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As public focus on the issue of medicinal cannabis continues to grow, Zynerba Pharmaceuticals has announced that its transdermal tetrahydrocannabinol (THC) patch ZYN001 has failed in Phase 1 trials to achieve targeted levels of THC in the blood of patients.
Zynerba attempted to assess the efficacy of a range of dosages and wear times in 60 participants, who wore the patches for a duration of between 24 hours and two weeks, but the drug did not hit the target levels of 5ng/ml to 15ng/ml of THC. The news caused the company shares to plummet 21%.
However, the company did note that the treatment was well tolerated, with no serious adverse of events or discontinuations and minimal skin erythema.
The disappointing news comes just weeks after the breakthrough news that the FDA decided to approve GW Pharma’s Epidiolex (cannabidiol) as an adjunctive therapy in the treatment of seizures in patients with Lennox-Gastaut syndrome or Dravet syndrome. The move marked the first approval in the US of a drug product derived from the controlled substance cannabis.
Given the bad news, Zynerba has confirmed it will now shift focus onto its othercandidatye, ZYN002, in the treatment of Fragile X syndrome, developmental and epileptic encephalopathy, and adult refractory epilepsy.