PHOENIX, AZ--(Marketwired - Aug 18, 2015) - Insys Therapeutics, Inc. ("Insys" or "the Company") (NASDAQ: INSY) today announced it has filed a Citizen Petition with the Drug Enforcement Administration ("DEA") to request the agency reschedule its synthetic pharmaceutical cannabidiol ("CBD") from Schedule I to Schedule IV. The Company believes that the current classification of synthetic CBD as a Schedule I compound is a significant barrier to the progress of research studies that explore the value of this compound in the treatment of several serious medical conditions.
"CBD is a non-psychoactive compound found in the marijuana plant that offers the potential to provide a treatment option to patients suffering from a wide variety of diseases," said Steve Sherman, Vice President, Regulatory Affairs, at Insys Therapeutics. "Importantly, Insys's synthetic pharmaceutical CBD is a form of the compound that is identical in chemical structure to naturally-occurring CBD, but because it is not derived from marijuana, it is free of THC and other cannabinoid impurities, ensuring a consistent and controlled dosage with little or no potential for abuse."
Independent comparison analyses conducted by Insys and the National Institute on Drug Abuse, part of the National Institutes of Health, have found that CBD synthetically produced by Insys Therapeutics is identical in chemical structure to plant-derived CBD.
The Citizen Petition to reschedule Insys's synthetic pharmaceutical CBD outlines scientific and medical evidence that demonstrate the Company's synthetic pharmaceutical CBD has no potential for abuse or dependency and, therefore, should be in Schedule IV or lower. More importantly, Insys's synthetic pharmaceutical CBD has the potential to provide new treatment options for a wide variety of diseases, such as epilepsy, brain cancer, schizophrenia, post-traumatic stress disorder, anxiety, Alzheimer's disease, neuropathic pain, Parkinson's disease, diabetes, and many others.
The U.S. Drug Schedule System classifies drugs into five categories, or schedules, based on the drug's acceptable medical use and abuse or dependency potential. Synthetic CBD's classification as a Schedule I drug ranks the compound as similar to drugs such as heroin and cocaine. This means the process for obtaining the necessary approvals to conduct research from the various licensing bodies can take approximately one year, and a substantial commitment is required to execute the paperwork, inspection, and approval process. Outside the United States, effective June 1, 2015, CBD has been classified as a Schedule 4 substance by the Australian Therapeutic Goods Administration, which is the least restrictive schedule for prescription medicines in that country. In the United Kingdom, CBD is classified as a Class B medicinal product, and in Canada, CBD has been classified as a Schedule II medicinal product, both of which are less restrictive than Schedule I drugs in the U.S.
"Insys is asking the DEA to reschedule its synthetic pharmaceutical CBD as part of our continued commitment to advancing the research and development of cannabinoid therapies while striving to provide physicians and patients with consistent and controlled pharmaceutical options that can help improve the quality of life for patients," said Michael Babich, President and Chief Executive Officer. "We are currently engaging with a broad range of stakeholders to build support for this Citizen Petition, in the hopes of addressing serious unmet medical needs."
A Citizen Petition can be filed to ask that a governing agency, like the DEA or U.S. Food and Drug Administration, take, or refrain from taking, a particular action. Any person may file a Citizen Petition, and any person may comment on a petition that has been filed. Insys cannot predict when or if the DEA will respond to, or otherwise take any action with respect to the Citizen Petition filed.
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 addresses the clinical shortcomings of existing commercial products. The Company recently submitted a New Drug Application to the U.S. Food and Drug Administration for 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 developing a pipeline of sublingual sprays, as well as synthetic pharmaceutical cannabidiol.
This press release contains forward-looking statements including related to our belief that (i) the current classification of synthetic CBD as a Schedule I compound is a significant barrier to the progress of research studies, (ii) CBD offers the potential to provide a treatment option to patients suffering from a wide variety of diseases, and (iii) Dronabinol Oral Solution has distinct advantages over the current formulation of dronabinol in soft gel capsule. These forward-looking statements are based on management's expectations and assumptions as of the date of this press 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 December 31, 2014 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 press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.