SCOLR Commences CDT(R)-Ondansetron and Phenylephrine Testing.BELLEVUE, Wash. -- SCOLR Pharma, Inc. (AMEX AMEX See: American Stock Exchange : DDD DDD Direct Distance Dialing DDD Digital/Digital/Digital (audio CD format, recording/mixing/mastering) DDD Degenerative Disc Disease DDD Domain Driven Design DDD Data Display Debugger (GNU Project) ) announced today that it has initiated pilot 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. testing in Canada of its refined once-daily CDT CDT abbr. Central Daylight Time CDT Central Daylight Time CDT n abbr (US) (= Central Daylight Time) → hora de verano del centro; (BRIT [R]-ondansetron and its 12-hour CDT[R]-phenylephrine tablets. Results from both trials are expected in early 2007. Authorized by the Therapeutics Products Directorate, Health Canada, both trials involve 32 subjects. Each trial is 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. four way cross-over, open label study in fasted healthy adults. The Company is comparing three revised formulations of its potential once-daily CDT-ondansetron tablets to three immediate release 8 milligram milligram /mil·li·gram/ (mg) (mil´i-gram) one thousandth (10-3) of a gram. mil·li·gram n. Abbr. mg A metric unit of mass equal to one thousandth (10-3) of a gram. (mg) Zofran[R] controls taken over a 24 hour period. SCOLR Pharma is also comparing three initial formulations of its 12-hour CDT-phenylephrine tablets to three immediate release 10 mg. Sudafed[R] PE controls taken over a 12 hour period. Stephen J. Turner, SCOLR's Chief Technology Officer, said, "The initiation of these trials represent the attainment of additional important milestones for our expanding portfolio of CDT-based product candidates. Our once-daily CDT-ondansetron formulation efforts are intended to provide us with a future product opportunity in the growing Cancer Therapy market. Our initial extended release CDT-phenylephrine formulations are intended to form the basis of a potential family of more convenient, over-the-counter allergy and cough cold medications." Ondansetron hydrochloride is the active ingredient in Zofran[R], GlaxoSmithKline's drug to prevent chemotherapy and radiation related nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. . In 2005, GlaxoSmithKline reported over $1.5 billion in global Zofran[R] sales. Commercially available Zofran 8 mg. tablets will serve as the controls for SCOLR Pharma's CDT-ondansetron study. Phenylephrine phenylephrine /phen·yl·eph·rine/ (-ef´rin) an adrenergic used as the hydrochloride salt for its potent vasoconstrictor properties. phen·yl·eph·rine n. is an alternative ingredient that can be used in place of pseudoephedrine pseudoephedrine /pseu·do·ephed·rine/ (-e-fed´rin) one of the optical isomers of ephedrine; used as the hydrochloride or sulfate salt as a nasal decongestant. pseu·do·e·phed·rine n. . Phenylephrine is the active ingredient in Sudafed[R] PE, an immediate release Pfizer OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). decongestant decongestant /de·con·ges·tant/ (de?kon-jes´tint) 1. tending to reduce congestion or swelling. 2. an agent that so acts. de·con·ges·tant n. product for upper respiratory discomfort. Phenylephrine is also the active ingredient in many new private label store brand products for similar indications. The domestic OTC decongestant market is estimated to exceed $1 billion annually. Commercially available 10 mg. Sudafed[R] PE tablets will serve as controls for SCOLR's CDT-Phenylephrine study. About SCOLR Pharma: Based in Bellevue, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company leveraging formulation expertise and its patented CDT platform to introduce distinctive and novel OTC products, prescription drugs and dietary supplements. SCOLR Pharma's CDT drug delivery platform provides distinctive products with tangible benefits for the consumer and competitive commercial advantages for licensees. For more information on SCOLR Pharma, please call (425) 373-0171 or visit http://www.scolr.com/ This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products. And we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances. |
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