) recently presented positive data on its pain candidate,
MNK-795, from a multicenter, randomized, double-blind,
placebo-controlled, parallel-arm, multiple-dose phase III
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
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
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
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
Mallinckrodt currently carries a Zacks Rank #4 (Sell). At
present, companies like
Supernus Pharmaceuticals, Inc.
) look well-positioned. While Supernus and Actelion are Zacks
Rank #1 (Strong Buy) stocks, Actavis is a Zacks Rank #2 (Buy)
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