|
 Zynerba's gel contains a synthetically processed formulation of
cannabidiol (CBD), a non-psychoactive component of the cannabis
plant.
Although many U.S. states have sanctioned the medical and/or
recreational use of cannabis, drugs derived from the plant could
take longer than others to hit the market.
Under U.S. federal law, marijuana is considered a dangerous
substance with no medicinal value, making additional approvals for
marijuana-derived treatments necessary prior to launch.
Two doses of Zynerba's ZYN002 gel were tested against a placebo in
the study.
Neither dose induced a statistically significant improvement in
seizure frequency versus the placebo in patients who were already on
up to three anti-epileptic medications.
The 188-patient study comprised adults suffering from epilepsy with
partial seizures, which occurs when epileptic activity takes part in
a localized part of the brain.
Even though the availability of the drug in blood plasma increased
with the higher dose, it did not translate into a clinically
meaningful benefit.
Based on this data, Cantor Fitzgerald analysts said they were
uncertain whether there was a suitable path forward for development
of ZYN002 in adult focal seizures.
Data from studies evaluating the gel's use in osteoarthritis
patients and in children with Fragile X Syndrome is expected in the
coming months, the company said.
Zynerba is still evaluating data to determine next steps, but said
it was not giving up on epilepsy as a target, on a conference call
with analysts.
[to top of second column] |
Britain's GW Pharmaceuticals, considered a pioneer in cannabis-drug
development, is expected to file a U.S. marketing application for
its CBD-based epilepsy drug, Epidiolex, this year.
A New England Journal of Medicine editorial earlier this year noted
that Epidiolex data represented "the beginning of solid evidence for
the use of cannibinoids in epilepsy," after an era of anecdote and
emotion-based debates.
The intrinsically low bioavailability of CBD in Zynerba's gel seemed
like a potentially significant hurdle for a systemically acting
topical medicine, Leerink's Paul Matteis said in a client note
titled "ZYNE Topical CBD Failure Removes an Overhang for GW".
Bioavailability denotes the degree by which a drug's active
ingredients are absorbed by the blood.
Zynerba's shares plunged as much as 60 percent to $5.93 in morning
trading. GW's shares rose about 4 percent to $122.45.
(Reporting by Natalie Grover in Bengaluru; Editing by Sai Sachin
Ravikumar and Martina D'Couto)
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