FORZINITY (elamipretide hydrochloride)

Elamipretide exposure increases proportionally over a dose range of 2 to 80 mg following daily subcutaneous injections with minimal accumulation.

AbsorptionMaximum elamipretide concentrations were reached between 0.5 to 1 hour after subcutaneous administration. The absolute bioavailability following subcutaneous administration is approximately 92%. FORZINITY exposure is comparable after subcutaneous injection to the thigh or to the abdomen.

DistributionElamipretide is distributed throughout to...

FORZINITY was evaluated in a randomized, double-blind, placebo-controlled, crossover trial and its 192-week, open-label, single-arm extension period. The randomized trial evaluated the efficacy and safety of once daily FORZINITY 40 mg injected subcutaneously for 12 weeks in 12 subjects ≥12-years-old and >30 kg with genetically confirmed Barth syndrome. The primary endpoints for the randomized trial were distance walked during 6-minute walk test and Total Fatigue Score on the Barth syndrome Symptom Assessment. FORZINITY was not superior to placebo on these primary endpoints. Ten subjects comple...

Most common adverse reactions are injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Stealth BioTherapeutics Inc. at 1-844-444-6486 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 clinical trials of another drug and may not reflect the rates observed in pra...

Serious hypersensitivity to elamipretide or any of the excipients in FORZINITY [see Warnings and Precautions (5.2) ]. Serious hypersensitivity to any of the ingredients ( 4 , 5.2 )

Benzyl alcohol toxicity : Do not use in neonates. ( 5.1 ) 5.1 Risk of Benzyl Alcohol Toxicity in Neonates FORZINITY is not approved for use in neonates. Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates (less than 2,500 grams) and preterm neonates (gestational age less than 34 weeks) who received benzyl alcohol (BA)-containing drug...