Insys Therapeutics Receives FDA Orphan Drug Designation
Insys Therapeutics, Inc. recently announced that the US FDA has granted orphan drug designation (ODD) to its Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) candidate for the treatment of gastric cancer. LEP-ETU is an improved formulation of paclitaxel, a widely used chemotherapeutic agent.
“We are pleased to have received orphan drug designation for LEP-ETU to treat gastric cancer, a devastating and difficult-to-treat disease,” said Michael L. Babich, President and Chief Executive Officer. “By entrapping the paclitaxel with liposomes, we believe our LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel. We are currently evaluating next steps with respect to this drug product candidate.”
Insys acquired LEP-ETU during its merger in 2010 with NeoPharm. Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the US. The designation provides the drug developer with a 7-year period of US marketing exclusivity upon approval, as well as certain financial incentives that can help support its development.
Paclitaxel is an anti-microtubular network agent and is active in a broad spectrum of malignancies. To enhance its poor solubility, paclitaxel is formulated with or bound to a delivery vehicle. Taxol is formulated with ethanol and Cremophor EL, a polyethoxylated castor oil that leads to infusion-related hypersensitivity reactions. In Abraxane, paclitaxel is bound to albumin nanoparticles.
Gastric cancer is the fifth most common cancer in the world, and the third-leading cause of cancer death. In the US, it is estimated that approximately 22,000 people will be diagnosed with gastric cancer in 2014.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using its proprietary sublingual spray technology and its capability to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets two products, Subsys, which is sublingual Fentanyl spray for breakthrough cancer pain, and a generic version of Dronabinol (THC) capsules. The company’s lead product candidate is Dronabinol Oral Solution, a proprietary orally administered liquid formulation of dronabinol. Insys is also developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol. For more information, visit www.insysrx.com.
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