Abstract on Columbia Laboratories' Lidocaine Vaginal Gel Published in ACOG's Obstetrics & Gynegology.LIVINGSTON, N.J. -- Columbia Laboratories, 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 :CBRX) announced that an abstract highlighting positive outcomes of a 24-patient, single-blind, parallel-group, placebo-controlled study of lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a vaginal gel, the Company's investigational dysmenorrhea dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. treatment, was published in the April 2005 supplement to Obstetrics & Gynecology, the Journal of the American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S. (ACOG ACOG American College of Obstetricians and Gynecologists. ACOG American College of Obstetricians & Gynecologists ). Study authors Dominique DeZiegler, M.D., University of Geneva The University of Geneva (Université de Genève) is a university in Geneva, Switzerland. It was founded by John Calvin in 1559. Initially a theological seminary, it also taught law. , Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland, et al, concluded that pretreatment pretreatment, n the protocols required before beginning therapy, usually of a diagnostic nature; before treatment. pretreatment estimate, n See predetermination. with lidocaine vaginal gel reduces intrauterine pressure, uterine contraction frequency and pain of induced dysmenorrhea, suggesting a new treatment option. Columbia is currently completing a dose-ranging study to assess the pharmacokinetics of this product, and plans to initiate a Phase II study in the second quarter of 2005 to further evaluate lidocaine vaginal gel in the treatment of dysmenorrhea. This study was designed to evaluate lidocaine formulated with Columbia's proprietary bioadhesive vaginal gel versus placebo. Cramping episodes were triggered in the 24 dysmenorrheic women with an intravenous vasopressin vasopressin (văz'ōprĕs`ĭn): see antidiuretic hormone. (VP) infusion. Intrauterine pressure was measured and pain assessed every 15 minutes for 60 minutes. In order for a patient to continue in the study, intrauterine pressure increments after the first VP infusion had to be greater that 40% and return to within 15% of baseline within 60 minutes. Nineteen patients met these criteria and subsequently received 5% lidocaine vaginal gel (n=10) or placebo (n=9). After resting four to five hours, these patients received a second VP infusion and were again measured for intrauterine pressure and pain. Results were expressed as differences between the first and second VP infusions. All measures were reduced in women treated with lidocaine vaginal gel compared to placebo. The abstract, entitled Pretreating with Vaginal Lidocaine Reduces Induced Uterine Contractions and Pain in Chronic Dysmenorrhea, will be presented as a poster at the ACOG 2005 Annual Clinical Meeting, to be held May 7-11, 2005, in San Francisco, California “San Francisco” redirects here. For other uses, see San Francisco (disambiguation). The City and County of San Francisco (EN IPA: [sænfrənˈsɪskoʊ] . About Dysmenorrhea Dysmenorrhea is characterized by recurrent uterine cramping and pain during, and sometimes just before, a woman's monthly period. Symptoms usually last two to three days. This condition affects nearly one in six women worldwide, and is the leading cause of workplace and school absences. About Columbia Laboratories Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's health care and endocrinology products. Columbia markets Prochieve(R) 8% (progesterone gel) for progesterone supplementation as part of an Assisted Reproductive Technology Assisted reproductive technology (ART) is a general term referring to methods used to achieve pregnancy by artificial or partially artificial means. It is reproductive technology used in infertility treatment, which is the only application routinely used today of treatment for infertile women with progesterone deficiency and Prochieve(R) 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets Striant(R) (testosterone buccal system) for the treatment of hypogonadism Hypogonadism Definition Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate. in men. Columbia's products and product candidates utilize the company's bioadhesive drug delivery technology, which is able to deliver a broad range of compounds, including peptides, across many of the body's mucosal surfaces to address numerous therapeutic areas. The Company is investigating the potential utility of Prochieve 8% in the prevention of preterm birth and developing a vaginally-administered lidocaine product to treat dysmenorrhea and pelvic pain. For more information, please visit www.columbialabs.com. Safe Harbor Statement Under 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: Except for historical information contained herein, certain statements of Columbia Laboratories, Inc.'s expectations made in this press release, including those regarding the Company's clinical research programs, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Those statements include statements regarding the intent, belief or current expectations of Columbia Laboratories and its management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, the following: the timely and successful development of formulations of lidocaine vaginal gel, positive results from subsequent lidocaine vaginal gel trials, timely and successful completion of clinical studies, the timely and successful development of products; success in obtaining acceptance and approval of new products and indications for current products by the 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. and international regulatory agencies; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and health care industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements. Striant(R) and Prochieve(R) are registered trademarks of Columbia Laboratories, Inc. |
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