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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.
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September 24, 2015
07:04 EDTINSYInsys in-licenses cannabinoid inhalation technology
Insys Therapeutics announced that it has entered into an exclusive license agreement and partnership with U.K. based Senzer Ltd. for the development of inhaled synthetic pharmaceutical cannabinoid products including dronabinol and cannabidiol using Senzer's proprietary inhalation delivery technology. Senzer has exclusively licensed all proprietary inhalation delivery technology in the field of Cannabinoid molecules held by Kind Consumer Holdings Limited, a UK based healthcare research and development company focused on inhalation technologies. The Kind Consumer inhalation technology has been recently approved by the Medicines and Healthcare products Regulatory Agency in the United Kingdom as a licensed medicine for smoking cessation. Insys and Senzer will work towards the development of synthetic pharmaceutical THC and CBD inhaled products under the guidance of the U.S. Food and Drug Administration using the same inhalation technology as used in the Voke Inhaler product.
September 23, 2015
08:24 EDTINSYWeakness in drug stocks creates buying opportunities, says RBC Capital
After Hillary Clinton unveiled a plan to lower drug prices, RBC Capital does not expect the plan to be passed by Congress. The firm adds that the plan is positive for generic drug makers and could pressure the FDA to more quickly approve generic drug applications. RBC identifies Insys Therapeutics (IINSY), Endo (ENDP), and Sagent Pharma (SGNT) as three stocks it likes that have suffered "disproportionate selloffs over the last two days." The firm identifies Sagent, Emdo and Mylan (MYL) as three companies with high generic exposure that have sold off.

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