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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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August 27, 2015
17:08 EDTINSYInsys Therapeutics receives purported service of notice of three IPR petitions
On August 26, Insys Therapeutics received purported service of notice of three inter partes review petitions filed by a hedge fund with the U.S. Patent and Trademark Office, challenging three of the four Orange Book-listed patents covering Subsys. The company intends to oppose the request to institute the IPR and, if any of the three petitions are granted, the company intends to defend the validity of each patent challenged in each IPR.

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