Growth hormone therapy with a new delivery system

Area of Science:

• Pediatrics
• Endocrinology
• Drug Delivery Systems

Background:

• Traditional treatment for growth hormone deficiency (GHD) involved infrequent intramuscular injections.
• Recent findings support daily subcutaneous injections for enhanced growth rates in GHD children.
• Increased injection frequency necessitates user-friendly administration methods.

Purpose of the Study:

• To evaluate the patient acceptance and bioavailability of a novel injection pen system (Nordiject) for biosynthetic human growth hormone (B-hGH).
• To compare the efficacy and patient experience of the Nordiject pen versus conventional syringes for GHD treatment.

Main Methods:

• A study involving 27 children with growth retardation assessed pen handling and pain perception.
• A randomized cross-over study with 14 adult GHD patients compared B-hGH bioavailability via pen versus syringe.
• Bioavailability was measured using AUC, Cmax, and tmax parameters.

Main Results:

• Children reported no issues with pen handling, with two-thirds experiencing less pain compared to syringes.
• Patients previously using syringes strongly preferred the pen system.
• Bioavailability of B-hGH was equivalent when administered via the Nordiject pen or syringe in adult GHD patients.

Conclusions:

• The Nordiject injection pen is well-accepted by pediatric GHD patients, offering improved comfort.
• The pen system demonstrates comparable bioavailability to syringes, supporting its clinical utility for GHD treatment.
• The Nordiject pen provides a feasible and preferred alternative for daily B-hGH administration.