The FDA has granted orphan drug designation to Dauntless Pharmaceuticals’ DP1038 intranasal octreotide acetate for the treatment of acromegaly, the company said. Dauntless announced positive Phase 1 results for DP1038 in May 2015.
Dauntless Pharmaceuticals President and CEO Joel Martin commented, “The FDA’s decision to grant DP1038 orphan drug designation for the treatment of acromegaly is an important milestone in our program as we strive to bring patients a non-injectable alternative for the management of their disease. Granting of the designation highlights the unmet medical need for a new therapy that may transform the lives of these patients.”
The DP1038 formulation is based on intranasal absorption technology developed by Aegis Therapeutics and licensed by Dauntless in 2015, about a year after Aegis announced the availability of the license. In 2016, Aegis announced that it received US Patent No. 9,446,134 for intranasal formulation of octreotide.
Read the Dauntless Pharmaceuticals press release.
