Echo Therapeutics closes trial, preps for FDA submission in the "near future"

August 24, 2010 by MassDevice staff

Echo Therapeutics Inc. completes a clinical trial of its Prelude SkinPrep transdermal drug delivery system, saying it will seek 510(k) clearance from the Food & Drug Administration in the "near future."

ECTE logo

Echo Therapeutics Inc. (OTC:ECTE) announced the completion of a clinical trial of its Prelude SkinPrep transdermal drug delivery system, saying an application for 510(k) clearance from the Food & Drug Administration is imminent.

The Franklin, Mass.-based company launched the trial in April, in partnership with Ferndale Pharma Group Inc., to test the drug-device combination with Ferndale's 4 percent topical lidocaine. The needle-free system ablates a thin layer of skin before a drug is applied.

The trial was designed to "evaluate the ability of the Prelude SkinPrep System to ablate the skin prior to application of OTC 4 percent lidocaine cream for local dermal anesthesia." Echo said the blind comparison study "demonstrated remarkable improvement and an abbreviated onset of action" when its device was used in conjunction with the lidocaine preparation. The pharma firm has a license to develop and sell the Prelude for its 4 percent lidocaine product in North America and the U.K., according to a press release.

Echo posted strong second-quarter results for the three months ended June 30, dramatically increasing its top-line while slashing net losses. Second-quarter net losses were $536,000, or 2 cents per share, on sales of $264,000. That compares with net losses of $6.8 million, or 46 cents per share, on sales of $121,000 during the same period last year.

ECTE shares were trading at $1.15, up nearly 1 percent, in early-morning activity.

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