PHILADELPHIA--(EON: Enhanced Online News)--iCeutica, a company creating branded medicines that provide meaningful clinical benefits to patients and providers, today announced positive top-line results from its Phase 1 trial of ICE 1201, a submicron version of metaxalone, a muscle relaxant indicated for the treatment of acute, painful musculoskeletal conditions. Trial results demonstrated improved oral bioavailability, decreased pharmacokinetic variability, more rapid absorption and decreased food effect, when compared to the currently marketed metaxalone product, SKELAXIN®. Both ICE 1201 and SKELAXIN® were well tolerated, with only mild adverse events reported.
“The lower dose may potentially reduce side effects such as somnolence, which may better enable daytime dosing and may also expand the use in older adults.”
“These results demonstrate that ICE 1201 has the potential to provide a faster onset-of-action and pain relief at lower doses, both benefits that are important to patients suffering from acute painful musculoskeletal conditions,” said Dr. Paul Nemeth, Vice President of Clinical Development and Regulatory Affairs of iCeutica. “The lower dose may potentially reduce side effects such as somnolence, which may better enable daytime dosing and may also expand the use in older adults.”
Matthew Callahan, President and CEO of iCeutica, added: “We believe that ICE 1201 represents a significant commercial opportunity, as it has the potential to better address and even grow the approximately $400 million metaxalone market in the United States. iCeutica is actively seeking a partner for this program to advance into Phase 3 development and tap into the existing U.S. market and potentially Europe, where metaxalone has not been previously approved, as well as other international markets.”
The Phase 1 trial enrolled 20 healthy volunteers. Utilizing a four-way crossover design, the study evaluated patients’ response to a 300mg dose of ICE 1201, a 600mg dose of ICE 1201, an 800mg dose of SKELAXIN®, and a 600mg dose of ICE 1201 following a fatty meal.
Matthew Callahan will be presenting details of this program and the company’s other branded programs at the 2013 BioPharm America Conference (#BPA13) in Boston on September 18th, 2013 at 11:45 AM.
iCeutica creates branded medicines by combining our proprietary SoluMatrix™ technology with deep scientific expertise and commercial insights. Our pipeline products provide meaningful clinical benefits for patients and have clearly defined pathways to regulatory and commercial success. We rapidly drive products to market with pharmaceutical partners and by creating new opportunities in focused therapeutic areas. www.iceutica.com
SKELAXIN® is a registered trademark of King Pharmaceuticals.