Phase III Data from Mallinckrodt


Mallinckrodt (MNK) recently presented positive data on its pain candidate, MNK-795, from a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose phase III study.

Mallinckrodt said that a statistically significant improvement in pain scores was achieved by MNK-795 compared to placebo from baseline over 48 hours. The study was conducted in patients with acute pain following a unilateral first metatarsal bunionectomy.

This study is a part of the 505 (b)(2) application submitted by Mallinckrodt to the FDA for MNK-795. The 505 (b)(2) regulatory pathway allows a company to depend partly on data from existing reference drugs.

MNK-795, an extended-release oral formulation of oxycodone and acetaminophen, is currently under FDA review. The candidate has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is suitable.

The phase III data was presented in the first week of September at PAINWeek, a national conference on pain for frontline practitioners.

Mallinckrodt also presented data from a human abuse liability (HAL) study which was conducted to compare certain abuse-related characteristics of MNK-795 with those of Percocet, an immediate-release formulation of oxycodone/acetaminophen.

Results showed that measures of drug liking, drug high and good drug effects in intact and crushed MNK-795 were lower compared to Percocet when measured at the peak drug effect. The results were statistically significant.

With the FDA granting priority review status to MNK-795, a final response regarding its approval should be out later this year.

Mallinckrodt currently carries a Zacks Rank #4 (Sell). At present, companies like Supernus Pharmaceuticals, Inc. (SUPN), Actelion Ltd. (ALIOF) and Actavis, Inc. (ACT) look well-positioned. While Supernus and Actelion are Zacks Rank #1 (Strong Buy) stocks, Actavis is a Zacks Rank #2 (Buy) stock.

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