QUESTCOR INITIATES QSC-001 CLINICAL PROGRAM.Questcor Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :QSC), Union City, Calif., has initiatedpatient dosing under its investigational new drug (IND) application with the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for QSC-001, a unique orally disintegrating tablet The Food and Drug Administration's (FDA) definition of an orally disintegrating tablet (ODT) is: "A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. (ODT) formulation of hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen Warning - High-alert drug! Anexsia, Ceta-Plus, Co-Gesic, Hydrocet, Lorcet-HD, Lortab, Vicodin, Vicodin HP Pharmacologic class: (HB/APAP) for the treatment of moderate to moderately severe pain. QSC-001 was formulated for Questcor by Eurand and will utilize Eurand's proprietary Microcaps taste-masking and AdvaTab ODT technologies. Questcor owns the world-wide rights to commercialize QSC-001 and Eurand will exclusively supply the product and receive a royalty on product sales. HB/APAP, in its variety of strengths, is one of the most frequently prescribed products in the United States with over 100 million prescriptions written in the past year according to Wolters Kluwer. HB/APAP is one of the five most frequently prescribed products by Neurologists, who accounted for over one million prescriptions. There are currently no ODT formulations of HB/APAP available in the United States. "The successful initiation of our first clinical development program represents an important milestone in Questcor's evolution into a leading CNS-focused specialty pharmaceutical company. We believe that QSC-001 could fill a critical gap in the treatment of pain and represents a tremendous opportunity for Questcor," commented James Fares, Questcor's president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Neurologists prescribe pain medication for a large number of their patients, particularly those with Multiple Sclerosis, Headache, Chronic Pain, and Spinal lesions. For the many individuals who experience significant difficulty swallowing pills, we believe QSC-001 represents a valuable option for the treatment of their pain." Questcor expects to file the QSC-001 New Drug Application with the FDA in the second half of 2007. Eurand will receive milestone payments upon the achievement of certain development milestones. About Eurand's ODT Technology: AdvaTab can be combined with Eurand's Microcaps[R] taste-masking technology to provide an ODT with a pleasant taste. In addition, AdvaTab tablets dissolve rapidly in the mouth within 15 to 30 seconds, and the smooth mixture of carrier excipients excipients, n.pl all the constituents of a remedy that lack medicinal properties. See also adjuvant, auxiliary substance, and vehicle. and taste-masked drug granules Granules Small packets of reactive chemicals stored within cells. Mentioned in: Allergic Rhinitis, Allergies is suitable for delivering high drug doses. Modified-release drug granules can also be incorporated into the AdvaTab dosage form to provide a fast-dissolve tablet with sustained-release properties. AdvaTab tablets can be packaged in either bottles or blisters. About Eurand: Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. The company has had three products approved by the FDA since 2001 and has a pipeline of products in development both for its co-development partners and its proprietary portfolio. The company's lead product candidate, a treatment for exocrine pancreatic insufficiency Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. This disease is found frequently in dogs. EPI is also found in humans afflicted with cystic fibrosis. associated with cystic fibrosis and other diseases, is currently undergoing Phase III clinical trials in the United States. Eurand's technology platforms include: bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. enhancement of poorly soluble drugs, customized release, taste masking/fast-dissolving formulations, and drug conjugation conjugation, in genetics conjugation, in genetics: see recombination. conjugation, in grammar conjugation: see inflection. . Eurand is an established business with manufacturing and research facilities in the United States, Italy and France. For more information, visit http://www.eurand.com. About Questcor Questcor Pharmaceuticals, Inc. (AMEX:QSC) is a specialty pharmaceutical company that develops and commercializes novel therapeutics for the treatment of neurological disorders. Questcor currently markets H.P. Acthar Gel (repository corticotropin corticotropin (kôr'təkōtrōp`ən): see adrenocorticotropic hormone. injection), an injectable drug indicated for the treatment of exacerbations associated with multiple sclerosis and Doral[R] (quazepam), that is indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. For more information, visit http://www.questcor.com or call 510/400-0700. |
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