Insys Therapeutics Announces Use of Cannabidiol Oral Solution for Compassionate Use Studies in Patients Completing Long-Term ...
February 15 2017 - 7:00AM
Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company")
today announced that the Company is providing for the use of
Cannabidiol Oral Solution at doses up to 40 mg/kg/day in
compassionate use studies in subjects with refractory pediatric
epilepsy following completion of 48 weeks of treatment in the
ongoing long-term safety study. The long-term safety study
permitted subjects who had completed the initial safety and
pharmacokinetic (PK) study to receive Cannabidiol Oral Solution at
doses up to 40 mg/kg/day for up to 48 weeks. In the initial
safety and PK study, 61 subjects with refractory epilepsy, between
the ages of one and 17 years, received total daily doses of 10
mg/kg, 20 mg/kg or 40 mg/kg. In nine of the 61 subjects where
Delta-9-THC was measured, no quantifiable plasma levels of
Delta-9-THC were detected. Cannabidiol Oral Solution was generally
well tolerated.
From the initial safety and PK study, 53 subjects continued into
the long-term safety study, of which 15 subjects have completed 48
weeks of treatment with Cannabidiol Oral Solution across multiple
investigative sites in the United States.
“We are pleased that investigators have deemed it appropriate to
continue patients on Cannabidiol Oral Solution beyond 48 weeks of
treatment and we remain dedicated to making our product available
to them,” said Dr. Santosh Vetticaden, Insys’ Interim CEO, and
Chief Medical Officer.
Cannabidiol Oral Solution for the compassionate use studies is
being provided at no cost to patients or investigators. Currently,
several investigators have received FDA approval for compassionate
use and have patients currently enrolled in this
program.
“I am pleased that Insys is making Cannabidiol Oral Solution
available on a compassionate use basis and I look forward to
participating in this program,” stated Maria Roberta Cilio, MD, PhD
at the University of California, San Francisco Pediatric Epilepsy
Center and an investigator participating in the Company’s long-term
safety study.
Expanded access, also called “compassionate use,” provides a
pathway for patients to gain access to investigational drugs (i.e.,
one that has not been approved by FDA).
About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that
develops and commercializes innovative drugs and novel drug
delivery systems of therapeutic molecules that improve the quality
of life of patients. Using proprietary sublingual spray technology
and capabilities to develop pharmaceutical cannabinoids, Insys is
developing a pipeline of products intending to address unmet
medical needs and the clinical shortcomings of existing commercial
products. Insys currently markets one product, SUBSYS® (fentanyl
sublingual spray) but has received approval for the marketing of
SYNDROS™ (dronabinol oral solution), a proprietary, orally
administered liquid formulation of dronabinol that Insys believes
has distinct advantages over the current formulation of dronabinol
in soft gel capsule. Insys is committed to developing
medications for potentially treating addiction to opioids, opioid
overdose, epilepsy, and other disease areas with high unmet
need.
SUBSYS® and SYNDROS™ are trademarks of Insys Development
Company, Inc., a subsidiary of Insys Therapeutics, Inc.
Contact:
Lisa Wilson
T: 212-452-2793
E: lwilson@insitecony.com
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