Pharmacokinetic Study Encourages Additional Testing
LANGHORNE, Pennsylvania, October 16, 2013 /PRNewswire/ --
A preclinical study commissioned by Alliqua, Inc. (OTCQB: ALQA) ("Alliqua" or "the Company") concluded that the Company's investigational lidocaine transdermal patch compares favorably to the Lidoderm® (Lidocaine patch 5%) patch that is currently on the market. The overall study results indicate that Alliqua's patch is able to deliver in the pig a slightly higher amount of lidocaine than Lidoderm and to reach maximum delivery within a comparable period. No skin irritation occurred with either the Alliqua transdermal patch or Lidoderm patch. The study concludes that further development could result in Alliqua creating a commercial lidocaine patch that could be a generic version of the Lidoderm patch or provide better drug delivery resulting in a 505 (b)(2) approval.
David Johnson, Chief Executive Officer of Alliqua, said, "As we continue to expand our suite of wound care products, building the value proposition of our hydrogel technology for topical and transdermal drug delivery remains one of our major goals. The results of this preclinical study serve as a significant motivation for us to continue our efforts to develop a core transdermal delivery technology platform to deliver lidocaine and other beneficial ingredients through the skin."
James Sapirstein, Chief Executive Officer of Alliqua Biomedical, said, "The strong showing of our transdermal patch compared to Lidoderm, the leading product currently on the market, illustrates the potential of our technology. We are evaluating our strategic options to maximize these findings."
The primary objective of the study was to conduct a comparative pharmacokinetic (PK) analysis of lidocaine in Alliqua's transdermal patch compared to Lidoderm in the pig. The non-GLP in vivo crossover study was designed to evaluate the delivery of lidocaine over 24 hours in Alliqua's patch and Lidoderm with regard to feasible length of application.
The study found that Alliqua's patch offers a higher peak plasma concentration (Cmax) of lidocaine than Lidoderm (4.961.16 ng/mL versus 3.031.92 ng/mL) and higher mean total area under the curve (AUCtotal) than the competing product 66.5 ng/mL-h versus 48.9 ng/mL-h)). The mean period of peak concentration (Tmax) was 8.7 hours for Alliqua's patch versus 10.7 hours for Lidoderm.
In addition, Alliqua's patch was easier and cleaner to remove from the skin after application, with minimal or no patch impression (outline) remaining. The presence of adhesive in Lidoderm seemed to have a "peel-off effect" on the skin (similar to a band-aid); in contrast, Alliqua patch hydrogel has self-adhering characteristics and is easily removed from the skin at the end of a patch application without residual skin markings.
About Alliqua, Inc.
Alliqua, Inc. (ALQA) ("Alliqua") is a biopharmaceutical company focused on the development, manufacturing, and distribution of proprietary transdermal wound care and drug delivery technologies. Alliqua's technology platform produces hydrogels, a 3-dimensional cross-linked network of water soluble polymers capable of numerous chemical configurations.
Alliqua currently markets its line of 510(k) FDA-approved hydrogel products for wound care under the SilverSeal® brand, as well as the sorbion sachet S and sorbion sana wound care products. Alliqua's electron beam production process, located at its 16,000 square foot GMP manufacturing facility in Langhorne, PA, allows Alliqua to develop and custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. Additionally, Alliqua's drug delivery platform, in combination with certain active pharmaceutical ingredients, can provide pharmaceutical companies with a transdermal technology to enhance patient compliance and potentially extend the patent life of valuable drug franchises.
Any statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration.
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Brian M. Posner
Chief Financial Officer
Dian Griesel Int'l.
SOURCE Alliqua, Inc.