FDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Cannabidiol (CBD) Oral Solution as Investigational Treatment f...
December 26 2017 - 8:30AM
INSYS Therapeutics, Inc. (NASDAQ:INSY), announced today that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation to the company’s cannabidiol (CBD) oral solution for
the treatment of Prader-Willi syndrome, a rare and complex genetic
disorder characterized by insatiable appetite in children that
often leads to obesity and type 2 diabetes.
“FDA’s Fast Track designation will enable an expedited
regulatory review process for our proprietary formulation of CBD in
the treatment of pediatric patients with Prader-Willi syndrome, a
debilitating condition which currently does not have any approved
products available,” said Steve Sherman, senior vice president of
regulatory affairs for INSYS Therapeutics. “We plan to start the
clinical development program for this promising therapy in late
first quarter of 2018.”
The most common known genetic cause of life-threatening obesity
in children, Prader-Willi syndrome has a prevalence of
approximately 1 in 15,000, according to the Prader-Willi Syndrome
Association, occurring in males and females equally and in all
races.
“We are very encouraged by the FDA’s decision to put CBD for
Prader-Willi on the Fast Track and believe it is good news for
these young patients, their families and clinicians,” said Saeed
Motahari, president and chief executive officer of INSYS
Therapeutics. “This special regulatory designation represents a
significant milestone in the company’s R&D program, which is
focused on developing and delivering safe, effective and novel
treatment options using cannabinoids and novel drug delivery
technology for unmet medical needs.”
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.
Forward-Looking Statements This news
release contains forward-looking statements including regarding (i)
our belief that FDA’s Fast Track designation will enable an
expedited regulatory review process for our proprietary formulation
of CBD in the treatment of pediatric patients with Prader-Willi
syndrome, (ii) our belief that Prader-Willi syndrome currently does
not have any approved products available and that our proprietary
CBD formulation has potential to be a viable treatment option and
(iii) our plan to start the clinical development program for this
promising therapy in late first quarter of 2018. 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.
CONTACT:
Media RelationsJoe McGrathCorporate CommunicationsINSYS
Therapeutics480-500-3101jmcgrath@insysrx.com
Investor RelationsJackie Marcus or Chris HodgesAlpha IR
Group312-445-2870 INSY@alpha-ir.com
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