate the variability of diet on CBD uptake,” Leppik said.
Now, the medical technology company Valeritas has announced that its proprietary h-Patch device can be used to administer CBD by an under-the-skin infusion. According to findings from a pilot preclinical study, this method can effectively overcome the issues found in oral administration.
In the study, CBD was delivered over a single 24-hour period using the h-Patch. Two CBD dosage regimens were tested: 40 mg/24h, and 76 mg/24h.
Key findings from the study showed that CBD was rapidly absorbed and distributed in the body when administered through an under-the-skin infusion over a period of 24 hours using the h-Patch device. Moreover, CBD levels in the bloodstream rose quickly within an hour after the start of the infusion, and were still detectable 24 hours after the end of the infusion.
The effects were similar with the two CBD dose regimens tested.
“This study highlights Valeritas’ partnering opportunities to leverage the h-Patch technology beyond insulin delivery,” said John Timberlake, president and CEO of Valeritas. “Subcutaneous infusion is a powerful delivery method for a variety of drugs with solubility, permeability, and first-pass metabolism challenges, and the h-Patch may offer a cost-effective alternative means of reliable and patient-friendly drug dosing.”
The company’s V-Go insulin delivery device is the first product based on the h-Patch technology that has been approved by the FDA. Valeritas is now planning to present the detailed findings from the preclinical study with CBD at an upcoming medical conference later this year.
“In the United States alone, approximately 160 clinical trials with CBD are currently enrolling patients or preparing to do so. Disease targets include epilepsy, PTSD, pain, cardiovascular disease, gastrointestinal disorders, multiple sclerosis, eye conditions, spinal cord injuries, addiction, and cancer,” Leppik concluded.
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