Niaspan is the only FDA-approved once-daily prescription niacin formulation for the treatment of lipid disorders with the ability to elevate HDL, or ‘good,’ cholesterol by up to 26%. It is also indicated for the secondary prevention of heart attacks, and, in combination with a bile-acid binding resin, to promote regression of coronary atherosclerosis in patients with high cholesterol.
The new range of Niaspan caplet formulation (CF) products includes an optimized 1000mg formulation of Niaspan (niacin once-daily, extended-release tablets).
A recent clinical study demonstrated a significantly improved overall flushing profile of optimized Niaspan CF versus commercialized Niaspan, with a 42% reduction in flushing severity and 43% reduction in the duration of flush. Notably, the significant reductions in flushing severity and duration were achieved in the absence of aspirin or other non-steroidal anti-inflammatory drug (NSAID) co-administration.
“This complete dosage range of Niaspan CF products draws upon the proven efficacy and safety of Niaspan, and could further enhance patient acceptance and compliance in addition to improving tablet aesthetics and mechanical strength,” said Adrian Adams, president and CEO of Kos.
Kos has begun planning for a first quarter 2007 launch for Niaspan CF. Furthermore, based on the demonstrated benefits of the optimized Niaspan CF product, Kos is planning to develop other optimized products as part of a fully integrated development program in HDL raising.