Insys Therapeutics

Analyses Show Insys’ Synthetic CBD is Chemically Identical to the Plant-Derived CBD

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Specialty pharmaceutical company, Insys Therapeutics, Inc. recently announced that analyses determined that its synthetic cannabidiol (CBD) is chemically identical to the plant-derived CBD.

The determination was made by comparison analyses, which were conducted independently by Insys and the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). In order to conduct the comparison analyses, both Insys and NIDA utilized NIDA-supplied natural, plant-derived CBD and synthetically produced CBD supplied by Insys.

The two separately-conducted analyses ascertained that Insys’ synthetically produced CBD:

  • Has identical identity and chemical structure to plant-derived CBD;
  • Has identical stereochemistry to plant-derived CBD, with both demonstrating the same (-) CBD enantiomer with no (+) enantiomer present, which was confirmed by Chiral Assay;
  • Is more pure, with a two percent higher CBD Assay value than plant-derived CBD;
  • Insys CBD total HPLC purity 99.9 percent vs. plant-derived CBD at 98.7 percent; and,
  • Meets all ICH impurity guidelines, with no impurities greater than 0.10 percent, vs. plant-derived CBD which contained multiple impurities above ICH guidelines.

“These results of NIDA’s analyses confirm those conducted in our laboratories, demonstrating that our CBD is identical in chemical structure to plant-derived CBD as determined by multiple methods,” said Michael L. Babich, President and Chief Executive Officer of Insys. “We believe our product’s purity levels will provide consistent material for our clinical programs, including our program to evaluate CBD in pediatric patients suffering from Dravet Syndrome and Lennox-Gastaut Syndrome. We plan to dose our first human subjects in the first quarter of 2015 in a Phase I setting.”

Insys’ synthetic, pharmaceutical CBD is produced under cGMP conditions at its FDA-inspected and Drug Enforcement Administration (DEA)-approved facility in Round Rock, Texas. The company said that its facility allows for manufacturing CBD at greater batch-to-batch consistency and uniformity. The company believes that it is the only US-based company that is capable of producing pharmaceutical cannabinoids in scalable quantities.

Insys has been approved as a qualified supplier of CBD to NIDA, and NIDA will refer CBD requests directly to Insys.

Source: Insys Therapeutics, Inc.

Last updated: 12/9/14; 2:00pm EST