Tetrahydrocannabinol (THC), a cannabinoid compound derived from the cannabis plant, for pain relief, is associated with psychoactive and adverse effects, such as changes in mood, perception, and euphoria particularly at high therapeutic doses. ZYN001, a synthetic form of THC developed by Zynerba Pharmaceuticals, is thought to be delivered more safely to the body.
What Are the Current Treatments Available?
ZYN001 has been recently developed as a pain-relieving chemical for patients with chronic pain. More specifically, the available up-to-date data revealed a promising effect of alleviating nerve pain in the skin (peripheral neuropathy). Since approximately half of the patients with fibromyalgia syndrome (characterized by generalized pain in the muscles, joints, and tendons) have peripheral neuropathic pain, it is therefore important to evaluate the possible role of ZYN001 in the management of associated pain. In addition, the sponsoring company has announced starting the Phase I of a relevant clinical study for using ZYN001 for alleviating the symptoms of Tourette syndrome. The latter occurs mostly in children and adolescents and is characterized by the onset of repeated and sudden movements or vocalization called “tics.”
The currently developed ZYN001 is given via a transdermal patch once daily to deliver the active drug into the blood circulation. This is because oral administration can limit its efficacy and presence in the blood stream.
What’s ZYN001 Do?
The use of THC and its derivatives (nabilone and dronabinol) has been associated with psychoactive effects on the body, such as hallucinations, dependency, and mood alteration. These effects emerge when the drugs are given via mouth in the form of pills or oromucosal sprays. The liver breaks down high amounts of these drugs before they enter the bloodstream, resulting in inconsistent dosage and the development of psychoactive side effects.
When given through a transdermal patch, ZYN001 only a small and effective dose of the drug is delivered to the blood stream, allowing higher efficacy. Further, by avoiding dosage fluctuations, minimal side effects are developed. The preliminary results in the experimental animals confirmed that the plasma concentration of ZYN001 is remarkably lower than that when THC is given orally, but it the dose is still effective.
How Does ZYN001 Compare to Previous Treatments?
Unlike THC, ZYN001 can be absorbed through the skin, where it can be converted into THC and another chemical by specific enzymes in the skin. The phase I study on patients with fibromyalgia and neuropathic pain has been initiated and is currently investigating the efficacy and possible side effects of ZYN001 in comparison to another chemical of no therapeutic potential (placebo). The main aim is to provide a constant level of THC, via transdermal patches, that is clinically effective and safely delivered.
In general, ZYN001 seems to be a promising solution for THC side effects. It can be considered a pro-drug since it is administered in an inactive form into the skin and then is chemically converted to an active drug in the bloodstream. If able to confirm its clinical effectiveness along with a good safety pattern, Zynerba Pharmaceuticals will get the approval of the food and drug administration to market ZYN001.