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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
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December 15, 2014
07:12 EDTINSYInsys Therapeutics price target raised to $57 from $53 at RBC Capital
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December 9, 2014
07:12 EDTINSYInsys Therapeutics receives FDA orphan drug designation for LEP-ETU
Insys Therapeutics announced that the FDA has granted orphan drug designation to its Liposome Entrapped Paclitaxel Easy to Use, or LEP-ETU, candidate for the treatment of gastric cancer. LEP-ETU is an improved formulation of paclitaxel, a widely used chemotherapeutic agent. Insys acquired LEP-ETU during its merger in 2010 with NeoPharm.
December 8, 2014
10:35 EDTINSYInsys Therapeutics management to meet with Piper Jaffray
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10:00 EDTINSYOn The Fly: Analyst Initiation Summary
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08:18 EDTINSYInsys Therapeutics initiated with a Buy at Jefferies
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