JOURNAVX

The pharmacokinetic parameters for suzetrigine and its major active metabolite, M6-SUZ, are shown in Table 4.

Table 4Pharmacokinetic Parameters of Suzetrigine and M6-SUZ Suzetrigine M6-SUZ (Active Metabolite) Based on an in vitro electrophysiology assay in human dorsal root ganglion neurons, M6-SUZ is a less potent inhibitor of Na V 1.8 than suzetrigine by 3.7-fold. AUC: area under the concentration versus time curve; CV: coefficient of variation; C max : maximum observed concentration; T max ...

14.1 Overview of Clinical Studies The efficacy of JOURNAVX in the treatment of moderate to severe acute pain in adults was established in two randomized, double-blind, placebo and active-controlled trials of acute pain, one following full abdominoplasty (Trial 1) [see Clinical Studies (14.2) ] and the other following bunionectomy (Trial 2) [see Clinical Studies (14.3) ] . In each trial, pain intensity was measured using a patient-reported 11-point numeric pain rating scale (NPRS), ranging from 0 to 10, where zero corresponds to no pain and 10 corresponds to the worst pain imaginable. Patients ...

The most common adverse reactions (greater incidence in JOURNAVX-treated patients compared to placebo-treated patients) were pruritus, muscle spasms, increased creatine phosphokinase, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinic...

Concomitant use of JOURNAVX with strong CYP3A inhibitors is contraindicated [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . Concomitant use with strong CYP3A inhibitors is contraindicated. ( 4 )

Moderate and Severe Hepatic Impairment : Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Use in patients with moderate hepatic impairment may increase the risk of adverse reactions. The recommended dosage is lower in patients with moderate hepatic impairment (Child-Pugh Class B) than those with normal hepatic function. ( 5.4 ) 5.1 Increased Risk of Adverse Reactions with Concomitant Use with Strong or Moderate CYP3A Inhibitors Strong and moderate CYP3A inhibitors incre...

7 DRUG INTERACTIONS Strong and Moderate CYP3A inhibitors : Concomitant use with strong CYP3A inhibitors is contraindicated. Reduce the JOURNAVX dose when used concomitantly with moderate CYP3A inhibitors. Avoid food or drink containing grapefruit. ( 2.3 , 7.1 , 12.3 ) Strong and Moderate CYP3A inducers : Avoid JOURNAVX use with strong or moderate CYP3A inducers. ( 7.1 , 12.3 ) CYP3A substrates : I...