King Pharmaceuticals, Inc announced additional information regarding the resubmission plan for the Remoxy New Drug Application (NDA). The company is not required by the Food and Drug Administration (FDA) to conduct clinical trials in order to provide additional safety or efficacy data in patients with moderate to severe chronic pain. However, as part of the resubmission plan, and in order to strengthen the NDA, King plans to conduct a likeability study and a pharmacokinetic trial in volunteers. The Company continues to anticipate the resubmission could occur mid-year 2010.
Remoxy, an investigational drug, is a unique, long-acting oxycodone formulation for moderate-to-severe chronic pain designed to reduce potential risks of unintended use.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products that complement the Company's focus in specialty-driven markets, particularly neuroscience, hospital care.