INSYS Therapeutics Extends ‘Compassionate Use’ Studies of Cannabidiol (CBD) for Refractory Pediatric Epilepsy
October 09 2017 - 9:00AM
INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”),
announced today that it has extended the compassionate use studies
of its proprietary oral formulation of cannabidiol (CBD) for the
treatment of refractory pediatric epilepsy, enabling patients from
previous clinical trials of the investigational medicine to
continue receiving it according to the protocols originally
accepted by the U.S. Food and Drug Administration (FDA) and under
the supervision of their physicians.
The original 48-week expanded access program followed a
long-term safety study that permitted patients who had completed
the initial 10-day safety and pharmacokinetics (PK) study to
continue receiving the company’s CBD oral solution at doses up to
40 mg/kg/day for up to 48 weeks. In the initial safety and PK
study, 61 patients with refractory epilepsy between the ages of 1
and 17 years received total daily doses of 10 mg/kg, 20 mg/kg or 40
mg/kg. Of these 61 patients, 52 continued into the long-term safety
study, of which 45 have completed 48 weeks of treatment across
multiple investigative sites in the United States.
Expanded access, also called “compassionate use,” provides a
pathway for patients to gain access to investigational medicines
before they are approved by the FDA.
Approximately 31 of the 45 patients in the long-term safety
study of INSYS Therapeutics’ CBD oral solution for refractory
pediatric epilepsy have enrolled in the expanded access program,
including 12 under the care of Dr. Steven Phillips, M.D., a
pediatric epileptologist affiliated with MultiCare Mary Bridge
Children’s Hospital and Health Center and MultiCare Tacoma General
Hospital in Tacoma, Wash.
“All 12 of our families are extremely grateful that they
continue to get CBD for their children through the expanded access
program for CBD from INSYS Therapeutics,” said Dr. Phillips, who is
a principal investigator in the compassionate use
studies. “Seizure control has continued to be much improved on
CBD as compared to when not on CBD, and this effect has been
maintained for several years. As importantly, we have seen
minimal side effects with CBD and an overall improvement in the
quality of life in our patients.”
INSYS decided to extend the expanded access program as a result
of the patients’ continued response to treatment with the company’s
formulation of CBD oral solution.
“We are delighted that children with a history of intractable
seizures are benefiting from our investigational CBD oral
solution,” said Saeed Motahari, president and chief executive
officer of INSYS Therapeutics. “We admire and respect these brave
kids and their parents for taking part in our early trials, which
are among the first in this emerging area of medicine for
refractory pediatric epilepsy. We also appreciate the tireless
efforts of the pediatric epileptologists involved in the initial
studies, which we believe will inform our future research on this
novel compound.”
About INSYSINSYS 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 intending to address
unmet medical needs and the clinical shortcomings of existing
commercial products. INSYS currently markets SUBSYS® (fentanyl
sublingual spray), CII, and SYNDROS® (dronabinol) oral solution,
CII, a proprietary, orally administered liquid formulation of
dronabinol. INSYS is committed to developing medications for
potentially treating addiction to opioids, opioid overdose,
epilepsy, and other disease areas with a significant unmet
need.
SUBSYS® and SYNDROS® are trademarks of INSYS Development
Company, Inc., a subsidiary of INSYS Therapeutics, Inc.
NOTE: All trademarks and registered trademarks are the property
of their respective owners.
Forward-Looking Statements This news
release contains forward-looking statements including the belief
that the above referenced studies will inform our future research
on this novel compound. Forward looking statements are 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, risk factors described in our filings with the
United States Securities and Exchange Commission, including those
factors discussed under the caption “Risk Factors” in our Annual
Report on Form 10-K for the year ended Dec. 31, 2016 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:
Media RelationsJoe McGrathSenior Director, Corporate
CommunicationsINSYS
Therapeutics480-500-3101jmcgrath@insysrx.com
Investor RelationsJackie Marcus or Chris HodgesAlpha IR
Group312-445-2870 INSY@alpha-ir.com
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