INSYS Therapeutics (INSY) Initiates Phase 2 Clinical Trial of Cannabidiol (CBD) Oral Solution

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INSYS Therapeutics Initiates Phase 2 Clinical Trial of Cannabidiol (CBD) Oral Solution for Treatment of Refractory Childhood Absence Epilepsy in Pediatric Patients

Can a synthetic formulation of cannabidiol (CBD), one of the main molecules in cannabis, safely help control treatment-resistant “staring” seizures in children with epilepsy? Working with pediatric patients who suffer from this debilitating condition and their clinicians, INSYS Therapeutics (INSY) plans to find out by conducting a study using its pharmaceutical-grade, synthetic CBD.

The company today announced the initiation of a new clinical trial of CBD oral solution—a Phase 2, open-label, dose-finding study (INS011-17-103) that aims to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of the novel product candidate—for refractory childhood absence epilepsy in pediatric patients.

INSYS previously completed a two-part clinical trial (INS011-14-029 and -030) of CBD oral solution for treatment of refractory pediatric epilepsy, with encouraging results. A majority of the patients in these sequentially conducted Phase 1/2 PK and long-term safety studies experienced a reduction in seizure frequency and/or intensity while receiving CBD oral solution. Initial results from these studies, which continue under the company’s “Compassionate Use” program, were presented earlier this month at the 2017 annual meeting of the American Epilepsy Society in Washington, D.C.

Of the more than 470,000 children in the United States who have been diagnosed with epilepsy, an estimated 2–8 percent of these patients have experienced absence seizures, according to the Centers for Disease Control and Prevention (CDC) and the Epilepsy Foundation.

“Treatment options for pediatric epilepsy patients with refractory childhood absenceseizures are limited and inadequate,” explained Dr. Steven Phillips, a pediatric neurologist at Mary Bridge Children’s Hospital and Health Center in Tacoma, Wash., and an investigator in the new study.
“Better treatments with greater efficacy and fewer side effects are needed to improve quality of life and clinical outcomes for these patients. CBD holds great promise for this challenging form of epilepsy, and we are excited to be involved in another study of this particularly promising formulation of CBD from INSYS.” (Dr. Phillips also served as an investigator in the previous CBD studies sponsored by INSYS.)

“We are very excited to begin our clinical development program of CBD in refractory childhood absence epilepsy,” said Steve Sherman, senior vice president of regulatory affairs at INSYS Therapeutics. “We believe that CBD might be able to offer these children a new alternative when traditional therapies have not been effective or well tolerated. This clinical program demonstrates our ongoing commitment to addressing unmet medical needs in rare diseases and furthers our position as a pioneer in the emerging field of pharmaceutical-grade medicinal cannabinoids.”

The study is expected to be completed in late 2018.

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 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 (i) expectations as to when study results will be available or presented and (ii) belief that CBD might be able to offer these children a new alternative when traditional therapies. 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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