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Extended-Release Oxycodone/Acetaminophen Combo Shows Promise in Phase III Trial

Pain significantly reduced versus placebo (September 5)

The investigational drug MNK-795 (Mallinckrodt) has achieved the primary endpoint in a phase III efficacy study in the treatment of acute pain following a bunionectomy. In the study, the drug showed statistically significant improvement in pain scores compared with placebo from baseline over 48 hours.

The new data will be presented at PAINWeek, a national conference on pain for frontline practitioners, which is being held September 4–7 in Las Vegas, Nevada.

MNK-795 is an investigational, extended-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The tablet was designed with immediate and extended-release components and potentially tamper-resistant properties. In July, the FDA accepted for filing the New Drug Application (NDA) for MNK-795 and granted priority review.

The randomized, double-blind, placebo-controlled, phase III study compared MNK-795 with placebo in 329 patients with moderate-to-severe acute pain following a unilateral first metatarsal bunionectomy. The subjects received either a fixed dose of two MNK-795 tablets (7.5 mg oxycodone hydrochloride and 325 mg acetaminophen per tablet) every 12 hours over 48 hours, or two placebo tablets. Supplemental ibuprofen (up to 400 mg every 4 hours) was allowed for both the MNK-795 and placebo arms.

The primary endpoint was the summed pain intensity difference (the change in pain from baseline) over 48 hours (SPID48).

The combination of oxycodone and acetaminophen, already available as generics, is highly addictive and is often abused by snorting or by injecting into the muscles or veins. Percocet (Endo Pharmaceuticals) and Tylox (Johnson & Johnson) are branded versions.

Sources: Mallinckrodt; September 5, 2013; and Reuters; September 5, 2013.

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