PHOENIX, Dec. 26, 2017 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ:INSY), announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s cannabidiol (CBD) oral solution for the treatment of Prader-Willi syndrome, a rare and complex genetic disorder characterized by insatiable appetite in children that often leads to obesity and type 2 diabetes.
“FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, a debilitating condition which currently does not have any approved products available,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “We plan to start the clinical development program for this promising therapy in late first quarter of 2018.”
The most common known genetic cause of life-threatening obesity in children, Prader-Willi syndrome has a prevalence of approximately 1 in 15,000, according to the Prader-Willi Syndrome Association, occurring in males and females equally and in all races.
“We are very encouraged by the FDA’s decision to put CBD for Prader-Willi on the Fast Track and believe it is good news for these young patients, their families and clinicians,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “This special regulatory designation represents a significant milestone in the company’s R&D program, which is focused on developing and delivering safe, effective and novel treatment options using cannabinoids and novel drug delivery technology for unmet medical needs.”
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 intended to address unmet medical needs and the clinical shortcomings of existing commercial products.