New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
August 12, 2014
07:48 EDTINSYInsys Therapeutics submits NDA for new formula of Dronabinol Oral Solution
Insys Therapeutics announced it has submitted a New Drug Application to the FDA for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol, or THC. Upon completion of the Phase III trial: Insys' Dronabinol Oral Solution demonstrated bioequivalence by using 4.25 mg of oral solution versus 5 mg of Marinol, suggesting patients may achieve similar clinical benefits with a lower dose of THC. All patients who took the oral solution achieved detectable plasma levels at 15 minutes, while less than 25% of Marinol patients achieved detectable plasma levels over the same duration. It took four hours for all Marinol subjects to achieve detectable plasma levels. The dronabinol oral solution compared to the Marinol arm also showed less intra patient variability by over 60 percent when measuring total patient exposure to THC. Insys conducts cannabinoid research and production in the United States at its advanced pharmaceutical-grade manufacturing facility, which is approved by the DEA and inspected by the FDA. The company is expanding its production capabilities to include an additional facility to meet anticipated demand once the FDA approves its pipeline products.
News For INSY From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
October 16, 2014
09:02 EDTINSYInsys Therapeutics weakness creates buying opportunity, says JMP Securities
Subscribe for More Information
October 15, 2014
18:26 EDTINSYOn The Fly: After Hours Movers
Subscribe for More Information
16:34 EDTINSYInsys Therapeutics receives DEA approval to produce pharmaceutical Cannabidiol
Insys Therapeutics announced that its FDA inspected and Drug Enforcement Agency approved facility in Round Rock, Texas, has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol. The company has also been granted a quota to produce 15kg of CBD in 2014 and expects a larger quota in 2015 for its continued clinical studies. Insys believes these quantities are sufficient to pursue its CBD development program as currently planned. Insys held a pre-IND meeting with the FDA in September 2014 regarding its development program for CBD in pediatric patients suffering from Dravet Syndrome and Lennox-Gastaut Syndrome, two rare forms of pediatric epilepsy. Insys projects to file an IND in December 2014 for these indications. Babich also noted that Insys has compared its pharmaceutical CBD, which is synthetically produced, with plant-derived CBD obtained from the National Institute on Drug Abuse (NIDA), and found both materials contain an identical chemical structure. "We are pleased that testing in our laboratories has confirmed our long-standing belief that our pharmaceutical CBD is the chemical structure of plant-derived CBD and we believe our purity levels will provide consistent material in the clinical programs," Babich concluded.
16:31 EDTINSYInsys Therapeutics provides update on Dronabinol Oral Solution NDA
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use