SOLESTA pivotal study meets primary endpoints for fecal incontinence treatment

Dec 8 2009

Q-Med AB and Oceana Therapeutics, Inc. today announced that the SOLESTA(TM) pivotal study succeeded in meeting both primary endpoints for the treatment of fecal incontinence.

Q-Med AB and Oceana Therapeutics, Inc. intend to submit a PMA application to the FDA during the first quarter of 2010 based on the results of this study.

"This study is the ultimate result of years of hard work as we developed a product using our minimally invasive technology," said Bengt Agerup, Q-Med's President and CEO, and inventor of the NASHA(TM) technology. "It is with great pride that together with our partner, Oceana Therapeutics, we can move forward with the FDA approval process and work towards bringing SOLESTA(TM) into clinical practice."

Fecal incontinence is a significant problem for many adults as it relates to the loss of voluntary control of stool, or bowel movements. It affects about 2 percent of the general population. Both men and women suffer from this problem, though it is more common in women because of injury during childbirth. The condition can have devastating effects on a patient's quality of life and psychological well being as many people resort to altering their social and physical activities, even their employment, to cope with the problem.

"We are extremely encouraged by the positive results from this pivotal trial. We believe SOLESTA has the potential to make a significant contribution in fulfilling an unmet medical need in the management of fecal incontinence and will therefore be a great addition to Oceana's product portfolio," said John Spitznagel, Chairman and CEO, Oceana Therapeutics, Inc. "These findings also mark an important milestone for the partnership between Q-Med AB and Oceana as the study outcomes will allow us to file for approval with the FDA in the first quarter of 2010."

Oceana's President and COO, David S. Tierney, M.D. added, "While SOLESTA is already available in Europe, we are confident that the publication of the study will enhance the adoption of this important treatment among the European professional community to help patients suffering from this condition."