BioDelivery Sciences Confirms Dose Proportionality with BEMA(TM) Fentanyl.MORRISVILLE, N.C. -- BioDelivery Sciences International, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BDSI BDSI Brooks Divinity School, Inc (Denver, CO) ), a specialty biopharmaceutical company, announced the results of a pharmacokinetic study with BEMA(TM) Fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and . The study demonstrated that both peak plasma fentanyl concentrations and overall exposure increase in a linear manner (i.e., in proportion to the dosage dosage /dos·age/ (do´saj) the determination and regulation of the size, frequency, and number of doses. dos·age n. 1. Administration of a therapeutic agent in prescribed amounts. amount) across the range of BEMA(TM) Fentanyl doses tested. This result is known as dose proportionality, meaning that a change in the dose results in a proportional change in the maximum circulating concentration of the subject pharmaceutical. Achieving dose proportionality is a key milestone in the clinical testing of a pharmaceutical product. This study was performed in healthy subjects (not patients) to evaluate the relationship between the dose of fentanyl administered and the plasma concentrations achieved. Plasma fentanyl concentrations are related to the pharmacologic pharmacologic /phar·ma·co·log·ic/ (-kah-loj´ik) pertaining to pharmacology or to the properties and reactions of drugs. pharmacological, pharmacologic pertaining to pharmacology. effects of the product and normal volunteers are typically used for these studies. Participating subjects received each of 3 different doses of BEMA(TM) Fentanyl. Dr. Andrew Finn, BDSI's Executive Vice President of Clinical Development and Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Dr. Mark Sirgo, BDSI's President and Chief Executive Officer, added "While this study was a necessary component of our BEMA(TM) Fentanyl development program for the treatment of breakthrough cancer pain, we believe that the results serve as an important demonstration of the robustness of our patented BEMA(TM) delivery system and its ability to accommodate several different strengths of fentanyl in a dose proportionate fashion. These same dosage strengths are part of our BEMA(TM) Fentanyl Phase III Noun 1. phase III - 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 FDA program, which we anticipate completing by the end of 2006. These study results add to the body of evidence we are collecting on BEMA(TM) Fentanyl that support our confidence in the commercial viability of this product in the marketplace." Within the global market, pain medication generates estimated annual sales of more than $24 billion. An estimated $2 to $4 billion is targeted at breakthrough pain, with BEMA(TM) Fentanyl's indication of breakthrough cancer pain being a subset of this market. BDSI believes that BEMA(TM) Fentanyl maintains a strong potential of securing a significant share of the breakthrough cancer pain market in the U.S. The company estimates that BEMA(TM) Fentanyl will generate minimum annual peak sales of $250 million. About BioDelivery Sciences International BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. targeted at "acute" treatment opportunities such as pain, anxiety, 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. , and infections. The company's drug delivery technologies include: (i) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology and (ii) the patented Bioral(R) nanocochleate technology, designed for a potentially broad base of applications. The company's headquarters are located in Morrisville, North Carolina Morrisville is a town in Wake County, North Carolina, USA. The population was 5,208 at the 2000 census. A Special Census was conducted by the United States Census Bureau in March 2004, when the population was enumerated at 11,915. and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, 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, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the results of scheduled or additional clinical trials and 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. review of the Company's formulations and products, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). Peak sales estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all. |
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