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Abstract on Columbia Laboratories' Lidocaine Vaginal Gel Published in ACOG's Obstetrics & Gynegology

Posted on: Monday, 4 April 2005, 15:00 CDT

Columbia Laboratories, Inc. (NASDAQ:CBRX) announced that an abstract highlighting positive outcomes of a 24-patient, single-blind, parallel-group, placebo-controlled study of lidocaine vaginal gel, the Company's investigational dysmenorrhea treatment, was published in the April 2005 supplement to Obstetrics & Gynecology, the Journal of the American College of Obstetricians and Gynecologists (ACOG).

Study authors Dominique DeZiegler, M.D., University of Geneva, Geneva, Switzerland, et al, concluded that pretreatment 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 (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.

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 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 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 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 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.

Source: Business Wire

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