CHANDLER, Ariz., Feb. 15, 2017 (GLOBE NEWSWIRE) -- 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.
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