Zynerba Pharmaceuticals launched a Phase 1 clinical program to assess the safety and tolerability of ZYN001, a cannabinoid product (tetrahydrocannabinol, or THC) delivered by a skin patch. The program is expected to include a Phase 2 study in patients with fibromyalgia.
The clinical program aims to study the effects of single or multiple increasing doses of ZYN001 in different formulations and determine the optimal dose to be used in Phase 2 clinical trials in patients with chronic pain.
“The initiation of the ZYN001 clinical program is an important milestone for the company, as we now have two clinical stage assets which upon approval may address serious unmet medical needs in a variety of disease settings,” Armando Anido, Zynerba’s chairman and CEO, said in a press release.
“We believe that ZYN001 will be important in a number of pain indications, given THC’s known impact on pain transmission and analgesic effect in patients suffering from chronic pain,” Anido added. “Our state-of-the-art transdermal [skin] patch delivery offers unique advantages to patients, including the potential for more consistent, sustained delivery and better tolerability of THC.”
ZYN001 is a pro-drug of THC (an inactive/less active form of the drug) whose delivery is made through a skin patch. This method allows the drug to be absorbed through the skin and go directly into the circulatory system, maximizing its effects. In comparison, oral formulations require a drug to pass through the liver, where part of the medication is lost due to normal metabolic reactions; in this way, only a small amount of the drug will be absorbed into the circulatory system.
The clinical program for ZYN001 starts with a randomized, double-blind Phase 1 study that will assess the drug’s safety, tolerability, and behavior in the body. Researchers will compare a single dose of ZYN001 and a placebo, in different formulations and wear times (24 hours to one week) in 48 healthy individuals.
According to the results of this trial, Zynerba will assess two formulations in multiple patch applications for 14 days, or a placebo, in up to 32 healthy individuals. The idea is to deliver constant levels of THC to optimize the drug’s efficacy while minimizing side effects in the central nervous system.
If the Phase 1 trial is successful, Zynerba will launch a Phase 2 clinical program to test ZYN001 in patients with fibromyalgia and neuropathic pain, which is expected to start in mid-2017.
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