An investigational drug to treat acromegaly has been granted Orphan Drug designation by the Food and Drug Administration (FDA).
Acromegaly is primarily caused by a benign pituitary adenoma and is characterized by the enlargement of the hands and feet, facial changes, hypertension, diabetes, and cardiomyopathy. DP1038 (octreotide acetate; Dauntless Pharmaceuticals), a somatostatin analog, uses the patented Intravail intranasal absorption technology developed by Aegis Therapeutics, offering patients a non-injectable alternative to treat this condition.
A phase 1 clinical study of DP1038 (Study of Intranasal Octreotide [DP1038] in Healthy Adult Volunteers; ClinicalTrials.gov identifier NCT03031535) demonstrated robust safety and pharmacodynamic data in healthy subjects.
FDA grants orphan drug designation to Dauntless Pharmaceuticals’ DP1038 for the treatment of acromegaly [news release]. San Diego, CA: Dauntless Pharmaceuticals. http://www.dauntlessph.com/fda-grants-orphan-drug-designation-dauntless-pharmaceuticals-dp1038-treatment-acromegaly/. Published January 30, 2018. Accessed February 5, 2018.
This article originally appeared on MPR