NOTTINGHAM, UK, and DEERFIELD, Ill., Aug. 1 /PRNewswire-FirstCall/ -- Innovata plc and Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved ADEPT(R) Adhesion Reduction Solution for use in gynecological laparoscopic procedures in the United States.
ADEPT is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis. ADEPT is a 4% icodextrin solution that has been used for adhesion reduction in Europe since 2000.
ADEPT has been studied in three randomized, controlled U.S. clinical trials involving a total of 548 patients undergoing gynecological laparoscopic surgery with a follow-up (second look) laparoscopic procedure after the initial procedure. In the pivotal study, for the patients in the ADEPT group, 45.4% were defined as a “clinical success” compared to 35.6% in the control group. Clinical success was defined as a decrease in the number of adhesions between the first (baseline) and second laparoscopies. Patients in the ADEPT group had significantly (p=0.016) fewer sites with adhesions at second-look compared to first-look adhesiolysis laparoscopy.
Adhesions are abnormal attachments between tissues or organs. Gynecological adhesions may cause pain, secondary infertility or other complications in women.
“This is a significant development for patients with adhesion-related disorders and the surgeons who are managing those patients,” said Thomas Lyons, MD, of Atlanta, GA, who served as one of the clinical investigators for the U.S. trials. “This is currently the only product which has approval for laparoscopic use, making it doubly helpful since laparoscopic surgery is a better solution for adhesions than traditional open surgery. As a gynecologic surgeon who works in this area I am excited for our patients and look forward to improved outcomes for our patients.”
ADEPT is the first and only approved fluid-based approach for adhesion reduction in gynecological laparoscopic adhesiolysis in the United States. ADEPT is a liquid, which means it can be delivered directly and rapidly to the site through a laparoscopic port during surgery.
Developed by Innovata, ADEPT is licensed to Baxter on a global basis. Baxter’s BioSurgery business will launch ADEPT in the United States in the fourth quarter. Baxter’s BioSurgery business develops and commercializes biosurgery products used in the areas of hemostasis, tissue sealing and tissue repair.
“ADEPT is one of the most important gynecological surgical device developments in the last decade, filling a niche where there are limited options,” said Kieran Murphy, chief executive officer of Innovata. “The U.S. FDA approval will allow the product to be used by surgeons in the world’s largest market, significantly expanding its presence beyond Europe. We look forward to working with our partners at Baxter to prepare for the commercial launch.”
“Through its use on more than 150,000 patients in Europe and in U.S. clinical trials, ADEPT has demonstrated its convenience, and safety and efficacy in reducing the number of adhesions following surgery,” said Gordon Sutherland, general manager of BioSurgery for Baxter. “We believe the anti- adhesion market has been underserved, and are looking forward to providing physicians with an easy-to-use solution.”
ADEPT contains icodextrin derived from cornstarch and is contraindicated in patients with known or suspected allergy to icodextrin and similar polymers. ADEPT is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with frank abdomino-pelvic infection. There have been rare reports of sterile peritonitis following the use of icodextrin. Leakage of ADEPT from port sites may lead to wound healing complications; meticulous fascial closure is advised. There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia. In such cases, the risk/benefit profile should be assessed before use of ADEPT.
Innovata plc specializes in the development of pulmonary products for the treatment of respiratory disorders and other serious diseases. Using its proprietary dry powder inhaler and drug formulation technologies, the company has developed a pipeline of revenue-generating/marketed and clinical-stage products. In addition, the company has a portfolio of non-pulmonary products with growing revenues. Innovata has established development and marketing partnerships with a number of pharmaceutical companies including Baxter, Merck KGaA, UCB and Otsuka. For further information, please see http://www.innovataplc.com .
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. . Baxter assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals, and biotechnology to make a meaningful difference in patients’ lives. For more information about Baxter, please visit http://www.baxter.com .
This release includes forward-looking statements concerning the availability and use of ADEPT. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: completion of final steps in product development, including scaling up production, including satisfactory quality and regulatory work; commercial acceptance of the product; and other risks identified in the company’s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company’s web site. The company does not undertake to update its forward-looking statements.
ADEPT(R) is a registered trademark of Innovata plc.
Baxter Healthcare Corporation
CONTACT: Media, Deborah Spak, +1-847-948-2349, or Investors, Mary KayLadone, +1-847-948-3371, both of Baxter; or Sarah MacLeod of FinancialDynamics for Innovata, 44 0 20 7831 3113, or Keiran Murphy, CEO of Innovata44 0 115 974 7474
