ProEthic Pharmaceuticals Initiates Pivotal Phase III Trial for Fast-Acting Migraine Product Candidate; Trial to be conducted under Special Protocol Assessment.MONTGOMERY, Ala. -- ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops and markets niche prescription products, announced today that it has initiated a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for PRO-513, the company's product candidate for the treatment of migraine headaches. The study is being conducted under the guidance of a Special Protocol Assessment (SPA) provided by the U.S. Food and 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. ). The SPA indicates that if the trial successfully meets its primary endpoints, the data will provide the basis for an efficacy claim in a marketing application to the FDA. PRO-513 is a formulation of diclofenac potassium di·clo·fen·ac potassium n. A nonsteroidal anti-inflammatory drug used to treat pain. diclofenac potassium Cataflam, Novo-Difenac-K (CA), Novo-Difenac-SR (CA) Pharmacologic class: powder for oral solution, which utilizes a unique, patented Dynamic Buffering Technology (DBT DBT Department of Biotechnology (India) DBT Dibenzothiophene DBT Drive-By Truckers (band) DBT Design Basis Threat DBT Deutscher Bundestag (German Parliament) ) that has been demonstrated to enhance the pharmacokinetic profile of diclofenac. This new formulation is expected to offer migraine headache patients rapid pain relief combined with superior efficacy and tolerability. In a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind clinical trial, PRO-513 has been shown to provide systematic improvement of migraine symptoms within 15 minutes. "PRO-513, and its unique formulation of diclofenac, represents a potentially new and improved treatment option for the 28 million Americans who experience debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction migraine headaches," said Carl Whatley, Chairman 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. of ProEthic Pharmaceuticals, Inc. "We are excited to be able to develop a product with strong potential advantages not only in safety and efficacy, but one that can offer the rapid relief that migraine sufferers so desperately seek." About the IMPACT Trial The Phase III trial for PRO-513, identified as the International Migraine Pain Assessment Clinical Trial (IMPACT), will enroll 650 patients in approximately 21 centers over the next eight months. The IMPACT trial is a multi-center, prospective, randomized, double-blind, parallel group, single dose, placebo-controlled study of the efficacy and safety of PRO-513 in adult subjects with migraine attacks. The primary endpoints for the trial are: pain relief, nausea, photophobia photophobia /pho·to·pho·bia/ (-fo´be-ah) abnormal visual intolerance to light.photopho´bic pho·to·pho·bi·a n. 1. , and phonophobia. ProEthic anticipates filing a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for PRO-513 in early 2007 and expects to introduce the product in the U.S. in early 2008. About PRO-513 In 2005, ProEthic obtained exclusive U.S. and Canadian marketing rights for PRO-513 from Applied Pharma Research, a Swiss drug development company. Additionally, ProEthic has obtained the rights to utilize PRO-513 clinical trial data from Novartis Pharmaceuticals. In the Phase III migraine study conducted by Novartis, PRO-513 was shown to be safe and effective in the treatment of migraine pain and symptoms associated with migraine, namely photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea. Novartis recently obtained marketing approval for the product, under the trademark Voltfast(R), in Switzerland and Portugal and is expecting approvals in over two dozen other European countries in 2006. About ProEthic Pharmaceuticals, Inc. ProEthic is a privately funded specialty pharmaceutical company that acquires, develops and markets niche prescription products. ProEthic markets branded prescription allergy, respiratory, pain and men's prostate vitamin products to general and family practitioners and selected specialty physicians in rural and suburban markets in 31 states. The company develops and commercializes proprietary formulations of previously approved compounds and selectively seeks regulatory approval to market well-characterized compounds for new therapeutic indications. ProEthic has built its product portfolio and development pipeline through a combination of internal development and acquisition of late-stage drug candidates. It also markets niche generic prescription pharmaceutical products through Midlothian Laboratories LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. . For more information, please visit the ProEthic website at: www.proethic.com. |
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