SALT LAKE CITY, March 30 /PRNewswire/ -- Lipocine Inc., a specialty bio-pharmaceutical company, today announced completion of a product definition study on LPCN 1029, their lead pain management product. LPCN 1029 is an improved formulation of a currently marketed drug that is limited in its clinical use to chronic pain indications due to slow absorption related to poor solubility. It is not indicated for the management of acute pain because fast onset is of paramount importance for any acute pain product.
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In a pharmacokinetic study in healthy volunteers comparing LPCN 1029 to the currently marketed product, the Lip’ral(R) (http://www.lipocine.com/home/content/view/38/210 ) based LPCN 1029 exhibited a greater than ten fold higher plasma drug concentration at the very first sampling time point of 20 minutes (p = 0.0013). The plasma concentrations for both systems were not statistically significantly different at the 24-hour time point.
“With the achievement of rapid and sustained blood levels that are known to be efficacious in acute pain, LPCN 1029 has the potential to become the first oral once-a-day, non COX-2 selective NSAID for acute pain management,” said Dr. Srinivasan Venkateshwaran, Chief Technology Officer and Vice President of R&D.
“Lipocine’s Lip’ral(R) (http://www.lipocine.com/home/content/view/38/210 ) technology is ideal for enabling rapid absorption of poorly water soluble drugs and its application to LPCN 1029 is highly likely to lead to faster pain relief,” Dr. Venkateshwaran added.
Acute pain market is projected to grow to at least $10 billion by 2010. Jerry Simmons, Corporate and Business Development Officer, said, “Physicians and patients prefer pain medications that are well tolerated, fast acting and administered once-a-day. LPCN 1029 qualifies on all counts.”
“With product definition complete, Lipocine is gearing up for efficacy studies to enable NDA filing in an expeditious manner. Due to recent market depletion of COX-2s, there is a significant unmet need for new and better options in acute pain management,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc.
Lipocine’s technology platforms, which can be applied to a wide range of products, include: Lip’ral(R): Clinically proven delivery technology for enhanced bioavailability of insoluble drugs. Lip’ral(R)-SSR (http://www.lipocine.com/home/content/view/39/211 ): Breakthrough oral controlled release technology for insoluble drugs. Hydroance(R) (http://www.lipocine.com/home/content/view/41/212 ): Novel oral delivery technology for water soluble, poorly permeable drugs especially macromolecules and vaccines.
Lipocine Inc. is a pharmaceutical company leveraging its proprietary drug delivery technologies to commercialize innovative pharmaceutical products. Lipocine business objectives are to develop products with established drugs that have patient friendly attributes such as faster absorption, lower dose, fewer side effects, less frequent dosing, no food effect. Lipocine has several products available for licensing in key therapeutic areas.
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CONTACT: Jerry Simmons of Lipocine Inc., +1-801-994-7383, ext. 2110,gts@lipocine.com
Web site: http://www.lipocine.com/
