Angiotech: Data shows Adhibit reduces surgical adhesions in patients after myomectomy

By E. Janene Geiss

Philadelphia, April 7 - Angiotech Pharmaceuticals, Inc. announced Friday positive results from its Adhibit adhesion prevention gel myomectomy study that showed a reduction in post-operative adhesion formation.

The randomized, controlled, single-blind, clinical study was designed to evaluate the safety and efficacy of Adhibit in reducing the incidence and severity of post-operative adhesions when applied immediately after the removal of uterine fibroids, called myomectomy surgery, according to a company news release.

The study was conducted at six investigational sites in Europe, Canada and the Netherlands.

The trial randomized 71 patients with 48 patients receiving the Adhibit treatment and 23 patients receiving no post-operative adhesion treatment. Patients were surgically re-examined eight to 10 weeks post-procedure to determine the incidence and severity of adhesions, officials said.

Adhibit was shown to reduce post-operative adhesion formation as measured by the modified American Fertility Society score, a scoring system that factors in both the extent and tenacity of adhesions.

Patients in the group that were treated with Adhibit experienced a statistically significant reduction in their score when compared with those in the control group, officials said.

"Consistent with preliminary results, we're encouraged and pleased that this data indicates Adhibit is safe and effective," Rui Avelar, chief medical officer for Angiotech, said in the release. "Adhibit also proved itself to be easily delivered through a laparoscope, and has the potential to further advance minimally invasive surgery in women."

The final data set was presented Friday at the 19th Annual European Congress of Obstetrics and Gynecology in Torino, Italy.

Adhibit is a fully synthetic, sprayable hydrogel that is safely resorbed by the body over 30 days and is designed to reduce or prevent the formation of post-operative surgical adhesions.

Currently approved in Europe to prevent or reduce post-surgical adhesion formation in pediatric patients undergoing cardiac surgery, Adhibit is an Angiotech product that is sold and marketed by Baxter Healthcare Corp. worldwide, excluding the United States. Baxter has an option to license Adhibit in the United States, but the product is not currently approved for sale in the country.

Angiotech is a Vancouver, B.C., specialty pharmaceutical company that develops innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury or trauma.

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