Preclinical Results Show Alliqua's Investigational Lidocaine Transdermal Patch Compares Favorably to Lidoderm Patch
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.
Legal Notice Regarding Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, inadequate capital, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, termination of contracts or agreements, technological obsolescence of our products, technical problems with our research and products, price increases for supplies and components, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists and other specific risks. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The 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. There can be no assurance that further research and development, and/or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that we will be able to develop new products on the basis of our technologies. In addition, other factors that could cause actual results to differ materially are discussed in our Annual Report on Form 10-K/A filed with the SEC on May 16, 2013, and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.
Brian M. Posner
Chief Financial Officer
Dian Griesel Int'l.
SOURCE Alliqua, Inc.
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