CIMA LABS Announces IND Filing and Commencement of Clinical Trials On OraVescent(R) Fentanyl for Treating Breakthrough Cancer Pain.Business Editors & Health/Medical Writers EDEN PRAIRIE Eden Prairie A city of eastern Minnesota, a residential suburb of Minneapolis. Population: 57,300. , Minn.--(BUSINESS WIRE)--Sept. 3, 2002 CIMA LABS INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq:CIMA) today announced the commencement of clinical trials on its proprietary OraVescent(R) 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 product, following the Food and Drug Administration's (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. ) receipt of CIMA's Investigational New Drug (IND) submission at the end of July. OraVescent is a proprietary, oral drug delivery technology that improves the absorption of active drug ingredients across mucosal membranes lining the mouth. CIMA's product incorporates its enabling OraVescent technology with fentanyl, an active drug ingredient used for treating breakthrough cancer pain. Preliminary human pharmacokinetic studies conducted by CIMA have found that OraVescent fentanyl was absorbed significantly more quickly and to a greater extent than Actiq, a commercially-available oral transmucosal medication based on fentanyl. The pharmacokinetic clinical studies now underway are designed to compare OraVescent fentanyl and Actiq at different 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. levels. These studies are part of CIMA's plan to develop and submit to the FDA 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 ), which CIMA believes could be approved by late 2004. John M. Siebert, Ph.D., president and chief executive officer, commented: "OraVescent is a key component of our proprietary product strategy. This strategy should enable us to retain a greater proportion of the economic value of the products we successfully develop in comparison to those developed through partner-funded collaborations. CIMA has the financial and technical resources to develop an OraVescent product for breakthrough cancer pain. We intend to complete clinical trials and initiate a regulatory submission before we seek out a marketing partner for OraVescent fentanyl." About CIMA LABS CIMA develops and manufactures prescription and over-the-counter products based upon its proprietary, fast-dissolve drug delivery technologies, OraSolv(R) and DuraSolv(R). Based on our technologies, an active drug ingredient, which we frequently taste-mask, is formulated into a new, orally disintegrating dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. that dissolves quickly in the mouth without chewing chewing or mastication Up-and-down and side-to-side movements of the lower jaw, using the teeth to grind food for easier swallowing. During chewing, the tongue shapes food into a lump and saliva lubricates it for swallowing. or the need for water. CIMA's business involves a dual operating strategy. We develop and manufacture fast-dissolve versions of drugs for pharmaceutical company partners for whom we currently produce three branded prescription pharmaceuticals and two over-the-counter brands. CIMA is also developing proprietary products utilizing our fast-dissolve technologies, as well as our new OraVescent(R) enhanced absorption, transmucosal drug delivery system. This press release, including the information related to CIMA's expectations about new product developments and introductions, contains 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. 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. A number of factors could cause actual results to differ materially from CIMA's assumptions and expectations. These factors include the outcomes of human clinical trials and the rulings of the FDA. Additional factors that may cause actual results to differ from CIMA's assumptions and expectations include those set forth under the heading "Factors That Could Affect Future Results" included in CIMA's most recent filings with the Securities and Exchange Commission. All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements. |
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