INSYS Therapeutics Initiates Phase 3 Clinical Trial of Cannabidiol (CBD) Oral Solution for Treatment of Infantile Spasms
March 02 2018 - 8:30AM
INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the
development, manufacture and commercialization of pharmaceutical
cannabinoids and spray technology, today announced the initiation
of a Phase 3 clinical trial to study cannabidiol (CBD) oral
solution for the treatment of infantile spasms, a rare type of
pediatric epilepsy that occurs in very young children, with the
first trial site’s activation.
“We need better treatments for infantile spasms, one of the more
severe and dangerous seizure disorders of early childhood,” said
Shaun Hussain, M.D., a pediatric neurologist at UCLA Mattel
Children’s Hospital and director of its Infantile Spasms Project.
“That’s why we’re excited about this pivotal study, which has the
potential to reveal a new piece of the treatment puzzle for
infantile spasms.”
In previous studies, CBD—one of the main molecules in
cannabis—has demonstrated sustained clinical benefits in a variety
of medically refractory pediatric epilepsies, including infantile
spasms, an uncommon condition estimated by the Child Neurology
Foundation (CNF) to be diagnosed in about 1,200 children in the
United States each year.
“We have great hope in the potential of our proprietary
formulation of pharmaceutical-grade, synthetically manufactured CBD
oral solution in combination with vigabatrin to offer greater
seizure control to children with infantile spasms,” said Steve
Sherman, senior vice president of regulatory affairs for INSYS
Therapeutics. “The need for more efficacious and better tolerated
products to treat this devastating disorder continues to motivate
us to advance this investigational therapy through the clinical and
regulatory pathway.”
According to the Infantile Spasms Action Network (ISAN), a
collaborative advocacy network of 25 national and international
organizations convened by CNF, infantile spasms have an average age
of onset of around four months, although in some cases the first
seizure occurs as early as one month or as late as two years. In
most cases, infantile spasms appear to be slight head drops, which
belie the seriousness of the condition. Evidence shows that
infantile spasms are a more serious seizure disorder than
generalized convulsions.
INSYS Therapeutics recently became a member of ISAN, which hosts
an annual awareness and education initiative, Infantile Spasms
Awareness Week (ISAW), held Dec. 1–7.
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 is committed to developing medications
for potentially treating addiction to opioids, opioid overdose,
epilepsy, and other disease areas with a significant unmet
need.
Forward-Looking Statements This news
release contains forward-looking statements including our belief
regarding the potential of our investigational CBD oral solution to
become an effective treatment for infantile
spasms. These 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.
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CONTACT: |
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Corporate
Communications |
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Investor
Relations |
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Joe McGrath |
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Jackie Marcus or Chris
Hodges |
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INSYS Therapeutics |
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Alpha IR Group |
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480-500-3101 |
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312-445-2870 |
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jmcgrath@insysrx.com |
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INSY@alpha-ir.com |
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