The drug is produced in such a way that makes it more difficult to crush the pill to extract its contents to snort or inject, according to a news release by the company.
In the clinical safety and efficacy trial, approximately half (48 percent) of patients reported at least 50 percent improvement in pain intensity. The most common side effects included constipation, nausea, dizziness and headaches, which are common with opioid painkillers, according to the release.
The company has also conducted laboratory manipulation and extraction studies, pharmacokinetic studies and clinical abuse potential studies.
“We are very encouraged by the results of this pivotal study,” said Gary Stiles, MD, senior vice president of research and development at Purdue Pharma, in the news release. “This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers.”
Purdue Pharma plans to file a New Drug Application with the U.S. Food and Drug Administration for this drug later in the year, according to the news release.
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