AQNEURSA (levacetylleucine)

Levacetylleucine pharmacokinetic parameters at steady state are presented as mean (SD) unless otherwise specified. Levacetylleucine maximum concentration (C max ) and area under the curve from time 0 to 24 hours (AUC 0-24hrs ) were 8.3 (3.3) µg/mL and 33.2 (12.5) h*μg/mL. No levacetylleucine accumulation occurs after repeated administration.

AbsorptionLevacetylleucine time to C max (T max ) is 1 hour (ranging from 0.5 to 2.5 hours).

DistributionLevacetylleucine apparent (oral) volume of distri...

The safety and efficacy of AQNEURSA for the treatment of NPC were evaluated in a randomized, double-blind, placebo-controlled, two-period crossover study (NCT05163288) that evaluated the efficacy of AQNEURSA in 60 patients. To be eligible for the study, patients had to be aged 4 years or older with a confirmed diagnosis of NPC. Patients were required to have at least mild disease-related neurological symptoms. Patients were assessed over a 2-week baseline period. Patients were then randomized in a 1:1 ratio to one of the two treatment sequences:

• Treatment Sequence 1 (N=30): AQNEURSA in Treat...

Most common adverse reactions (incidence ≥5% and greater than placebo) are abdominal pain, dysphagia, upper respiratory tract infections, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact IntraBio Inc. at 1-833-306-9677 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 clinical trials of a drug cannot be directly compared to rates in the c...

None. None. ( 4 )

Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 days after the last dose if AQNEURSA is discontinued. ( 5.1 ) 5.1 Embryo-Fetal Toxicity Based on findings from animal reproduction studies, AQNEURSA may cause embryo-fetal harm when administered during pregnancy. Administration of levacetylleucine to pregnant rats and rabbits during the period of organogenesis caused an increase in embryo-fetal death (p...

7 DRUG INTERACTIONS

• N-acetyl-DL-leucine or N-acetyl-D-leucine : Avoid concomitant use with AQNEURSA. ( 7.1 )
• P-glycoprotein (P-gp) Transporter Substrates : Monitor for adverse reactions if used with AQNEURSA. ( 7.2 ) 7.1 Effect of Other Drugs on AQNEURSA N-acetyl-DL-leucine and N-acetyl-D-leucine Avoid concomitant use of AQNEURSA with N-acetyl-DL-leucine and N-acetyl-D-leucine. The D-enantiome...