MNK-795 showed a statistically significant improvement in pain scores compared to placebo
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 using technology with immediate and
extended-release components and potentially tamper-resistant properties.
In July, the
“Mallinckrodt is dedicated to developing and providing safe and
effective medications for the treatment of patients with pain, and we
believe these data represent an important milestone toward this
commitment,” said
The Phase 3 study was part of a 505 (b)(2) application, which is a
regulatory pathway relying, in part, on data from existing reference
drugs.
Study Details
The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose clinical trial comparing MNK-795 with placebo in 329 patients with acute pain following a unilateral first metatarsal bunionectomy. Subjects received either a fixed-dose of study medication (MNK-795, 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen tablets) of 2 tablets every 12 hours over 48 hours, or placebo. Supplemental ibuprofen up to 400 mg every 4 hours was allowed for both the MNK-795 and placebo arms. Pain intensity was recorded at 2, 4, 8, and 12 hours after each dose, with additional recordings at 15, 30, 45, 60, and 90 minutes after the first dose.
The study evaluated the efficacy and safety of MNK-795 in patients with moderate to severe acute pain. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48). The most common adverse events associated with the use of MNK-795 were nausea, dizziness, headache, vomiting, constipation, and somnolence (sleepiness).
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