Embeda Shows Pain Relief in Results
Of Phase III Trial, Alpharma Says
I would have expected a drug containing morphine to do a little better against placebo - Doc
By KATHY SHWIFF
September 9, 2008 4:21 p.m.
Alpharma Inc. said Phase III trial results showed its Embeda pain drug provided significant relief in patients with moderate to severe pain from osteoarthritis of the hip or knee compared with placebos.
The findings also showed that the capsules were safe and well-tolerated by patients. The study was presented at the 19th annual clinical meeting of the American Academy of Pain Management in Nashville.
The specialty-pharmaceutical company is developing Embeda for treatment of moderate to severe chronic pain. Using the company's proprietary technology, the capsules combine an extended-release opioid, morphine sulfate, with a sequestered core of naltrexone, an opioid antagonist. When the abuse-resistant pain treatment is taken as directed, the naltrexone passes through the body without clinically meaningful release or accumulation.
The study found that patients taking Embeda reported significantly more effective pain relief, as measured by a change in a weekly pain intensity score, compared with patients taking placebos. According to the results, 73% of patients taking Embeda reported at least 30% pain relief from the baseline score, compared with 58% of those taking placebos reporting similar relief.
"These results are very exciting as we believe they demonstrate that ALO-01 (Embeda) has the potential to bring clear clinical benefit to pain patients while delivering peace of mind to physicians and pharmacists," said Alpharma Chief Medical Officer Joseph Stauffer.
The company said last week that the Food and Drug Administration granted Embeda capsules priority review, which is expected to be done within six months from the date of submission. The application was submitted June 30.
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