Blog Exposure – INSYS Commences Phase-2 Clinical Trial of Cannabidiol Oral Solution for Treatment of Prader-Willi Syndrome
Active-Investors.com has just released a free research report on INSYS Therapeutics, Inc. (NASDAQ: INSY) (“INSYS”). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=INSY as the Company’s latest news hit the wire. On April 27, 2018, the Company announced that it has initiated a Phase-2 clinical trial assessing its cannabidiol (CBD) oral solution for the potential treatment of pediatric patients with Prader-Willi syndrome, which is a rare genetic disease characterized by insatiable appetite in children that often leads to obesity, type 2 diabetes, and premature death. Register today and get access to over 1000 Free Research Reports by joining our site below:
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Phase-2 Trial Results Expected in Q4 2019
INSYS’ Phase-2 study will measure the effect of its propriety CBD oral solution on the behavior related to hyperphagia, which is defined as an abnormally increased appetite for and consumption of food, in patients with Prader-Willi syndrome. The trial will enroll approximately 66 subjects, aged between 8 to 17 years, at 10 clinical sites in the United States, with results expected in Q4 2019.
CBD has the Potential to be an Important Addition to Limited Range of Treatment Options for Prader-Willi Syndrome
Steve Sherman, Senior Vice President of Regulatory Affairs for INSYS, mentioned that while Prader-Willi syndrome presents a complex constellation of symptoms to address, the Company’s study will focus on one of the most challenging symptoms, hyperphagia. Sherman added that INSYS’ formulation of CBD has the potential to be an important addition to the limited range of treatment options for this condition.
FDA Granted Fast Track Designation for Cannabidiol as Investigational Treatment for Prader-Willi Syndrome
On December 26, 2018, the US Food and Drug Administration (FDA) granted a Fast Track designation to cannabidiol (CBD) oral solution for the treatment of Prader-Willi syndrome. The FDA’s Fast Track designation will enable an expedited regulatory review process for proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome.
INSYS Initiated Phase-3 Clinical Trial of Cannabidiol for Treatment of Infantile Spasms
On March 02, 2018, the Company began a Phase-3 clinical trial to study cannabidiol (CBD) oral solution for the treatment of infantile spasms, a rare type of pediatric epilepsy that occurs in very young children, with the first trial site’s activation. In previous studies, CBD, one of the main molecules in cannabis, has demonstrated sustained clinical benefits in a variety of medically refractory pediatric epilepsies, including infantile spasms.
About Prader-Willi Syndrome
Prader-Willi syndrome is a genetic disorder due to the loss of function of specific genes. It is known as a two-stage syndrome, with the first stage characterized by hypotonia (low muscle tone) and poor feeding in infancy, and the second stage exhibiting hyperphagia (an uncontrollable drive to eat), combined with weight gain on fewer calories. Beginning in childhood, the person becomes constantly hungry which often leads to obesity and type 2 diabetes. There is also typically mild to moderate intellectual impairment and behavioral problems. Prader-Willi syndrome has no cure.
About INSYS Therapeutics, Inc.
Founded in 1998 and headquartered in Chandler, Arizona, INSYS is a commercial-stage specialty pharmaceutical Company that develops and commercializes innovative supportive care products to address chemotherapy-induced nausea and vomiting (CINV), pain management, and other central nervous system disorders.
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