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news.Endo Pharmaceuticals has reported results from a further phase III clinical trial of the safety and efficacy of its drug oxymorphone ER for the treatment of moderate-to-severe chronic low back pain.
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The study was conducted in order to address concerns raised by the FDA regarding the safety and efficacy of the drug. In a written response to the company’s initial new drug application for the product, the agency requested that the company carry out an additional clinical trial, before it would grant its approval for the commercialization of the drug.
According to the company, results of this supplemental study demonstrated statistically significant difference in pain scores between oxymorphone ER and placebo during a 12-week treatment period, during which the drug was administered twice daily.
“We are very pleased with the outcome of this trial, which further supports the potential clinical utility of oxymorphone ER in treating chronic, moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time,” said Peter Lankau, president and CEO. “We are now preparing to submit our complete response to the FDA’s approvable letter and expect it to be submitted by early 2006.”
The company now expects to receive an official response from the FDA within six months of the filing of the complete new drug application for oxymorphone ER.