A first-in-class non-opioid analgesic has been given the green light by the FDA, the prescription suzetrigine (Journavx) 50mg oral tablet aimed at treating moderate to severe acute pain in adults.
The sodium channel blocker represents the first novel drug class approved to treat acute pain in more than 20 years, maker Vertex Pharmaceuticals told Medpage Today.
The medication is highly selective for NaV1.8, a voltage-gated sodium channel selectively expressed in peripheral pain-sensing neurons. Unlike opioids, suzetrigine blocks pain signals found only in the periphery, not in the brain, and is considered to be non-addictive.
The FDA’s decision was supported by two phase 3 trials – one of abdominoplasty patients, the other of people who had bunionectomy – that showed modest effectiveness. The trials randomised people with moderate to severe acute pain after surgery to either suzetrigine, hydrocodone bitartrate/acetaminophen, or placebo.
Both trials met the primary endpoint of time-weighted sum of pain intensity difference on the numeric pain rating scale at the 48-hour mark versus placebo. The least squares mean difference after abdominoplasty was 48.4 (P<0.0001); after bunionectomy, it was 29.3 (P=0.0002).
Suzetrigine provided faster pain relief than placebo in both studies (median 119 minutes in the abdominoplasty trial and 240 minutes in the bunionectomy trial vs 480 minutes for placebo in both trials; P<0.0001 and P=0.0016, respectively). Results indicated that suzetrigine was no better than hydrocodone/acetaminophen for acute pain relief.
The drug’s safety profile was based primarily on data from pooled trials of 874 abdominoplasty and bunionectomy patients, plus supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.
The most common adverse events in the studies were itching, muscle spasms, increased creatine phosphokinase levels, and rash. The drug is contraindicated for concomitant use with strong CYP3A inhibitors. Patients taking the drug also should avoid food or drinks containing grapefruit.
Before taking suzetrigine, patients should tell their healthcare provider about all medical conditions, including whether they are pregnant or breastfeeding, Vertex said. People with liver impairment may have an increased risk of side effects.
Some medications, including some hormonal birth control, may be less effective while on suzetrigine.
Vertex said it was studying suzetrigine in sciatica; in a phase 2 trial, the drug showed a statistically significant change in lumbosacral radiculopathy pain from baseline, similar to the reduction in the placebo arm. A phase 3 trial in painful diabetic peripheral neuropathy is also under way.
Medpage Today article – FDA Approves Novel Pain Pill Without Addiction Risk (Open access)
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