INSYS Therapeutics Presents New Clinical Data from Long-Term Safety Study of CBD Oral Solution in Refractory Pediatric Epile...
December 04 2018 - 6:00AM
Pharmaceutical-grade cannabidiol (CBD) oral solution made by INSYS
Therapeutics, Inc. (NASDAQ: INSY), a leader in the development,
manufacture and commercialization of pharmaceutical cannabinoids
and spray technology, was generally well-tolerated—even at high
doses—as an investigational treatment for refractory pediatric
epilepsy, according to new clinical data from a long-term safety
study presented yesterday at the American Epilepsy Society (AES)
2018 annual meeting.
“The results of this study support the promising safety profile
of CBD oral solution from INSYS in the context of treating
pediatric patients with intractable seizures due to epilepsy,” said
James W. Wheless, M.D., professor and chief of pediatric neurology
at the University of Tennessee Health Science Center in Memphis,
where he directs the Neuroscience Institute & Le Bonheur
Comprehensive Epilepsy at Le Bonheur Children’s Hospital and holds
the Le Bonheur Chair in Pediatric Neurology. “In addition, these
long-term safety data are consistent with those from other studies
of CBD in refractory pediatric epilepsy.”
Dr. Wheless presented the results of this multicenter,
open-label, flexible-dose study (INS011-14-030) during AES Poster
Session 3. The presentation (Abstract 3.294) reported safety data
from 52 patients (nine infants, 26 children and 17 adolescents)
from 11 U.S. clinical sites.
A total of 45 patients completed the study, which was designed
to assess the long-term safety and tolerability of the company’s
proprietary formulation of CBD oral solution as adjunctive
treatment for pediatric patients (ages 1–17 years old) with
treatment-resistant epilepsy. Patients received doses of CBD oral
solution at 10, 20, or 40 mg/kg/day (in two divided doses) for
approximately 48 weeks, with dose changes at the investigators’
discretion. Defined as the dose with the longest duration, the mean
modal dose was 24.42 mg/kg/day (higher in infants than in children
and adolescents); and the mean total duration of study drug was
311.1 days (with a maximum exposure of 384 days).
Safety assessments included treatment-emergent adverse events
(TEAEs), electrocardiograms, physical and neurologic exams and lab
tests. Additional assessments included Clinical Global Impression
of Severity (CGI-S) and Clinical Global Impression of Improvement
(CGI-I) by investigator and caregiver at baseline (CGI-S only),
Week 4, 8, 12, 24 and 36, final visit and follow-up visit.
Through 48 weeks of follow up, 47 patients (90.4 percent)
experienced one or more TEAEs during the study; and 24 patients
(46.2 percent) had TEAEs that were possibly or probably related to
the study drug, most being mild or moderate in intensity. A total
of 278 TEAEs were reported, with the following reported in at least
five subjects: seizure, upper respiratory tract infection,
somnolence, anemia, diarrhea and pyrexia. Of the 37 serious adverse
events reported, three were considered possibly related to the
study drug: moderate change in seizure presentation; moderate
ataxia; and worsening seizure exacerbation.
Eligibility criteria included participation in a previous CBD
study (specifically, INS011-14-029 or INS011-15-054). Of the 61
patients that enrolled in one of these studies, 25 continue to
receive CBD from INSYS as part of an expanded access program that
ensures continued supply of this investigational drug.
The company’s clinical research on CBD, a non-psychoactive
component of cannabis, includes three ongoing trials: childhood
absence epilepsy (Phase 2), infantile spasms (Phase 3) and
Prader-Willi syndrome (Phase 2). Results from the Phase 2 trial in
childhood absence epilepsy are expected soon, pending completion of
enrollment. All three trials are actively enrolling patients.
In addition, INSYS has formed collaborative research
partnerships with leading academic institutions to advance the
medical science of pharmaceutical cannabinoids in other disease
states, including autism, early psychosis and anxiety in anorexia
nervosa with the University of California San Diego’s Center for
Medicinal Cannabis Research, and cocaine addiction with the
University of Montreal and the Canadian Institutes of Health
Research.
About INSYS
INSYS Therapeutics is a specialty pharmaceutical company that
develops and commercializes innovative drugs and novel drug
delivery systems of therapeutic molecules that improve patients’
quality of life. Using proprietary spray technology and
capabilities to develop pharmaceutical cannabinoids, INSYS is
developing a pipeline of products intended to address unmet medical
needs and the clinical shortcomings of existing commercial
products. INSYS is committed to developing medications for
potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome,
opioid addiction and overdose, and other disease areas with a
significant unmet need.
Forward-Looking Statements
This news release contains forward-looking statements based on
management’s expectations and assumptions as of the date of this
news release. Actual results may differ materially from those in
these forward-looking statements as a result of various factors,
many of which are beyond our control. These factors include, but
are not limited to, risks described in our filings with the United
States Securities and Exchange Commission, including those
discussed under the caption “Risk Factors” in our Annual Report on
Form 10-K for the year ended Dec. 31, 2017 and subsequent updates
that may occur in our Quarterly Reports on Form 10-Q.
Forward-looking statements speak only as of the date of this news
release, and we undertake no obligation to publicly update or
revise these statements, except as may be required by law.
CONTACT: |
Corporate
Communications |
Investor
Relations |
|
Joe McGrath |
Jackie Marcus or Chris
Hodges |
|
INSYS Therapeutics |
Alpha IR Group |
|
480-500-3101 |
312-445-2870 |
|
jmcgrath@insysrx.com |
INSY@alpha-ir.com |
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