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Uluru Files 510(k) Application With FDA To Expand Label Claim Of Altrazeal

Specialty pharmaceutical company Uluru Inc. (ULU) Wednesday announced the filing of an abbreviated 510(k) application with the U.S. Food and Drug Administration to expand its wound dressing powder Altrazeal's label claim to include the management and mitigation of pain.

The Addison, Texas-based wound care products maker said the filing of the 510(k) application is part of its ongoing strategy of product line extension. A randomized clinical study comparing Altrazeal to Acquacel Ag in skin graft donor sites was the main data supporting the 510(k) application.

The amended label claim was also supported by Altrazeal's clinical experience in various wound types including venous leg ulcers, second degree burns, geriatric wounds and numerous less common wound types, Uluru noted.

In the randomized clinical study, Altrazeal demonstrated a statistically significant reduction in pain in patients at all 3 time points evaluated. Patients also reported a statistically significant improvement in comfort.

Further, Altrazeal showed a significant reduction in pain when used to treat venous leg ulcers. Wound pain is a significant issue for venous leg ulcer patients, causing poor patient compliance, fatigue, sleep disturbances and depression.

All patients, who had experienced venous leg ulcers for 3 to 27 years, reported improvement in pain levels within 15 minutes of the application of Altrazeal. They also reduced oral pain medication, Uluru said.

In addition, a group of second degree burn patients reported a dramatic drop in pain upon application of Altrazeal to their wounds.

Commenting on the 510(k) application, Kerry Gray, President and CEO of ULURU Inc., stated, "Achieving this amended label claim will be a significant competitive advantage and further differentiate Altrazeal® from other wound products."

Uluru also stated that it plans to file additional 510(k) applications and product line extensions in the near term. The company also intends to initiate an additional randomized clinical study to prove healing benefits associated with Altrazeal.

ULU is trading at $0.0670, up $0.0029 or 4.52 percent, on a volume of 521,022 shares.

by RTTNews Staff Writer

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