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.”
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 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.
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.
Senior Director, Corporate Communications
Jackie Marcus or Chris Hodges
Alpha IR Group
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