New drug seeking approval from the FDA effective in relieving chronic pain
A new drug seeking approval from the FDA, ALO-01 (Embeda), has been proven effective in relieving chronic pain. According to findings from research revealed at the annual clinical meeting of the American Academy of Pain Management, 72.5% of patients responded to the morphine drug with a built in anti-abuse factor, compared to 57.8% of those taking placebo. The researchers defined response as more than 30% improvement in pain intensity score from baseline. The research team reported that the drug was accepted for a priority review from the FDA on Sept. 2. According to Joseph Stauffer, D.O., of Alpharma Pharmaceuticals, if the drug is approved it would be “… the first opioid medicine to provide a pharmacologic abuse-deterrent feature while effectively treating patients with chronic pain.” The following is an excerpt of an article from Medpage Today that reviews findings about the new drug:
To avoid that possibility, Dr. Stauffer said, ALO-01 capsules contain polymer-coated extended-release pellets of morphine sulfate and each has a core of naltrexone (Depade, ReVia), an opioid antagonist.
The idea is that the naltrexone will kick in and reduce the euphoric effects of morphine if the capsule is crushed or chewed. Otherwise, the naltrexone is intended to pass through the body without “clinically meaningful release or accumulation,” according to a company statement.
In the current study, the researchers enrolled 344 adult patients with moderate to severe pain from osteoarthritis of the hip or knee. After up to 14 days of screening and washout, they were titrated to effective pain management levels with ALO-01 in an open-label fashion.
Volunteers were then randomized in a double-blind fashion to either ALO-01 capsules or placebo for 12 weeks.
The main endpoint was mean change in weekly average pain diary score from randomization to the 12-week visit. Responder rate was a secondary efficacy endpoint.
The researchers analyzed the usual adverse events, but also evaluated the possibility of opioid withdrawal using the Clinical Opiate Withdrawal Scale — a clinician assessment of objective signs of withdrawal — and the Subjective Opiate Withdrawal Scale, a self-administered instrument.