INSYS Therapeutics Inc (NASDAQ:INSY) reported that the U.S. FDA has allowed Fast Track designation to the firm’s cannabidiol oral solution for the cure of Prader-Willi syndrome. Steve Sherman, the SVP of regulatory affairs, expressed that FDA’s Fast Track status will allow an expedited regulatory review procedure for their formulation of Cannabidiol in the treatment of pediatric subjects with Prader-Willi syndrome.
Prader-Willi is a debilitating problem which presently does not have any permitted products available. They intend to begin the clinical advancement plan for this promising treatment in Q1 2018. The most prevalent known genetic cause of grave obesity in kids, Prader-Willi syndrome has an occurrence of around 1 in 15,000, as per the Prader-Willi Syndrome Association, happening in females and males equally as well as in all races.
Saeed Motahari, the CEO and President of INSYS Therapeutics, expressed that they are extremely encouraged by the U.S. FDA’s decision to put Cannabidiol for Prader-Willi on the Fast Track status and consider it is promising news for these patients, their families as well as for clinicians. This special regulatory status exhibits a notable milestone in the firm’s Research & Development plan, which is focused on advancing and offering effective, novel and safe treatment alternatives utilizing cannabinoids and unique drug delivery know-how for unmet medical needs.
INSYS Therapeutics marks as a specialty pharmaceutical entity that develops and markets unique drugs and innovative drug delivery mechanisms of therapeutic molecules that enhance patients’ quality of life. Utilizing proprietary spray technology as well as capabilities to develop pharma cannabinoids, the firm is working on a pipeline of products planned to resolve the clinical shortcomings of current commercial products and unmet medical needs.
In the last trading session, the shares price of Insys dropped 26.31% to end the day at $9.86. The drop came at a share volume of 6.90 million compared to average share volume of 1.09 million.