Alpharma Inc, a global specialty pharmaceutical company, announced results from its phase-III pivotal efficacy trial that showed ALO-01 (EMBEDAä) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) capsules provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared to placebo. Findings also showed that ALO-01 capsules were safe and well-tolerated. This study was presented in a poster session at the 19th Annual Clinical Meeting of the American Academy of Pain Management in Nashville.
ALO-01 is an investigational pharmacologic abuse-deterrent, extended-release opioid that Alpharma is developing for the treatment of moderate to severe chronic pain. Utilizing Alpharma's proprietary technology, ALO-01 capsules combine an extended-release opioid, morphine sulfate, with a sequestered core of naltrexone, an opioid antagonist. When ALO-01 capsules are taken as directed, the naltrexone passes through the body without clinically meaningful release or accumulation.
According to the study findings, patients who were taking ALO-01 capsules reported significantly more effective pain relief, as measured by mean change in the weekly Brief Pain Inventory (BPI) Average Pain Intensity Score from baseline to the 12-week endpoint of the study, compared to patients who were taking placebo. Additionally, 72.5 per cent of patients reported taking ALO-01 experienced pain relief of at least 30 per cent from baseline, compared to 57.8 per cent patients given placebo.
"These results are very exciting as we believe they demonstrate that ALO-01 has the potential to bring clear clinical benefit to pain patients while delivering peace of mind to physicians and pharmacists," said Joseph Stauffer, chief medical officer, senior vice president of Clinical Research & Medical Affairs, Alpharma Pharmaceuticals. "We look forward to collaborating with the FDA during the review process for ALO-01, which, if approved, would be the first opioid medicine to provide a pharmacologic abuse-deterrent feature while effectively treating patients with chronic pain."
On September 2nd, Alpharma announced that the United States Food and Drug Administration (FDA) had accepted its New Drug Application (NDA) for ALO-01 capsules for priority review. The priority review status provides for a review period of six months from the date of submission. The ALO-01 capsule NDA was submitted on June 30, 2008.
In the United States, pain is a serious undertreated public health problem, with 19 per cent of American adults reporting chronic pain and 34 per cent reporting recurrent pain.
Alpharma is a global specialty pharmaceutical company with leadership positions in products for humans and animals.